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TANZANIA FOOD AND DRUGS AUTHORITY (TFDA)

List of Registered Products (Government Gazette)


Print Date and Time:

18-August-2011

2:29:59PM

Human Medicinal Products


S/No:

Registration Number

Registrant
1.

D839

Product Name
Pack and Pack size

Ingredient(s) and Strength

D838

Dawa ya Mba,Lotion
6 %w/v
3 %w/v

24

A.A Pharmaceuticals Ltd.


TANZANIA

6 %w/w
3 %w/w

24

A.A Pharmaceuticals Ltd.


TANZANIA

Ketoprofen Ph Eur

2.5 %w/w

48

A1-STORE
TANZANIA

Ketoprofen BP

50 mg

60

A1-STORE
TANZANIA

Heparin Sodium Ph Eur

100,000 IU

48

A1-STORE
TANZANIA

Whitefield,Ointment

Benzoic Acid BP
Salicylic Acid BP

Registrant
3.

4.

5.

TAN 00,1759 M01A AMI

TAN 00,1760 M01A AMI

TAN 00,4180 B01A A.M

Registrant

Manufacturer

A.A Pharmaceuticals Ltd. - TANZANIA


Benzoic Acid BP
Salicylic Acid BP

2.

Shelf life
month

A1-STORE - TANZANIA
Fastum,Gel

Fastum,Capsules

Lioton,Gel

Abbott Laboratories S. A (Pty) Ltd. - SOUTH AFRICA


Page 1 of 584

Human Medicinal Products


S/No:

6.

Registration Number

TAN 09,081 J05A ABB

Product Name
Pack and Pack size

Ingredient(s) and Strength

8.

9.

10.

TAN 00,2090 J05A ABB

TAN 08,001 J05A ABB

TAN 00,2089 J05A ABB

TAN 09,0046B05B ABB

TAN 00,2091 J05A ABB

24

Lopinavir IH
Ritonavir IH

133.3 mg
33.3 mg

18

Abbott Laboratories Ltd.


UNITED KINGDOM

Lopinavir IH
Ritonavir IH

100 mg
25 mg

24

Abbot GmbH Co. KG


GERMANY

Lopinavir IH
Ritonavir IH

80 mg/ml
20 mg/ml

18

Abbott Laboratories Ltd.


UNITED KINGDOM

5.0 %w/v

36

Adcock Ingram Limited


SOUTH AFRICA

100 mg

12

Catalent Pharma Solutions


USA

Kaletra Soft,Capsules

Aluvia,Tablet

Kaletra,Solution

Glucose IV,Solution

Norvir Sec,Capsules

Ritonavir IH

Registrant

Cardinal Health
Manufacturing Services B.V
USA

100 mg

Dextrose Anhydrous BP

11.

Manufacturer

Norvir,Capsules

Ritonavir IH

7.

Shelf life
month

Activa Pharmaceuticals (FZC) - U.A.E

Page 2 of 584

Human Medicinal Products


S/No:

12.

Registration Number

Product Name
Pack and Pack size

TAN 07,422 P01B ACT

Artesunate +
Amodiaquine,Tablet

Ingredient(s) and Strength

50 mg
Artesunate IH
Amodiaquine Hydrochloride 200 mg
equivalent to Amodiaquine
IH

Registrant
13.

TAN 00,2278 J01F ADV

14.

15.

16.

17.

TAN 00,4524 C01E AEG

TAN 09,082 J01F AEG

TAN 05,718 J02A AEG

TAN 05,719 M01A AEG

24

Manufacturer

Activa Pharmaceuticals
(FZC)
U.A.E

Advanced Pharmaceuticals Co. Ltd - JORDAN


Zocin,Powder for Suspension
Advantage Research
Laboratories INC
USA

300 mg/7.5ml

24

Captopril USP

25 mg

48

Aegis Ltd.
CYPRUS

Clarithromycin Ph Eur

125 mg

36

Aegis Ltd.
CYPRUS

Fluconazole IH

150 mg

36

Aegis Ltd.
CYPRUS

Naproxen BP

250 mg

60

Aegis Ltd.
CYPRUS

Azithromycin USP

Registrant

Shelf life
month

Aegis Ltd - CYPRUS


Ropril,Tablet

Cleron,Syrup

Flucozal,Capsules

Naprorex,Tablet

Page 3 of 584

Human Medicinal Products


S/No:

18.

Registration Number

TAN 00,4523 J05A AEG

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 08,005 N02B AEG

60

Aegis Ltd.
CYPRUS

36

Aegis Ltd.
CYPRUS

200 mg

36

Aegis Ltd.
CYPRUS

Lansoprazole USP

30 mg

24

Aegis Ltd.
CYPRUS

Acyclovir Ph Eur

400 mg

36

Aegis Ltd.
CYPRUS

Ciprofloxacin Hydrochloride 500 mg


USP

36

Aglowmed Ltd
INDIA

200 mg

Tramadex,Capsules

Tramadol Hydrochloride Ph 50 mg
Eur

20.

TAN 08,004 J02A AEG

Flumycozal,Capsules

Fluconazole USP

21.

22.

TAN 08,003 A02B AEG

TAN 08,002 J05A AEG

Registrant
23.

TAN 07,002 J01K AGL

Manufacturer

Virucid,Tablet

Acyclovir BP

19.

Shelf life
month

Lasoprol 30,Capsules

Virucid,Tablet

Aglowmed Ltd - INDIA


Cifomed 500,Tablet

Page 4 of 584

Human Medicinal Products


S/No:

24.

25.

26.

Registration Number

TAN 07,001 R03A AGL

TAN 07,244 R05C AGL

TAN 07,424 J01H AGL

Product Name
Pack and Pack size

Ingredient(s) and Strength

28.

29.

TAN 07,423 J01H AGL

TAN 09,038 J01K AGL

TAN 09,037 J01K AGL

Manufacturer

Instaryl,Syrup

Bromhexine Hydrochloride 8 mg
BP
Salbutamol Sulphate
4 mg
equivalent to Salbutamol BP
Phenylephrine
5 mg
Hydrochloride BP

18

Aglowmed Ltd
INDIA

Diphenhydramine
Hydrochloride BP
Menthol BP
Ammonium Chloride BP

36

Aglowmed Ltd
INDIA

18

Aglowmed Ltd
INDIA

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

18

Aglowmed Ltd
INDIA

Levofloxacin IH

500 mg

36

Aglowmed Ltd
INDIA

Levofloxacin Hemihydrate
IH

250 mg

24

Aglowmed Ltd
INDIA

Becoryl,Syrup
14 mg/5ml
1.14 mg/5ml
138 mg/5ml

Sinmox,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

27.

Shelf life
month

Sinmox-250,Capsules

Lemed,Tablet

Lemed,Tablet

Page 5 of 584

Human Medicinal Products


S/No:

30.

Registration Number

TAN 10,001 R05F

Product Name
Pack and Pack size

Ingredient(s) and Strength

31.

32.

33.

TZ10H116

TZ10H117

TZ10H118

34.

TAN 09,084 A16A AJA

2 mg/5ml

24

Aglowmed Ltd
INDIA

5 mg/5ml
50 mg/5ml
75 mg/5ml

Agog Pharma Ltd - INDIA


Agomove,Capsules

Piroxicam USP

20 mg

36

Agog Pharma Ltd


INDIA

Paracetamol BP

500 mg

48

Agog Pharma Ltd


INDIA

250 mg

36

Agog Pharma Ltd


INDIA

15 mg
100 mg
150 mg
70 mg
75 mg
25 mg

18

Ajanta Pharma Ltd.


INDIA

Agomol,Tablets

Agophenol,Capsules

Chloramphenicol BP

Registrant

Manufacturer

Instaryl -D,Syrup

Chlorpheniramine Maleate
BP
Dextromethorphan
Hydrobromide BP
Guaiphenesin BP
Ammonium Chloride BP

Registrant

Shelf life
month

Ajanta Pharma Ltd - INDIA


Carofit,Tablet

Carotenoids IH
Carrot extract IH
Ascorbic Acid USP
Zinc Sulphate USP
Selenium Dioxide USP
Tocopheryl Acetate
Nicotinamide
Dexapanthenol USP

Page 6 of 584

Human Medicinal Products


S/No:

35.

36.

37.

Registration Number

TAN 09,087 P01B AJA

TAN 09,268 C04A AJA

TAN 09,267 C04A AJA

Registrant
38.

TAN 00,4258 B05B ALB

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 06,002 B05B ALB

Lumefantrine IH
Artemether IP

480 mg
80 mg

24

Ajanta Pharma Ltd


INDIA

Sildenafil Citrate IH

50 mg

36

Ajanta Pharma Ltd


INDIA

Sildenafil Citrate IH

100 mg

36

Ajanta Pharma Ltd


INDIA

5 g/100ml

36

Albert David Ltd.


INDIA

0.5 mg/100ml
0.9 mg/100ml

24

Albert David Ltd.


INDIA

10 g/100ml

24

Albert David Ltd.


INDIA

Kamagra,Tablet

Kamagra,Tablet

Albert David Ltd. - INDIA


Glucose,Solution

Sodium Chloride +
Glucose,Intravenous solution

Glucose Anhydrous BP
Sodium Chloride BP

40.

TAN 06,003 B05B ALB

Manufacturer

Artefan,Tablet

Glucose Anhydrous BP

39.

Shelf life
month

Glucose IV,Solution

Glucose BP

Page 7 of 584

Human Medicinal Products


S/No:

41.

Registration Number

TAN 06,004 B05B ALB

Product Name
Pack and Pack size

Ingredient(s) and Strength

43.

TAN 06,001 B05B ALB

TAN 06,005 A12C ALB

Registrant
44.

TAN 00,1538 S01E ALC

0.9 %w/v

24

Albert David Ltd.


INDIA

Glucose BP

5 g/100ml

24

Albert David Ltd.


INDIA

Calcium Chloride BP
Sodium Chloride BP
Sodium Lactate BP
Potassium Chloride BP

0.027 g/100ml
0.6 g/100ml
0.320 g/100ml
0.04 g/100ml

24

Albert David Ltd.


INDIA

0.5 %w/v

36

Alcon Cusi, S.A.


SPAIN

40 mg/ml

36

Alcon Cusi, S.A.


SPAIN

Polyethylene Glycol 400 NF 0.4 %w/v


0.3 %w/v
Propylene Glycol USP

36

Alcon Cusi, S.A.


SPAIN

Glucose IV,Solution

Compound Sodium
Lactate,Solution

Alcon Cusi, S.A. - SPAIN


Cusimolol,Ophthalmic
Solution

Timolol Maleate Ph Eur

45.

TAN 00,1761 S01G ALC

Cusicrom,Ophthalmic
Solution

Sodium Cromoglycate Ph
Eur

46.

TAN 07,247 S03D ALC

Registrant

Manufacturer

Sodium Chloride,Solution

Sodium Chloride BP

42.

Shelf life
month

Systane Lubricating Eye


Drops,Solution

Alcon-Couvreur NV - BELGIUM

Page 8 of 584

Human Medicinal Products


S/No:

47.

48.

49.

50.

Registration Number

TAN 06,102 J01K S.A

TAN 06,334 D04A S.A

TAN 06,334 D04A S.A

TAN 06,335 S01D S.A

Product Name
Pack and Pack size

Ingredient(s) and Strength

52.

53.

TAN 06,335 S01D S.A

TAN 06,349 S01C ALC

TAN 06,350 S01C ALC

Manufacturer

Ciloxan,Ophthalmic Solution

Ciprofloxacin Hydrochloride 3 mg/5ml


IH

24

S K AGE Exports
INDIA

Olopatadine Hydrochloride
IH

0.1 %

36

S K AGE Exports
INDIA

Olopatadine Hydrochloride
IH

0.1 %

36

S K AGE Exports
INDIA

10 mg/ml

24

S K AGE Exports
INDIA

Brinzolamide IH

10 mg/ml

24

S K AGE Exports
INDIA

Dexamethasone Ph Eur
Tobramycin Ph Eur

0.1 %
0.3 %

24

Alcon-Couvreur NV
BELGIUM

1 mg/ml
3 mg/ml

24

Alcon-Couvreur NV
BELGIUM

Patanol,Solution

Patanol,Solution

Azopt,Ophthalmic suspension

Brinzolamide IH

51.

Shelf life
month

Azopt,Ophthalmic suspension

Tobradex,Drops

Tobradex,Ophthalmic
Ointment

Dexamethasone Ph Eur
Tobramycin Ph Eur

Page 9 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
54.

TAN 07,249 J01F ALE

Product Name
Pack and Pack size

Ingredient(s) and Strength

55.

56.

57.

58.

TAN 00,217 R05C ALE

TAN 00,608 B03A ALE

TAN 00,4050 D04A ALE

TAN 00,4051 J01F ALE

Manufacturer

Alembic Chemical Works Co Ltd. - INDIA


Azithral,Tablet
500 mg

24

Alembic Ltd.
INDIA

Bromhexine Hydrochloride
BP
Diphenhydramine
Hydrochloride BP
Guaiphenesin BP
Menthol BP
Ammonium Chloride BP

4 mg/5ml

24

Alembic Ltd
INDIA

Diphenhydramine
Hydrochloride BP
Phenylpropanolamine
Hydrochloride BP
Dextromethorphan
Hydrochloride BP

8.24 mg/5ml

36

Alembic Ltd
INDIA

Loratadine IH

10 mg

24

Alembic Ltd
INDIA

40 mg/ml

24

Alembic Ltd
INDIA

Azithromycin Dihydrate
equivalent to Azithromycin
BP

Registrant

Shelf life
month

Alembic Limited - INDIA


Zeet,Syrup

8.5 mg/5ml
50 mg/5ml
1 mg/5ml
100 mg/5ml

Ephedrex,Syrup

12.88 mg/5ml
10 mg/5ml

Lormeg,Tablet

Azithral,Suspension

Azithromycin Dihydrate
equivalent to Azithromycin
USP

Page 10 of 584

Human Medicinal Products


S/No:

59.

60.

61.

62.

63.

64.

Registration Number

TAN 00,4052 J01F ALE

TAN 00,4259 N02B ALE

TAN 05,004 R05A ALE

TAN 00,260 J01H ALE

TAN 06,240 R02A ALE

TAN 06,241 R05C ALE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Clarithro,Tablet

Clarithromycin equivalent to 250 mg


Anhydrous Clarithromycin
Ph Eur

24

Alembic Ltd
INDIA

Celecoxib IH

100 mg

24

Alembic Ltd
INDIA

Bromhexine Hydrochloride
BP
Terbutaline Sulphate BP
Sodium Benzoate BP

4.2 mg

18

Alembic Ltd
INDIA

Benzyl penicillin Sodium BP 1 MU


3 MU
Procaine Penicillin BP

48

Alembic Ltd
INDIA

Bromhexine Hydrochloride
BP
Diphenhydramine
Hydrochloride BP
Guaiphenesin BP
Levomenthol BP
Ammonium Chloride BP

4 mg/5ml

24

Alembic Ltd.
INDIA

Levomenthol BP
Dextromethorphan
Hydrochloride BP
Terpin Hydrate USP

3.750 mg/5ml
10 mg/5ml

24

Alembic Ltd.
INDIA

Sionara,Capsules

Brozeet,Syrup

1.575 mg
15 mg

PPF,Injection

Zeet,Syrup

8 mg/5ml
50 mg/5ml
1 mg/5ml
100 mg/5ml

Glycodin,Syrup

Page 11 of 584

10 mg/5ml

Human Medicinal Products


S/No:

65.

Registration Number

TAN 06,242 J01F ALE

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 07,251 J01F ALE

250 mg

24

Alembic Ltd.
INDIA

200 mg

36

Alembic Ltd.
INDIA

1.5 mg/5ml
Terbutaline Sulphate BP
50 mg/5ml
Guaiphenesin BP
Ambroxol Hydrochloride BP 15 mg/5ml

24

Alembic Ltd.
INDIA

Erythromycin Stearate
equivalent to Erythromycin
BP

250 mg

36

Alembic Ltd.
INDIA

Bromhexine Hydrochloride
BP
Diphenhydramine
Hydrochloride BP
Guaiphenesin BP
Levomenthol BP
Ammonium Chloride BP

4 mg/5ml

24

Alembic Ltd.
INDIA

Bromhexine Hydrochloride
BP
Diphenhydramine
Hydrochloride BP
Guaiphenesin BP
Levomenthol BP
Ammonium Chloride BP

4 mg/5ml

24

Alembic Ltd.
INDIA

Azithral,Suspension

Azithromycin Dihydrate
equivalent to Azithromycin
USP
67.

68.

69.

70.

TAN 07,250 R05A ALE

TAN 08,024 J01F ALE

TAN 06,240 R02A ALE

TAN 06,240 R02A ALE

Manufacturer

Azithral,Tablet

Azithromycin Dihydrate
equivalent to Azithromycin
USP
66.

Shelf life
month

Brozeet,Syrup

Althrocin-S,Tablet

Zeet,Syrup

8 mg/5ml
50 mg/5ml
1 mg/5ml
100 mg/5ml

Zeet,Syrup

Page 12 of 584

8 mg/5ml
50 mg/5ml
1 mg/5ml
100 mg/5ml

Human Medicinal Products


S/No:

71.

72.

Registration Number

TAN 06,242 J01F ALE

TAN 06,242 J01F ALE

Registrant
73.

TAN 09,088 S01D ALC

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 07,253 J01C ALK

Azithromycin Dihydrate
equivalent to Azithromycin
USP

250 mg

24

Alembic Ltd.
INDIA

Azithromycin Dihydrate
equivalent to Azithromycin
USP

250 mg

24

Alembic Ltd.
INDIA

0.1 %

18

Alkem Laboratories Ltd.


INDIA

36

Alkem Laboratories Ltd


INDIA

1 g/vial

24

Vital Healthcare Pvt Ltd.


INDIA

Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

18

Alkem Laboratories Ltd.


INDIA

Azithral,Tablet

Alkem Laboratories Ltd - INDIA


Nevanac,Ophthalmic Solution

Cloxacillin,Capsules

Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

75.

TAN 00,2099 J01D ALK

Tazid,Injectable Solution

Ceftazidime USP

76.

TAN 00,4058 J01C ALK

Manufacturer

Azithral,Tablet

Nepafenac IH

74.

Shelf life
month

Broadiclox,Capsules

Page 13 of 584

Human Medicinal Products


S/No:

77.

Registration Number

TAN 00,4061 J01K ALK

Product Name
Pack and Pack size

Ingredient(s) and Strength

Vancogen,Powder for
Injection

79.

80.

81.

82.

TAN 00,2100 J01C ALK

TAN 00,2102 J01C ALK

TAN 00,4260 J01C ALK

TAN 00,4393 J01C ALK

TAN 05,005 A02B ALK

Manufacturer

500 mg

30

Alkem Laboratories Ltd.


INDIA

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin
USP

18

Alkem Laboratories Ltd


INDIA

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin
USP

18

Alkem Laboratories Ltd.


INDIA

Clavulanate Potassium USP 125 mg/5ml


Amoxicillin Trihydrate
250 mg/5ml
equivalent to Amoxicillin
USP

24

Alkem Laboratories Ltd.


INDIA

Clavulanate Potassium IH
Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

28.5 mg/5ml
200 mg/5ml

24

Alkem Laboratories Ltd.


INDIA

Omeprazole IH

20 mg

30

Alkem Laboratories Ltd.


INDIA

Vancomycin Hydrochloride
USP

78.

Shelf life
month

Clavam,Tablet

Clavam,Tablet

Clavam,Tablet

Clavam,Powder for
Suspension

Omepraz,Capsules

Page 14 of 584

Human Medicinal Products


S/No:

83.

84.

85.

Registration Number

TAN 05,085 J01D ALK

TAN 05,086 J01D ALK

TAN 05,084 J01K ALC

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,575 J01K ALC

Cefixime Trihydrate USP

200 mg

24

Alkem Laboratories Ltd.


INDIA

Cefixime Trihydrate USP

50 mg/5ml

18

Alkem Laboratories Ltd.


INDIA

24

Alkem Laboratories Ltd.


INDIA

24

Alkem Laboratories Ltd.


INDIA

36

Alkem Laboratories Ltd.


INDIA

24

Vital Healthcare Pvt Ltd.


INDIA

36

Alkem Laboratories Ltd.


INDIA

Taxim-O,Syrup

Cilodex,Suspension

Vigamox,Ophthalmic Solution

Moxifloxacin Hydrochloride 0.5 %w/v


IH

87.

TAN 06,006 J01H ALK

Ampihold,Powder for
Injection

Ampicillin Sodium
1g
equivalent to Ampicillin IHS

88.

TAN 00,2099 J01D ALK

Tazid,Injectable Solution

Ceftazidime Sodium USP


Ceftazidime USP

89.

TAN 07,252 J01H ALK

Manufacturer

Taxim-O,Tablet

Ciprofloxacin Hydrochloride 0.3 %w/v


USP
0.1 %w/v
Dexamethasone USP
86.

Shelf life
month

Cloxahold,Powder for
Injection

1000 mg
1 g/vial

Cloxacillin Sodium
500 mg
equivalent to Cloxacillin BP

Page 15 of 584

Human Medicinal Products


S/No:

90.

Registration Number

TAN 07,428 J01D ALK

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 07,427 J01C ALK

36

Alkem Laboratories Ltd


INDIA

24

Alkem Laboratories Ltd.


INDIA

125 mg/5ml
125 mg/5ml

18

Alkem Laboratories Ltd.


INDIA

125 mg/ml

30

Alkem Laboratories Ltd.


INDIA

290.698 mg
280 mg
250 mg

36

Alkem Laboratories Ltd.


INDIA

30

Alkem Laboratories Ltd.


INDIA

250 mg

Cloxacillin,Powder for
Suspension

Cloxacillin Sodium
125 mg/5ml
equivalent to Cloxacillin BP

92.

TAN 07,426 J01C ALK

Broadiclox,Powder for
Suspension

Ampicillin BP
Cloxacillin BP

93.

TAN 07,425 J01C ALK

Flucloxacillin,Powder for
Reconstitution

Flucloxacillin BP

94.

TAN 00,4058 J01C ALK

Broadiclox,Capsules

Ampicilin Trihydrate BP
Cloxacillin Sodium BP
Ampicillin Trihydrate
equivalent to Ampicillin BP
Cloxacillin Sodium
equivalent to Cloxacillin BP
95.

TAN 10,003 J01D

Manufacturer

Cephalkem,Capsules

Cephalexin BP

91.

Shelf life
month

Cephalkem,Powder for
Suspension

Cefalexin BP

Page 16 of 584

250 mg

125 mg/5ml

Human Medicinal Products


S/No:

96.

97.

98.

99.

100.

Registration Number

TAN 05,085 J01D ALK

TAN 05,086 J01D ALK

TAN 00,2100 J01C ALK

TAN 10, 049 J01C

TZ10H134

Product Name
Pack and Pack size

Ingredient(s) and Strength

101.

TAN 00,4436 S01D ALL

Manufacturer

Taxim-O,Tablet
24

Alkem Laboratories Ltd.


INDIA

18

Alkem Laboratories Ltd.


INDIA

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin
USP

18

Alkem Laboratories Ltd


INDIA

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate eq to 875 mg
Amoxicillin USP

24

Alkem Laboratories Ltd.


INDIA

Cefixime Trihydrate
equivalent to Cefixime USP
Cefixime Trihydrate USP

200 mg

Cefixime Trihydrate USP

61.333 mg/5ml

200 mg

Taxim-O,Syrup

Clavam,Tablet

Clavam,Tablet

Magtam 1G,Powder for


Injection

Sulbactam Sodium eq to
Sulbactam USP
Cefoperazone Sodium eqvt
to Cefoperazone USP

Registrant

Shelf life
month

500 mg

24

500 mg

ALKEM LABORATORIES
LTD.
INDIA

Allergan Pharmaceuticals (Pty) Ltd. - SOUTH AFRICA


Albalon A
Liquifilm,Ophthalmic
Antazoline Phosphate
Solution

5 mg/ml

Ph.Eur/USP
Naphazoline Hydrochloride 0.5 mg/ml
Ph.Eur/USP

Page 17 of 584

36

Allergan Pharmaceuticals
(Ireland) Ltd.
REPUBLIC OF IRELAND

Human Medicinal Products


S/No:

102.

Registration Number

TAN 00,4437 S01D ALL

Product Name
Pack and Pack size

Ingredient(s) and Strength

Oxylin Liquifilm,Ophthalmic
Solution

103.

104.

105.

106.

107.

TAN 00,1037 C03A COX

TAN 00,1041 M04A COX

TAN 00,654 C06A COX

TAN 00,655 C06A COX

TAN 00,1032 C04A COX

Allergan Pharmaceuticals
(Ireland) Ltd.
REPUBLIC OF IRELAND

36

Bendrofluazide BP

5 mg

36

Alpharma Ltd.
UNITED KINGDOM

Allopurinol BP

100 mg

36

Alpharma Ltd.
UNITED KINGDOM

Atenolol Ph Eur

100 mg

36

Alpharma Ltd.
UNITED KINGDOM

Atenolol Ph Eur

50 mg

36

Alpharma Ltd.
UNITED KINGDOM

10 mg

24

Alpharma Ltd.
UNITED KINGDOM

Alpharma Ltd. - UNITED KINGDOM


Bendrofluazide,Tablet

Allopurinol,Tablet

Atenolol,Tablet

Atenolol,Tablet

Isosorbide Mononitrate,Tablet

Isosorbide Mononitrate BP

Registrant

Manufacturer

0.25 mg/ml

Oxymetazoline
Hydrochloride USP

Registrant

Shelf life
month

Amoun Pharmaceutical Industries Co - EGYPT

Page 18 of 584

Human Medicinal Products


S/No:

108.

109.

110.

111.

112.

Registration Number

TAN 00,353 A06A AMO

TAN 00,519 D01A AMO

TAN 00,520 D04A AM0

TAN 09,140 D01A GSK

TAN 00,2475 A11A AMO

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Enemax,Solution
GlaxoSmithKline Egypt
EGYPT

Dibasic Sodium Phosphate 6 g/100ml


BP
Sodium Acid Phosphate BP 16 g/100ml

36

Tretinoin USP

0.055 g/100g

36

Cetylpyridinium Chloride
USP
Lidocaine Hydrochloride
USP

0.1 g/100g

36

GlaxoSmithKline Egypt
EGYPT

Tretinoin USP

0.02 %w/w

36

GlaxoSmithKline Egypt
EGYPT

75 mg
350 mg
5 mg
2.5 mg
10 mg
50 mg
2 mg
2.5 mg
15 mg
7.5 mg
2 mg
400 IU
200 mg
45 mg
15 mg

36

Acne Free,Cream
Amoun Pharmaceutical
Industries Co.
EGYPT

Oracure,Gel

2 g/100g

Acne Free,Gel

Haema Caps,Capsules

Calcium Gluconate BP
Ferrous Fumarate BP
Tocopheryl Acetate BP
Manganese BP
Pyridoxine BP
Ascorbic Acid BP
Folic Acid BP
Copper Sulphate BP
Thiamine BP
Cyanocobalamine BP
Riboflavine BP
Cholecalciferol BP
Linoleic Acid BP
Linolenic Acid BP
Taurine IH
Page 19 of 584

Amoun Pharmaceutical
Industries Co.
EGYPT

Human Medicinal Products


S/No:

Registration Number

113.

TAN 00,2473 M03B AMO

114.

115.

116.

TAN 00,2469 P01A AMO

TAN 00,2468 A11E AMO

TAN 00,2472 A11E AMO

Registrant
117.

TAN 00,2483 B02B AMR

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,065 V03A AMR

Manufacturer

Roysan,Tablet

Tizanidine Hydrochloride IH 4 mg

36

Secnidazole IH

500 mg

36

Pyridoxine Hydrochloride
BP
Thiamine Hydrochloride BP
Cyanocobalamine BP
Lidocaine Hydrochloride BP
Riboflavine Phosphate BP

100 mg

36

Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Hydrochloride BP
Folic Acid BP
Cyanocobalamine BP
Riboflavine BP

200 mg

Amoun Pharmaceutical
Industries Co.
EGYPT

Fladazole,Tablet
Amoun Pharmaceutical
Industries Co.
EGYPT

Neuroton,Injectable Solution

200 mg
1 mg
10 mg
4 mg

Amoun Pharmaceutical
Industries Co.
EGYPT

Neuroton,Tablet
36

250 mg
0.5 mg
0.25 mg
20 mg

Amoun Pharmaceutical
Industries Co.
EGYPT

Amriya Pharmaceutical Industry Company, - EGYPT


Amri K,Injectable Solution

Phytomenadione BP

118.

Shelf life
month

10 mg/ml

36

500 mg
100000 IU

36

Amriya Pharmaceutical
Industry Company,
EGYPT

Amrizole N,Pessaries

Metronidazole BP
Nystatin BP

Page 20 of 584

Amriya Pharmaceutical
Industry Company,
EGYPT

Human Medicinal Products


S/No:

Registration Number

Registrant
119.

120.

121.

122.

123.

124.

TAN 06,007 R06A ANF

TAN 06,008 V07A ANF

TAN 06,010 D01A ANF

TAN 06,011 A02B ANF

TAN 06,116 J02A ANF

TAN 06,117 J01K ANF

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Anfarm Hellas S.A - GREECE


Latoren,Tablet

Loratadine Ph Eur

10 mg

36

Anfarm Hellas S.A


GREECE

Simvastatin Ph Eur

20 mg

36

Anfarm Hellas S.A


GREECE

Bifonazole Ph Eur

1 %w/w

36

Anfarm Hellas S.A


GREECE

Omeprazole Ph Eur

40 mg/10ml

36

Anfarm Hellas S.A


GREECE

Fluconazole Ph Eur

150 mg

36

Anfarm Hellas S.A


GREECE

Ciprofloxacin Ph Eur

500 mg

36

Anfarm Hellas S.A


GREECE

Sivinar,Tablet

Myco-Flusemidon,Cream

Eselan,Powder

Flusenil,Capsules

Aristin-C,Tablet

Page 21 of 584

Human Medicinal Products


S/No:

125.

Registration Number

TAN 06,118 J01D ANF

Product Name
Pack and Pack size

Ingredient(s) and Strength

127.

128.

129.

130.

131.

TAN 06,119 J01D ANF

TAN 06,352 A02B ANF

TAN 06,353 J01D ANF

TAN 06,354 R01A ANF

TAN 06,351 J01K ANF

TAN 06,469 N06A ANF

Manufacturer

Stoparen,Powder for Injection


24

Anfarm Hellas S.A


GREECE

Ceftriaxone Sodium Ph Eur 1 g

24

Anfarm Hellas S.A


GREECE

Omeprazole Ph Eur

36

Anfarm Hellas S.A


GREECE

Cefuroxime Sodium Ph Eur 750 mg/vial

36

Anfarm Hellas S.A


GREECE

Sodium Cromoglycate Ph
Eur

4 %w/v

24

Anfarm Hellas S.A


GREECE

Amikacin Sulphate Ph Eur

500 mg/2ml

24

Anfarm Hellas S.A


GREECE

Fluoxetine Hydrochloride
Ph Eur

20 mg

36

Anfarm Hellas S.A


GREECE

Cefotaxime Sodium Ph Eur 1 g

126.

Shelf life
month

Travilan,Powder for Injection

Eselan,Capsules
20 mg

Nipogalin,Powder

Kaosyl,Solution

Amikan,Injectable Solution

Flonital,Capsules

Page 22 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
132.

133.

134.

TAN 00,4525 A02A ARI

TAN 00,4504 C01K ARI

TAN 00,4503 V07A ARI

Product Name
Pack and Pack size

Ingredient(s) and Strength

136.

137.

TAN 05,006 V02C ARI

TAN 00,4580 A10B ARI

TAN 05,462 J01D ARI

Manufacturer

Aristo Pharmaceuticals Private Ltd. - INDIA


Chexid,Capsules

Lansoprazole USP

30 mg

24

Losartan Potasium IH

50 mg

24

Aristo Pharmaceuticals Pvt


.Ltd.
INDIA

Alsartan,Tablet
Aristo Pharmaceuticals Pvt
.Ltd.
INDIA

Bigomet,Tablet

Metformin Hydrochloride BP 500 mg

135.

Shelf life
month

24

Aristo Pharmaceuticals Pvt


.Ltd.
INDIA

Monocef,Powder for Injection

Ceftriaxone Sodium
equivalent to Anhydrous
Ceftriaxone USP

1g

24

Gliclazide BP

80 mg

24

Cefaclor Monohydrate USP

125 mg/5ml

18

Aristo Pharmaceuticals Pvt


.Ltd.
INDIA

Glycigon,Tablet
Aristo Pharmaceuticals Pvt
.Ltd.
INDIA

Halocef,Suspension

Page 23 of 584

Aristo Pharmaceuticals
Private Ltd.
INDIA

Human Medicinal Products


S/No:

138.

139.

140.

141.

142.

Registration Number

TAN 05,720 J01D ARI

TAN 05,721 A02B ARI

TAN 05,723 A10B ARI

TAN 05,722 A10B ARI

TAN 07,254 R05C ARI

Product Name
Pack and Pack size

Ingredient(s) and Strength

143.

TAN 08,159 P01B ART

Cefpodoxime Proxetil
equivalent to Cefpodoxime
USP

200 mg

24

Pantoprazole Sodium
Sesquihydrate eq to
Pantoprazole IH

40 mg

24

Rosiglitazone Maleate IH

2 mg

24

Rosiglitazone Maleate
equivalent to Rosiglitazone
IH

4 mg

24

Aristo Pharmaceuticals Pvt


.Ltd.
INDIA

Pantop,Tablet
Aristo Pharmaceuticals
Private Ltd.
INDIA

Roglin-2,Tablet
Aristo Pharmaceuticals
Private Ltd.
INDIA

Roglin-4,Tablet
Aristo Pharmaceuticals
Private Ltd.
INDIA

Ambrodil,Syrup
30

Aristo Pharmaceuticals Pvt


.Ltd.
INDIA

Artepharm Co. Ltd. - CHINA


Artequik,Tablet

Piperaquine Phosphate IH
Artemisinin IH

Registrant

Manufacturer

Monocef-O,Tablet

Ambroxol Hydrochloride BP 3 mg/5ml

Registrant

Shelf life
month

375 mg
62.5 mg

Aspen Pharmacare Ltd - SOUTH AFRICA

Page 24 of 584

24

Guangdong Medi-World
Pharmaceutical Co. Ltd.
CHINA

Human Medicinal Products


S/No:

144.

Registration Number

TAN 06,121 J05A ASP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 06,122 J05A ASP

TAN 06,123 J05A ASP

TAN 06,124 J05A ASP

TAN 06,129 J05A ASP

TAN 06,125 J05A ASP

TAN 06,126 J05A ASP

24

Aspen Pharmacare.
SOUTH AFRICA

50 mg/5ml

24

Aspen Pharmacare.
SOUTH AFRICA

200 mg

24

Aspen Pharmacare.
SOUTH AFRICA

20 mg

24

Aspen Pharmacare.
SOUTH AFRICA

30 mg

24

Aspen Pharmacare.
SOUTH AFRICA

15 mg

24

Aspen Pharmacare.
SOUTH AFRICA

Aspen Stavudine,Capsules

Stavudine IH

150.

300 mg

Aspen Stavudine,Capsules

Stavudine IH

149.

Aspen Pharmacare.
SOUTH AFRICA

Aspen Nevirapine,Tablet

Nevirapine IH

148.

24

Aspen Zidovudine,Syrup

Zidovudine IH

147.

10 mg/ml

Aspen Zidovudine,Tablet

Zidovudine IH

146.

Manufacturer

Aspen Lamivudine,Solution

Lamivudine IH

145.

Shelf life
month

Aspen Stavudine,Capsules

Stavudine IH

Page 25 of 584

Human Medicinal Products


S/No:

151.

152.

153.

Registration Number

TAN 06,127 J05A ASP

TAN 06,128 J05A ASP

TAN 06,243 J05A ASP

Product Name
Pack and Pack size

Ingredient(s) and Strength

154.

155.

156.

TAN 07,246 J01F AJA

TAN 07,245 A02B AJA

TZ10H107

Registrant

Manufacturer

Aspen Lamzid,Tablet

Aspen Lamzid +
Nevirapine,Tablet

Lamivudine IH
Zidovudine IH

150 mg
300 mg

24

Aspen Pharmacare.
SOUTH AFRICA

Lamivudine IH
Nevirapine IH
Zidovudine IH

150 mg
200 mg
300 mg

24

Aspen Pharmacare.
SOUTH AFRICA

150 mg

24

Aspen Pharmacare.
SOUTH AFRICA

Clarithromycin USP

500 mg

36

Astra Pharma(T) Ltd.


TANZANIA

Omeprazole BP

20 mg

36

Astra Pharma(T) Ltd.


TANZANIA

Levofloxacin Hemihydrate
equivalent to Levofloxacin
IH

500 mg

24

Astra Pharma(T) Ltd.


TANZANIA

Aspen Lamivudine,Tablet

Lamivudine IH

Registrant

Shelf life
month

Astra Pharma(T) Ltd. - TANZANIA


Claranta,Tablet

Aprazole,Capsules

Levotop,Tablets

Astra Zenaca - UNITED KINGDOM

Page 26 of 584

Human Medicinal Products


S/No:

157.

Registration Number

TAN 00,4182 C06A AST

Product Name
Pack and Pack size

Ingredient(s) and Strength

158.

TAN 00,4444 J01D AST

TAN 00,4443 J01D AST

Cefotaxime,Powder for
Injection

TAN 00,4442 J01D AST

161.

TAN 07,003 N02B AST

TAN 07,123 J01K AST

1000 mg

36

1000 mg

36

750 mg/vial

36

Astral Pharmaceutical
Industries
INDIA

Astral Pharmaceutical
Industries
INDIA

Astral Pharmaceutical
Industries
INDIA

Astralifecare (India) Pvt.Ltd. - INDIA


Asmol,Tablet
500 mg

36

Astralifecare (India) Pvt.Ltd.


INDIA

Ciprofloxacin Hydrochloride 500 mg


BP

36

Astralifecare (India) Pvt.Ltd.


INDIA

Paracetamol BP

162.

Astra Zenaca
UNITED KINGDOM

Cefast,Powder for Injection

Cefuroxime Sodium USP

Registrant

36

Ceftral,Powder for Injection

Ceftriaxone Sodium USP

160.

50 mg
12.5 mg

Astral Pharmaceutical Industries - INDIA


Cefotaxime Sodium
Equivalent to Cefotaxime
USP

159.

Manufacturer

Tenoretic,Tablet

Atenolol Ph Eur
Chlorthalidone Ph Eur

Registrant

Shelf life
month

Asflox,Tablet

Page 27 of 584

Human Medicinal Products


S/No:

163.

164.

165.

166.

167.

168.

169.

Registration Number

TAN 07,122 J03B AST

TAN 07,121 J01H AST

TAN 07,119 J02A AST

TAN 07,120 P01A AST

TAN 07,124 J01H AST

TAN 07,264 A02B AST

TAN 07,257 J01C AST

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Astrim,Tablet

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

24

Astralifecare (India) Pvt.Ltd.


INDIA

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

24

Astralifecare (India) Pvt.Ltd.


INDIA

Ketoconazole USP

200 mg

36

Astralifecare (India) Pvt.Ltd.


INDIA

Metronidazole BP

200 mg

36

Astralifecare (India) Pvt.Ltd.


INDIA

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

Astralifecare (India) Pvt.Ltd.


INDIA

Cimetidine USP

400 mg

36

Astralifecare (India) Pvt.Ltd.


INDIA

Cloxacillin Sodium
equivalent to Cloxacillin
USP

250 mg

36

Astralifecare (India) Pvt.Ltd.


INDIA

Ascillin,Capsules

Dermizol,Tablet

Astrogyl,Tablet

Asmox,Capsules

Astidin,Tablet

Asclox,Capsules

Page 28 of 584

Human Medicinal Products


S/No:

170.

171.

172.

173.

174.

175.

Registration Number

TAN 07,262 R06A AST

TAN 07,263 J01A AST

TAN 07,260 D01B AST

TAN 07,256 M01A AST

TAN 07,258 M01A AST

TAN 07,421 J01F AST

Registrant

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Aspi-M,Tablet

Chlorpheniramine Maleate
BP

4 mg

24

Astralifecare (India) Pvt.Ltd.


INDIA

Doxycycline BP

100 mg

24

Astralifecare (India) Pvt.Ltd.


INDIA

Griseofulvin BP

500 mg

36

Astralifecare (India) Pvt.Ltd.


INDIA

Diclofenac Sodium BP

50 mg

36

Astralifecare (India) Pvt.Ltd.


INDIA

Ibuprofen BP

200 mg

36

Astralifecare (India) Pvt.Ltd.


INDIA

Eryrthromycin Stearate USP 250 mg

24

Astralifecare (India) Pvt.Ltd.


INDIA

Asdoxin,Capsules

Asfulvin,Tablet

Dicloas,Tablet

Asfen,Tablet

Asomycin,Tablet

AstraZeneca Ltd. - UNITED KINGDOM

Page 29 of 584

Human Medicinal Products


S/No:

176.

177.

178.

179.

180.

181.

182.

Registration Number

TAN 00,4526 R03A AST

TAN 00,2488 C06A AST

TAN 00,4182 C06A AST

TAN 05,140 G03H AST

TAN 06,244 C01E AST

TAN 06,245 C01E AST

TAN 06,358 J01K AST

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Pulmicort,Powder

Budesonide Ph Eur

200 mcg/dose

24

AstraZeneca AB.
SWEDEN

Atenolol Ph Eur

100 mg

60

AstraZeneca Ltd.
UNITED KINGDOM

Atenolol Ph Eur
Chlorthalidone Ph Eur

50 mg
12.5 mg

36

AstraZeneca Ltd.
UNITED KINGDOM

Bicalutamide BP

50 mg

60

Gorden Pharma GmBH


GERMANY

Candesartan Cilexetil IH

8 mg

36

AstraZeneca AB.
SWEDEN

Candesartan Cilexetil IH

16 mg

36

AstraZeneca AB.
SWEDEN

500 mg

48

Ternomin,Tablet

Tenoret,Tablet

Casodex,Tablet

Atacand,Tablet

Atacand,Tablet

Meronem IV,Powder for


Injection

Meropenem Trihydrate
equivalent to Anhydrous
Meropenem IH

Page 30 of 584

Sumitomo Pharmaceutical
Co.Ltd
JAPAN

Human Medicinal Products


S/No:

183.

184.

185.

186.

Registration Number

TAN 06,359 J01K AST

TAN 00,4186 L02B AST

TAN 00,4185 C06A AST

TAN 00,4064 P01B AST

Product Name
Pack and Pack size

Ingredient(s) and Strength

Meronem IV,Powder for


Injection

188.

TAN 00,4505 G03G AST

TZ11H005

Registrant

Manufacturer

Dainippon Sumitomo
Pharma Co.Ltd
JAPAN

Meropenem Trihydrate
equivalent to Anhydrous
Meropenem IH

1g

48

Anastrozole IH

1 mg

36

Atenolol Ph Eur

50 mg

60

AstraZeneca Ltd.
UNITED KINGDOM

36

AstraZeneca Ltd.
UNITED KINGDOM

AstraZeneca Ltd.
UNITED KINGDOM

Arimidex,Tablet
AstraZeneca
Pharmaceuticals LP
USA

Ternomin,Tablet

Paludrine,Tablet

Proguanil Hydrochloride Ph 100 mg


Eur

187.

Shelf life
month

Zoladex,Depot Injection

Goserelin Acetate NA

3.6 mg

36

Magnesium Trisilicate BP
Aluminium Hydroxide BP

250 mg
120 mg

36

Astacid,Tablets

AstraZeneca UK Limited - UNITED KINGDOM

Page 31 of 584

Astra Lifecare (India)


Pvt.Ltd
INDIA

Human Medicinal Products


S/No:

189.

Registration Number

TZ11H032

Product Name
Pack and Pack size

Ingredient(s) and Strength

TZ11H033

36

AstraZeneca Ltd.
UNITED KINGDOM

36

AstraZeneca Ltd.
UNITED KINGDOM

36

AstraZeneca Ltd.
UNITED KINGDOM

36

AstraZeneca Ltd.
UNITED KINGDOM

Pulmicort Nebuliser
Suspension
0.25mg/ml,Suspension

24

Astra Zeneka U.K. Ltd,


UNITED KINGDOM

Pulmicort Nebuliser
Suspension
0.5mg/ml,Suspension

36

Seroquel 100,Tablet

Quetiapine fumarate (None) 100 mg

191.

192.

193.

194.

195.

TZ11H034

TZ11H035

TZ11H022

TZ11H023

TZ11H024

Manufacturer

Seroquel 25,Tablet

Quetiapine fumarate (None) 25 mg

190.

Shelf life
month

Seroquel 200,Tablet

Seroquel 300,Tablet

Rhinocort Aqua 32
ug/dose,Nasal Spray

24

Page 32 of 584

Astra Export and Trading


AB
SWEDEN

AstraZeneca AB.
SWEDEN

Human Medicinal Products


S/No:

196.

197.

198.

199.

200.

Registration Number

TZ11H025

TZ11H028

TZ11H155

TZ11H029

TZ11H030

Registrant
201.

TAN 05,009 S01C ATC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Rhinocort Aqua 64
ug/dose,Nasal Spray

Shelf life
month

Manufacturer

24

AstraZeneca AB.
SWEDEN

36

AstraZeneca AB.
SWEDEN

36

AstraZeneca UK Limited
UNITED KINGDOM

36

AstraZeneca AB.
SWEDEN

36

AstraZeneca AB.
SWEDEN

Betaloc Zok 25mg,Tablet

Betaloc Zok 50mg,Tablet

Betaloc Zok 100mg,Tablet

Betaloc Zok 200mg,Tablet

ATCO Laboratories (PVT) Ltd. - PAKISTAN


Betaderm NM,Cream
0.5 %w/w
Neomycin Sulphate BP
Betamethasone Valerate BP 0.1 %w/w
2 %w/w
Miconazole Nitrate USP

Page 33 of 584

24

ATCO Laboratories (PVT)


Ltd.
PAKISTAN

Human Medicinal Products


S/No:

202.

203.

204.

205.

206.

207.

208.

Registration Number

TAN 05,010 M01A ATC

TAN 05,008 D07C ATC

TAN 06,360 J01K ATC

TAN 07,005 D01A ATC

TAN 07,006 N04C ATC

TAN 07,125 D07A ATC

TAN 05,009 S01C ATC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Ascard,Tablet

Acetylsalicylic Acid BP/USP 75 mg

36

Betamethasone Sodium
Phosphate BP
Neomycin Sulphate BP

105 g/100ml

24

Ubidecarenone (Coenzyme
Q10) USP

0.3 mg/ml

36

Ribavirin USP

400 mg

24

Bromazepam USP

3 mg

60

Clobetasol Propionate BP

0.05 g/100g

24

ATCO Laboratories (PVT)


Ltd.
PAKISTAN

Probeta N,Solution

0.525 g/100ml

ATCO Laboratories (PVT)


Ltd.
PAKISTAN

Bracin,Solution
ATCO Laboratories (PVT)
Ltd.
PAKISTAN

Virex,Capsules
ATCO Laboratories (PVT)
Ltd.
PAKISTAN

Anxit,Tablet
ATCO Laboratories (PVT)
Ltd.
PAKISTAN

Clobederm,Cream
ATCO Laboratories (PVT)
Ltd.
PAKISTAN

Betaderm NM,Cream
0.5 %w/w
Neomycin Sulphate BP
Betamethasone Valerate BP 0.1 %w/w
2 %w/w
Miconazole Nitrate USP

Page 34 of 584

24

ATCO Laboratories (PVT)


Ltd.
PAKISTAN

Human Medicinal Products


S/No:

209.

210.

211.

212.

213.

214.

Registration Number

TAN 05,009 S01C ATC

TAN 05,010 M01A ATC

TAN 05,010 M01A ATC

TAN 05,008 D07C ATC

TAN 05,008 D07C ATC

TAN 08,115 N04C ATC

Registrant

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Betaderm NM,Cream
0.5 %w/w
Neomycin Sulphate BP
Betamethasone Valerate BP 0.1 %w/w
2 %w/w
Miconazole Nitrate USP

24

Acetylsalicylic Acid BP/USP 75 mg

36

Acetylsalicylic Acid BP/USP 75 mg

36

Betamethasone Sodium
Phosphate BP
Neomycin Sulphate BP

105 g/100ml

24

Betamethasone Sodium
Phosphate BP
Neomycin Sulphate BP

105 g/100ml

Lorazepam BP

2 mg

ATCO Laboratories (PVT)


Ltd.
PAKISTAN

Ascard,Tablet
ATCO Laboratories (PVT)
Ltd.
PAKISTAN

Ascard,Tablet
ATCO Laboratories (PVT)
Ltd.
PAKISTAN

Probeta N,Solution

0.525 g/100ml

ATCO Laboratories (PVT)


Ltd.
PAKISTAN

Probeta N,Solution
24

0.525 g/100ml

ATCO Laboratories (PVT)


Ltd.
PAKISTAN

Tenzil,Tablet

Aurochem Laboratories Pvt. Ltd. - INDIA

Page 35 of 584

36

ATCO Laboratories (PVT)


Ltd.
PAKISTAN

Human Medicinal Products


S/No:

Registration Number

215.

TAN 00,2391 M01A PHD

Product Name
Pack and Pack size

Ingredient(s) and Strength

217.

218.

219.

220.

221.

TAN 00,2380 R03A PHD

TAN 09,318 A02B PHD

TAN 00,2607 J01F PHD

TAN 00,2606 M05A PHD

TAN 00,2616 A02B PHD

TAN 00,4152 R05A PHD

Manufacturer

Pixipham,Capsules

Piroxicam BP

216.

Shelf life
month

20 mg

36

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Ventopham,Tablet

Salbutamol Sulphate eq
4.803 mg
Salbutamol BP
Salbutamol Sulphate
4 mg
equivalent to Salbutamol BP

48

Cimetidine BP

36

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Tegapham,Tablet
400 mg

Aurochem Laboratories
Pvt. Ltd.
INDIA

Erythropham,Suspension

Erythromycin Estolate USP 100 mg/5ml

48

Mefanamic Acid BP

250 mg

36

Omeprazole USP

20 mg

24

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Meflam,Capsules
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Ulcer X,Capsules

Cold Off,Syrup

Page 36 of 584

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Human Medicinal Products


S/No:

222.

223.

Registration Number

TAN 00,2622 A11E PHD

TAN 00,2609 D01A PHD

Product Name
Pack and Pack size

Ingredient(s) and Strength

Chlorpheniramine Maleate
BP
Menthol BP
Paracetamol BP
Phenylephrine
Hydrochloride BP

2 mg/5ml

Thiamine Hydrochloride BP
Folic Acid BP
Zinc Sulphate BP
Ferric Ammonium Citrate
BP
Riboflavine BP
Riboflavine BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Cyanocobalamine BP

1 mg/5ml
0.25 mg/5ml
5 mg/5ml
200 mg/5ml

TAN 00,1766 DO1A AUC

TAN 00,2389 M01A PHD

0.1 mg/5ml
125 mg/5ml
2.5 mg/5ml

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

24

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

1.0 mg/5ml
0.002 mg/5ml
0.5 mg/5ml
0.002 mg/5ml

Whitefield,Ointment
6%
3%

36

100 mg

36

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Kandicide V,Pessaries

Clotrimazole USP

225.

36

Manufacturer

Globin Z,Syrup

Benzoic Acid BP
Salicylic Acid BP

224.

Shelf life
month

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Diclopham,Gel

Diclofenac Diethylamine BP 11.830 mg


1.01 mg
Menthol BP
50 mg
Diclofenac Sodium BP

Page 37 of 584

48

Aurochem Pharmaceuticals
(I) Pvt. Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

226.

TAN 00,2376 R03A PHD

Product Name
Pack and Pack size

Ingredient(s) and Strength

228.

229.

230.

231.

TAN 00,2377 A02A PHD

TAN 00,2378 D04A PHD

TAN 00,2382 D04A PHD

TAN 00,2621 P01B PHD

TAN 00,2608 P02X PHD

Manufacturer

Aminopham,Tablet

Aminophylline BP

227.

Shelf life
month

100 mg

24

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Magpham,Tablet

Dried Aluminium Hydroxide 354.950 mg


BP
Magnesium Trisilicate BP 250 mg
Aluminium Hdroxide Gel
120 mg
equivalent to Aluminium
Hydroxide BP

36

Promethazine Hydrochloride 25 mg
BP

48

Cyproheptadine
Hydrochloride BP

2 mg/5ml

36

Amodiaquine BP

50 mg/5ml

36

Mebendazole BP

100 mg/0.5ml

36

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Phamazine,Tablet
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Phamactin,Syrup
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Amoquin,Oral Suspension
Aurochem Pharmaceuticals
(I) Pvt. Ltd
INDIA

Wormnil,Tablet

Page 38 of 584

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

232.

TAN 00,2617 C06A PHD

Product Name
Pack and Pack size

Ingredient(s) and Strength

234.

235.

236.

237.

TAN 00,2613 A02A PHD

TAN 00,2614 P01A PHD

TAN 00,2619 A02B PHD

TAN 00,4154 D07C PHD

TAN 00,4155 M01A PHD

Manufacturer

Tensinol,Tablet
40 mg

48

Magnesium Hydroxide IHS


Aluminium Hydroxide IHS
Aluminium Hydroxide wet
gel equivalent to dried
Aluminium Hydroxide gel
BP
Magnesium Hydrochloride
BP

1000 mg/5ml
1500 mg/5ml
200 mg/5ml

36

Tinidazole BP

500 mg

36

Ranitidine Hydrochloride
BP

150 mg

36

Betamethasone BP
Tolnaftate BP
Gentamycin Sulphate BP
Betamethasone Valerate BP
Clioquinol BP

0.1 %w/v
10 mg
2 mg
0.51 mg
10 mg

36

Propranolol Hydrochloride
BP

233.

Shelf life
month

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Altapham,Suspension
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

200 mg/5ml

Phamazole,Tablet
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Phamatac,Tablet
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Trioderm,Cream
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Diclopham,Gel

Diclofenac Diethylamine BP 1.16 %

Page 39 of 584

36

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Human Medicinal Products


S/No:

238.

239.

240.

241.

Registration Number

TAN 00,4492 P02X PHD

TAN 05,679 M01A PHD

TAN 00,2606 M05A PHD

TAN 00,2606 M05A PHD

Registrant
242.

TAN 00,409 J01H AUR

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 00,502 J01C AUR

Manufacturer

Wormnil,Suspension

Mebendazole USP

100 mg

36

Ibuprofen BP

400 mg

36

Mefanamic Acid BP

250 mg

36

Mefanamic Acid BP

250 mg

36

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Ibupar,Tablet
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Meflam,Capsules
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Meflam,Capsules
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Aurochem Pharmaceuticals (India) Pvt. Ltd. - INDIA


Cloxil,Capsules

Cloxacillin Sodium eq
Cloxacillin BP

243.

Shelf life
month

250 mg

24

Aurobindo Pharma Limited


INDIA

24

Aurobindo Pharma Limited


INDIA

Z mox,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

Page 40 of 584

Human Medicinal Products


S/No:

244.

Registration Number

TAN 00,503 J01C AUR

Product Name
Pack and Pack size

Ingredient(s) and Strength

246.

247.

248.

249.

250.

TAN 00,521 J01F AUR

TAN 00,522 J01C AUR

TAN 00,523 A02B AUR

TAN 00,525 R05E AUR

TAN 00,525 R05E AUR

TAN 00,614 J01H AUR

Manufacturer

Z Cil,Suspension
125 mg/5ml

24

Aurobindo Pharma Limited


INDIA

Ampicillin Sodium
equivalent to Ampicillin BP

500 mg

24

Aurobindo Pharma Limited


INDIA

Cefalexin Monohydrate
equivalent to Cefalexin BP

250 mg

24

Aurobindo Pharma Limited


INDIA

Omeprazole BP

20 mg

24

Aurobindo Pharma Limited


INDIA

Chlorpheniramine Maleate
BP
Phenylpropanolamine
Hydrochloride BP

8 mg

36

Aurobindo Pharma Limited


INDIA

Chlorpheniramine Maleate
BP
Phenylpropanolamine
Hydrochloride BP

8 mg

36

Hilton Pharma (PVT) Ltd.


PAKISTAN

24

Aurobindo Pharma Limited


INDIA

Ampicillin Trihydrate
equivalent to Ampicillin IH

245.

Shelf life
month

Z Cil,Powder for Injection

Aurocef,Capsules

Zolcer,Capsules

Coldaur,Capsules

50 mg

Coldaur,Capsules

50 mg

Cloxil,Powder for Injection

Cloxacillin Sodium
500 mg
equivalent to Cloxacillin BP

Page 41 of 584

Human Medicinal Products


S/No:

251.

Registration Number

TAN 09,094 J01D AUR

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 09,095 J05A AUR

250 mg

24

Aurobindo Pharma Limited


INDIA

150 mg
200 mg
30 mg

24

Aurobindo Pharma Limited


INDIA

Ceftriaxone Sodium USP

1000 mg/vial

24

Lamivudine IH
Nevirapine IH
Stavudine IH

150 mg
200 mg
30 mg

24

Ampicillin Sodium
equivalent to Ampicillin BP

500 mg

24

Aurobindo Pharma Limited


INDIA

Ciprofloxacin USP

500 mg

36

Aurobindo Pharma Limited


INDIA

Zidovudine USP

300 mg

24

Stavudine + Lamivudine +
Nevirapine,Tablet

Lamivudine USP
Nevirapine USP
Stavudine USP

253.

254.

255.

256.

257.

TAN 00,4581 J01D AUR

TAN 00,4583 J05A AUR

TAN 00,521 J01F AUR

TAN 00,410 J01K AUR

TAN 05,725 J05A AUR

Manufacturer

Aurozil,Tablet

Cefprozil IH

252.

Shelf life
month

Triaxone,Powder for Injection


Aurobindo Pharma Ltd.Unit
VI Formulations
INDIA

Stavex-30LN,Tablet
Aurobindo Pharma Ltd.Unit
VI Formulations
INDIA

Z Cil,Powder for Injection

Recipro,Tablet

Zidovudine,Tablet

Page 42 of 584

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Human Medicinal Products


S/No:

258.

259.

260.

261.

262.

263.

264.

Registration Number

TAN 05,724 J05A AUR

TAN 05,726 J05A AUR

TAN 05,731 J05A AUR

TAN 05,727 J05A AUR

TAN 05,727 J05A AUR

TAN 05,728 J05A AUR

TAN 05,730 J05A AUR

Product Name
Pack and Pack size
Lamivudine +
Zidovudine,Tablet

Ingredient(s) and Strength

Shelf life
month

Lamivudine USP
Zidovudine USP

150 mg
300 mg

24

Lamivudine USP

300 mg

24

Lamivudine USP

300 mg

24

Nevirapine IH

200 mg

24

Nevirapine IH

200 mg

24

Lamivudine USP

300 mg

24

Lamivudine USP

150 mg

24

Manufacturer

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Lamivudine,Tablet
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Lamivudine,Tablet
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Nevirapine,Tablet
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Nevirapine,Tablet
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Lamivudine,Tablet
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Lamivudine,Tablet

Page 43 of 584

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Human Medicinal Products


S/No:

265.

Registration Number

Product Name
Pack and Pack size

TAN 05,729 J05A AUR

Stavudine,Capsules

Ingredient(s) and Strength

Stavudine USP

266.

267.

268.

269.

270.

TAN 00,407 J01H AUR

TAN 00,408 J01H AUR

TAN 00,411 J01H AUR

TAN 06,247 J05A AUR

TAN 06,347 J05A AUR

TAN 06,246 J05A AUR

24

Manufacturer

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Z mox,Capsules

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

36

Aurobindo Pharma Limited


INDIA

Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

36

Aurobindo Pharma Limited


INDIA

Ampicillin Trihydrate BP

250 mg

24

Aurobindo Pharma Limited


INDIA

Efavirenz IH

600 mg

24

50 mg/5ml

24

10 mg/ml

24

Zuclox,Capsules

Z Cil,Capsules

Efavirenz,Tablet
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Nevirapine,Suspension

Nevirapine USP

271.

30 mg

Shelf life
month

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Lamivudine,Solution

Lamivudine USP

Page 44 of 584

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Human Medicinal Products


S/No:

272.

273.

274.

275.

276.

Registration Number

TAN 06,362 J05A AUR

TAN 07,129 J05A AUR

TAN 07,127 J05A AUR

TAN 07,126 J05A AUR

TAN 07,128 J05A AUR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Lamivudine + Zidovudine +
Nevirapine,Solution

Stavudine +
Lamivudine,Tablet

Lamivudine USP
Nevirapine USP
Zidovudine USP

150 mg
200 mg
300 mg

24

Lamivudine USP
Stavudine USP

150 mg
40 mg

24

Abacavir Sulphate IH

100 mg

24

Lamivudine USP
Stavudine USP

150 mg
30 mg

24

600 mg
150 mg
300 mg

24

278.

TAN 07,134 J01D AUR

Cefadroxil Monohydrate BP 500 mg

24

TAN 07,135 J01D AUR

Manufacturer

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Abacavir,Tablet

Stavudine +
Lamivudine,Tablet

Lamivudine,Zidovudine +
Efavirenz,Tablet

Efavirenz IH
Lamivudine USP
Zidovudine USP

277.

Shelf life
month

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Drox,Capsules
Aurobindo Pharma Ltd.Unit
VI Formulations
INDIA

Auroxetil 500,Tablets

Cefuroxime Axetil Ph Eur

Page 45 of 584

500 mg

36

Aurobindo Pharma Ltd.Unit


VI Formulations
INDIA

Human Medicinal Products


S/No:

279.

Registration Number

TAN 07,137 J01C AUR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Koact 312.50,Powder for


Suspension

281.

282.

283.

284.

285.

TAN 07,136 J01C AUR

TAN 07,130 J01D AUR

TAN 08,027 J05A AUR

TAN 08,126 J01D AUR

TAN 00,525 R05E AUR

TAN 09,004 J05A AUR

Manufacturer

24

Aurobindo Pharma Ltd


INDIA

Amoxicillin Trihydrate eq to 125 mg/5ml


Amoxicillin Ph Eur
Potassium Clavulanate eq to 31.25 mg
Clavulanic Acid Ph Eur

24

Aurobindo Pharma Ltd


INDIA

Cefuroxime Axetil BP

250 mg

24

Efavirenz IH

100 mg

24

Cefprozil IH

250 mg/5ml

24

Chlorpheniramine Maleate
BP
Phenylpropanolamine
Hydrochloride BP

8 mg

36

Stavudine USP

20 mg

Potassium Clavulanate eq to 62.5 mg/ml


Clavulanic Acid Ph Eur
Amoxicillin Trihydrate eq to 250 mg/ml
Amoxicillin Ph Eur

280.

Shelf life
month

Koact 156.25,Powder for


Suspension

Cefuxime,Tablet
Aurobindo Pharma Ltd.Unit
VI Formulations
INDIA

Efavirenz,Capsules
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Aurozil,Syrup
Aurobindo Pharma Ltd.Unit
VI Formulations
INDIA

Coldaur,Capsules
Aurobindo Pharma Limited
INDIA

50 mg

Stavudine,Capsules

Page 46 of 584

24

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

Human Medicinal Products


S/No:

286.

Registration Number

TAN 10,005 J05A

Product Name
Pack and Pack size

Ingredient(s) and Strength

TZ10H003

289.

290.

291.

292.

TZ10H004

TAN 10,052 J05A

TZ10H072

TZ10H073

TZ10H074

Aurobindo Pharma Ltd.


Unit III Formulations
INDIA

100 mg

24

400 mg

24

Aurobindo Pharma Limited


INDIA

Didanosine USP

250 mg

24

Aurobindo Pharma Limited


INDIA

Stavudine USP

15 mg

24

Captopril Ph Eur

50 mg

36

Aurobindo Pharma Limited


INDIA

Captopril Ph Eur

12.5 mg

36

Aurobindo Pharma Limited


INDIA

Captopril Ph Eur

25 mg

36

Aurobindo Pharma Limited


INDIA

Didanosine Delayed Release


400,Capsules

Didanosine USP

288.

Manufacturer

Zidovudine,Capsules

Zidovudine USP

287.

Shelf life
month

Didanosine Delayed Release


250,Capsules

Stavudine,Capsules
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Taguar 50,Tablets

Taguar 12.5,Tablets

Taguar 25,Tablets

Page 47 of 584

Human Medicinal Products


S/No:

293.

294.

295.

Registration Number

TZ10H094

TAN 00,410 J01K AUR

TZ10H113

Product Name
Pack and Pack size
Emtricitabine +
Tenofovir,Tablets

Ingredient(s) and Strength

TZ10H121

Aurobindo Pharma Limited


INDIA

500 mg

36

Aurobindo Pharma Limited


INDIA

500 mg

36

Aurobindo Pharma Limited


INDIA

500 mg
4000 mg

24

Aurobindo Pharma Ltd


INDIA

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

36

Aurobindo Pharma Limited


INDIA

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

36

Aurobindo Pharma Limited


INDIA

Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

36

Aurobindo Pharma Limited


INDIA

300 mg

Ciprofloxacin Ph Eur

298.

299.

TAN 00,407 J01H AUR

TAN 00,407 J01H AUR

TAN 00,408 J01H AUR

200 mg

Recipro,Tablet

Auroxetil 500,Tablets

Aurotaz-P,Injectable Solution

Tazobactum Sodium IH
Piperacillin Sodium IH

297.

Manufacturer

24

Tenofovir Disoproxil
Fumarate IH
Emtricitabine IH

Cefuroxime Axetil Ph Eur

296.

Shelf life
month

Z mox,Capsules

Z mox,Capsules

Zuclox,Capsules

Page 48 of 584

Human Medicinal Products


S/No:

300.

301.

302.

303.

Registration Number

TAN 00,408 J01H AUR

TAN 00,411 J01H AUR

TAN 00,411 J01H AUR

TZ11H180

Product Name
Pack and Pack size

Ingredient(s) and Strength

TZ11H021

Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

36

Aurobindo Pharma Limited


INDIA

Ampicillin Trihydrate BP

250 mg

24

Aurobindo Pharma Limited


INDIA

Ampicillin Trihydrate BP

250 mg

24

Aurobindo Pharma Limited


INDIA

200 mg
50 mg

24

Aurobindo Pharma Limited


INDIA

300 mg

24

Matrix Laboratories Ltd


INDIA

500 mg

24

Bal Pharma Ltd


INDIA

Z Cil,Capsules

Z Cil,Capsules

Lopinavir & Ritonavir,Tablet

Tenofovir Disoproxil
Fumarate 300mg,Tablet

Tenofovir Disoproxil
Fumarate IH

Registrant
305.

TAN 07,440 J01K BAL

Manufacturer

Zuclox,Capsules

Lopinavir USP
Ritonavir USP

304.

Shelf life
month

Bal Pharma Ltd - INDIA


Ultraflox,Tablet

Ciprofloxacin USP

Page 49 of 584

Human Medicinal Products


S/No:

306.

307.

308.

Registration Number

TAN 07,608 B04A BAL

TZ11H002

TZ10H085

Registrant
309.

310.

TAN 00,4445 N02B BAR

TAN 05,144 C04A BAR

Registrant
311.

TAN 00,002 B05B WOC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Lipofix,Tablet

Atorvastatin Calcium IH

20 mg

24

Bal Pharma Ltd


INDIA

Fluconazole IH

200 mg/100ml

24

Bal Pharma Ltd


INDIA

Ketoconazole USP

200 mg

36

Bal Pharma Ltd


INDIA

Fungicon,Injection

Ketovate,Tablets

Barakat Pharmaceutical Industries - SYRIA


Paracetamol,Suppositories

Paracetamol BP

125 mg

36

Sildenafil Citrate IH

50 mg

36

5.0 %w/v

36

Barakat Pharmaceutical
Industries
SYRIA

Vaigran,Tablet
Barakat Pharmaceutical
Industries
SYRIA

Baxter (India) Pvt Ltd. - INDIA


Glucose IV,Solution

Dextrose Anhydrous BP

Registrant

Shelf life
month

Bayer East Africa Ltd. - KENYA


Page 50 of 584

Baxter (India) Pvt Ltd.


INDIA

Human Medicinal Products


S/No:

312.

313.

314.

315.

316.

Registration Number

TAN 09,098 J02A BAY

TAN 00,1124 G03A LRS

TAN 00,4218 G03A LEI

TZ10H020

TZ10H21

Product Name
Pack and Pack size

Ingredient(s) and Strength

318.

TZ10H023

TZ10H093

Manufacturer

Baycuten,Cream

Clotrimazole Ph Eur
Dexamethasone Ph Eur

1g
0.0443 g

36

Bayer Pharma
MOROCCO

Levonorgedtrel USP

36 mg

60

Bayer East Africa Ltd.


KENYA

Levonorgestrel IH

75 mg

24

Bayer East Africa Ltd.


KENYA

36

Bayer Healthcare AG
GERMANY

10 mg

36

Bayer Healthcare AG
GERMANY

Iopromide IH

769 mg/ml

36

Bayer Healthcare AG
GERMANY

Nimodipine Ph Eur

10 mg

36

Bayer Healthcare AG
GERMANY

Norplant,Implant

Jadelle,Implant

Mirena,Intra Uterine Device

Xarelto,Tablet

Rivaroxaban IH

317.

Shelf life
month

Ultravist 370,Solution for


Injection and Infusion

Nimotop,Injection

Page 51 of 584

Human Medicinal Products


S/No:

319.

Registration Number

TZ10H100

Product Name
Pack and Pack size

Ingredient(s) and Strength

TZ10H130

400 mg

36

Bayer Healthcare AG
GERMANY

370 mg

36

Bayer East Africa Ltd.


KENYA

Vardenafil Hydrochloride IH 10 mg

36

Bayer Healthcare AG
GERMANY

Vardenafil Hydrochloride IH 20 mg

36

Bayer Healthcare AG
GERMANY

60 mg

60

Bayer Healthcare AG
GERMANY

Vardenafil Hydrochloride IH 10 mg

36

Bayer Healthcare AG
GERMANY

Ultravist 370,Solution for


Injection and Infusion

Iopromide Ph Eur

Registrant
321.

322.

323.

TAN 00,4528 C04A BAY

TAN 00,4529 C04A BAY

TAN 00,630 J01K BAY

Bayer Healthcare AG - GERMANY


Levitra,Tablet

Levitra,Tablet

Rantudil Forte,Capsules

Acematacin IH

324.

TAN 00,4528 C04A BAY

Manufacturer

Ciprobay IV,Solution

Ciprofloxacin Lactate USP

320.

Shelf life
month

Levitra,Tablet

Page 52 of 584

Human Medicinal Products


S/No:

325.

326.

327.

328.

329.

330.

331.

Registration Number

TAN 05,465 J01K BAY

TAN 06,250 J01K BAY

TAN 00,623 J01K BAY

TAN 00,4527 C04A BAY

TAN 00,4529 C04A BAY

TAN 05,465 J01K BAY

TAN 05,465 J01K BAY

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Avelon,Solution

Moxifloxacin Hydrochloride 400 mg


IH

36

Bayer Healthcare AG
GERMANY

Ciprofloxacin BP

500 mg

24

Bayer Healthcare AG
GERMANY

Ciprofloxacin Lactate BP

200 mg/100ml

60

Bayer Healthcare AG
GERMANY

Vardenafil Hydrochloride IH 5 mg

36

Bayer Healthcare AG
GERMANY

Vardenafil Hydrochloride IH 20 mg

36

Bayer Healthcare AG
GERMANY

Moxifloxacin Hydrochloride 400 mg


IH

36

Bayer Healthcare AG
GERMANY

Moxifloxacin Hydrochloride 400 mg


IH

36

Bayer Healthcare AG
GERMANY

Ciprobay XR,Tablet

Ciprobay,Solution

Levitra,Tablet

Levitra,Tablet

Avelon,Solution

Avelon,Solution

Page 53 of 584

Human Medicinal Products


S/No:

332.

333.

Registration Number

TAN 00,4527 C04A BAY

TAN 00,4527 C04A BAY

Registrant
334.

335.

336.

337.

TAN 06,021 J01H BEI

TAN 06,019 J01D BEI

TAN 06,020 A02B BEI

TZ10H114

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Levitra,Tablet

Vardenafil Hydrochloride IH 5 mg

36

Bayer Healthcare AG
GERMANY

Vardenafil Hydrochloride IH 5 mg

36

Bayer Healthcare AG
GERMANY

Levitra,Tablet

Beijing Holley Cotec Pharmaceutical Co.Ltd - CHINA


Amoxycillin,Capsules

Amoxycillin Trihydrate IH

250 mg

24

Cefradine IH

250 mg

24

Omeprazole IH

20 mg

18

20 mg
160 mg

24

Zhejiang Holley Nanhu


Pharmaceutical Co. Ltd
CHINA

Cefradine,Capsules
Zhejiang Holley Nanhu
Pharmaceutical Co. Ltd
CHINA

Omeprazole,Tablet
Zhejiang Holley Nanhu
Pharmaceutical Co. Ltd
CHINA

Duo-Cotexin,Tablets

Dihydroartemisinin IH
Piperaquine Phosphate IH

Registrant

Shelf life
month

Bell Sons & Co (Druggists) Ltd. - UNITED KINGDOM

Page 54 of 584

Zhejiang Holley Nanhu


Pharmaceutical Co. Ltd
CHINA

Human Medicinal Products


S/No:

338.

Registration Number

TAN 07,142 A06A BET

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 07,141 V03A BET

Silver Bird Eucalyptus


Oil,Solution

Eucalyptus Oil BP

Registrant
340.

TAN 09,043 N02B E.D

341.

342.

343.

TAN 00,533 A02A BEH

TAN 00,1551 N02B BEH

TAN 09,101 N02B BET

100 %v/v

24

100 %v/v

24

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Bene Avzneimittel GmbH - GERMANY


Para-Denk 500,Tablet

Paracetamol BP/Ph.Eur

Registrant

Manufacturer

Liquid paraffin,Solution

Liquid Paraffin BP

339.

Shelf life
month

500 mg

60

Bene Avzneimittel GmbH


GERMANY

Beta Healthcare International Ltd. - KENYA


Woodwards Gripe
water,Solution

Terpeneless Dill Seed Oil BP 2.15 mg


0.36 ml
Ginger Tincture BP
Sodium Bicarbonate Ph Eur 50 mg

24

Ibuprofen BP

100 mg/5ml

24

Caffeine BP
Paracetamol BP
Acetylsalicylic Acid BP

50 mg
400 mg
200 mg

60

Beta Healthcare
International Ltd.
KENYA

Betafen,Syrup
Beta Healthcare
International Ltd.
KENYA

Femme,Tablet

Page 55 of 584

Beta Healthcare
International Ltd.
KENYA

Human Medicinal Products


S/No:

344.

345.

346.

347.

348.

Registration Number

TAN 00,4065 P01A BET

TAN 09,039 A02A BET

TAN 05,012 P01A BET

TAN 00,076 M02A BEH

TAN 00,077 R05F BEH

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Betrozole,Suspension

Metronidazole Benzoate BP 160 mg/5ml


125 mg/5ml
Diloxanide Furoate BP
25 mg/5ml
Simethicone USP

36

Magnesium Hydroxide BP
Simethicone BP
Aluminium Hydroxide BP
Magnesium Aluminium
Silicate BP

25 mg
25 mg
300 mg
50 mg

36

Diloxanide Furoate BP
Metronidazole BP

250 mg
200 mg

24

Camphor Synthetic BP
Turpentine Oil BP
Methyl Salicylate BP
Strong Ammonia Solution
BP
Methylated Spirit BP
Camphor oil BPC
Capsicum Oleoresin BPC

2 g/100ml
25 ml/100ml
5 ml/100ml
0.12 ml/100ml

36

Beta Healthcare
International Ltd.
KENYA

Betacid,Tablet
Beta Healthcare
International Ltd.
KENYA

Betrozole,Tablet
Beta Healthcare
International Ltd.
KENYA

Salimia,Liniment
Beta Healthcare
International Ltd.
KENYA

72.5 ml/100ml
1 ml/100ml
0.22 g/100ml

Goodmorning Cough,Tablet

Eucalyptus Oil BP
Menthol BP
Liquorice BP
Peppermint BP
Creosote BPC
Tolu BPC
Capsicum BPC

Page 56 of 584

2.2 mg
11.25 mg
56.35 mg
1.1 ml
2.2 mg
0.04 ml
0.03 ml

36

Beta Healthcare
International Ltd.
KENYA

Human Medicinal Products


S/No:

349.

350.

351.

352.

353.

354.

355.

Registration Number

TAN 00,078 R05F BEH

TAN 00,079 P03A BEH

TAN 00,483 A02A BEH

TAN 00,536 N02B BEH

TAN 07,269 N02B BET

TAN 07,270 N02B BET

TAN 00,297 N02B BEH

Product Name
Pack and Pack size
Goodmorning Lung
tonic,Syrup

Ingredient(s) and Strength

Shelf life
month

Anise Oil BPC


Liquorice BPC
Creostum BPC
Liquid tolu BPC
Tincture of Capsicum BPC

13.89 mg/5ml
25 mg/5ml
66.65 mg/5ml
0.56 mg/5ml
0.25 ml

36

Benzyl benzoate BP

25 %w/v

36

Dill Oil BP
Sodium Bicarbonate BP

2.15 mg/5ml
50 mg/5ml

36

Acetylsalicylic Acid BP

300 mg

48

Paracetamol BP

500 mg

36

Paracetamol BP

120 mg/5ml

36

Caffeine Anhydrous BP
Paracetamol BP
Acetylsalicylic Acid BP

50 mg
200 mg
400 mg

36

Manufacturer

Beta Healthcare
International Ltd.
KENYA

Opele,Lotion
Beta Healthcare
International Ltd.
KENYA

Beta Gripe water,Solution


Beta Healthcare
International Ltd.
KENYA

Aspirin,Tablet
Beta Healthcare
International Ltd.
KENYA

Feverex,Tablet
Beta Healthcare
International Ltd.
KENYA

Feverex Toto,Suspension
Beta Healthcare
International Ltd.
KENYA

Maramol,Tablet

Page 57 of 584

Beta Healthcare
International Ltd.
KENYA

Human Medicinal Products


S/No:

356.

357.

358.

359.

360.

Registration Number

TAN 09,039 A02A BET

TAN 00,076 M02A BEH

TAN 00,077 R05F BEH

TAN 00,078 R05F BEH

TAN 00,079 P03A BEH

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Betacid,Tablet

Magnesium Hydroxide BP
Simethicone BP
Aluminium Hydroxide BP
Magnesium Aluminium
Silicate BP

25 mg
25 mg
300 mg
50 mg

36

Camphor Synthetic BP
Turpentine Oil BP
Methyl Salicylate BP
Strong Ammonia Solution
BP
Methylated Spirit BP
Camphor oil BPC
Capsicum Oleoresin BPC

2 g/100ml
25 ml/100ml
5 ml/100ml
0.12 ml/100ml

36

Beta Healthcare
International Ltd.
KENYA

Salimia,Liniment
Beta Healthcare
International Ltd.
KENYA

72.5 ml/100ml
1 ml/100ml
0.22 g/100ml

Goodmorning Cough,Tablet

Goodmorning Lung
tonic,Syrup

Eucalyptus Oil BP
Menthol BP
Liquorice BP
Peppermint BP
Creosote BPC
Tolu BPC
Capsicum BPC

2.2 mg
11.25 mg
56.35 mg
1.1 ml
2.2 mg
0.04 ml
0.03 ml

36

Anise Oil BPC


Liquorice BPC
Creostum BPC
Liquid tolu BPC
Tincture of Capsicum BPC

13.89 mg/5ml
25 mg/5ml
66.65 mg/5ml
0.56 mg/5ml
0.25 ml

36

Benzyl benzoate BP

25 %w/v

36

Beta Healthcare
International Ltd.
KENYA

Beta Healthcare
International Ltd.
KENYA

Opele,Lotion

Page 58 of 584

Beta Healthcare
International Ltd.
KENYA

Human Medicinal Products


S/No:

361.

362.

363.

Registration Number

TAN 00,483 A02A BEH

TAN 00,536 N02B BEH

TAN 00,533 A02A BEH

Registrant
364.

TAN 09,102 A01A BET

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,067 R02A BET

Manufacturer

Beta Gripe water,Solution

Dill Oil BP
Sodium Bicarbonate BP

2.15 mg/5ml
50 mg/5ml

36

Acetylsalicylic Acid BP

300 mg

48

Beta Healthcare
International Ltd.
KENYA

Aspirin,Tablet

Woodwards Gripe
water,Solution

50 mg
Sodium Bicarbonate BP
2.15 mg/5ml
Dill Oil Terpeneless BP
Terpeneless Dill Seed Oil BP 2.15 mg

24

Beta Healthcare
International Ltd.
KENYA

Beta Healthcare
International Ltd.
KENYA

Beta Pharmaceuticals - UNITED KINGDOM


Toothache,Tincture

Levomenthol BP
Clove Oil BP
Phenol BP
365.

Shelf life
month

2 %w/v
7.5 %w/v
1 %w/v

24

11.55 %w/w
0.79 %w/w
1.98 %w/w
0.79 %w/w

36

0.49 %w/w
0.36 %w/w

24

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Menthodex,Ointment

Camphor racemic BP
Eucalyptus Oil BP
Levomenthol BP
Methyl Salicylate

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Methyl Salicylate BP
366.

TAN 00,4389 R02A BET

Menthodex,Lozenges

Eucalyptus Oil BP
Levomenthol BP

Page 59 of 584

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

367.

Registration Number

TAN 05,147 M02A BET

Product Name
Pack and Pack size

Ingredient(s) and Strength

369.

370.

TAN 05,466 D11A BET

TAN 05,580 M01A BET

TAN 05,579 V07A BET

12.5 %v/v

36

Levomenthol BP
Camphor racemic BP
Eucalyptus Oil BP

5.5 %w/v
2.8 %w/v
1.4 %w/v

36

Methyl Salicylate

15 %w/w

36

Methyl Salicylate BP
Capsicum Oleoresin BP

0.56 %w/w

372.

TAN 05,737 BET

TAN 05,738 D08A BET

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Vapour Rub,Ointment

Baboo Medicated
Rub,Ointment

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Kilkof,Solution
2 %v/v
Ipecacuanha Tincture BP
Cetylpyridinium Chloride BP 0.03 %w/v
0.44 %v/v
Capsicum tincture BP
1.66 %v/v
Benzoin tincture BP

371.

Manufacturer

Nerve and Bone,Liniment

Turpentine Oil BP

368.

Shelf life
month

36

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Children Cough Syrup,Syrup

Guaiphenesin BP

2 %w/v

36

Cetrimide BP

0.5 %w/w

24

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Cetrimide,Cream

Page 60 of 584

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

373.

374.

375.

376.

377.

Registration Number

TAN 05,739 V07A BET

TAN 06,131 V07A BET

TAN 06,130 V07A BET

TAN 05,092 D04A BET

TAN 00,1357 A02A BET

Product Name
Pack and Pack size

Ingredient(s) and Strength

378.

TZ10H115

Sweet birch oil BPC

0.12 %w/v

24

Lanolin BP
Zinc (as Zinc Oxide) BP
Castor oil BP

4 %w/w
7.5 %w/w
4.5 %w/w

60

Arachis Oil BP
Nutmeg Oil BP
Eucalyptus BP
Terpineol BP

90.1 %v/v
0.4 %v/v
7.5 %v/v
2 %v/v

24

Zinc Oxide BP
Calamine BP

15 %w/v
5 %w/v

36

2.4 %w/v

48

Bell Sons & Co (Druggists)


Ltd.
UNITED KINGDOM

Zincast,Cream
Bell Sons & Co (Druggists)
Ltd.
UNITED KINGDOM

Nowax,Solution
Bell Sons & Co (Druggists)
Ltd.
UNITED KINGDOM

Calamine,Lotion
Bell Sons & Co (Druggists)
Ltd.
UNITED KINGDOM

Paracetamol,Solution
Bell Sons & Co (Druggists)
Ltd.
UNITED KINGDOM

Bharat Serums and Vaccines Ltd. - INDIA


Propavan,Injection

Propofol BP

Registrant

Manufacturer

Muscle Rub,Ointment

Paracetamol BP

Registrant

Shelf life
month

10 mg/ml

Bilim Pharmaceuticals A.S, - TURKEY

Page 61 of 584

24

Bharat Serums and


Vaccines Ltd
INDIA

Human Medicinal Products


S/No:

379.

Registration Number

TAN 05,746 J01D BIL

Product Name
Pack and Pack size

Ingredient(s) and Strength

381.

382.

383.

384.

TAN 05,749 J01C BIL

TAN 05,750 J01C BIL

TAN 05,744 J01C BIL

TAN 05,747 J02A BIL

TAN 05,748 J02A BIL

Manufacturer

Cetafor,Powder for Injection


36

Bilim Pharmaceuticals A.S,


TURKEY

Potassium Clavulanate eq to 28.5 mg/ml


Clavulanic Acid Ph Eur
Amoxicillin Trihydrate
200 mg/5ml
equivalent to Amoxicillin Ph
Eur

24

Bilim Pharmaceticals A.S,


TURKEY

Clavulanate Potassium Ph 125 mg


Eur
Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin Ph
Eur

24

Bilim Pharmaceticals A.S,


TURKEY

Clavulanate Potassium Ph 31.25 mg/5ml


Eur
Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin Ph
Eur

24

Bilim Pharmaceticals A.S,


TURKEY

Ketoconazole Ph Eur

2 %w/w

24

Bilim Pharmaceutials A.S


TURKEY

Ketoconazole Ph Eur

200 mg

24

Bilim Pharmaceutials A.S


TURKEY

Ceftriaxone Disodium Ph
Eur
Ceftriaxone Disodium
Trihydrate equivalent to
Ceftriaxone Ph Eur
380.

Shelf life
month

500 mg
500 mg/vial

Klamoks,Dry Powder

Klamoks,Tablet

Klamoks,Powder for
Suspension

Ketoral,Cream

Ketoral,Tablet

Page 62 of 584

Human Medicinal Products


S/No:

385.

Registration Number

TAN 05,743 J02A BIL

Product Name
Pack and Pack size

Ingredient(s) and Strength

386.

TAN 09,269 J07A BIO

2 g/100ml

387.

388.

389.

390.

TAN 00,1555 J01K BLU

TAN 00,1769 A03D BLU

TAN 00,1558 D07X BLU

TAN 00,1961 M01A BLU

24

Bilim Pharmaceticals A.S,


TURKEY

Biovac S. A (Pty) Ltd. - SOUTH AFRICA


Rabipur,Freeze dried powder
for reconstitution

Inactivated Rabies Virus Ph 2.5 IU


Eur

Registrant

Manufacturer

Ketoral,Shampoo

Ketoconazole Ph Eur

Registrant

Shelf life
month

48

Chiron Behring Vaccines


Private Ltd.
INDIA

Blue Cross Laboratories Ltd. - INDIA


Bluspar,Tablet
Blue Cross Laboratories
Ltd.
INDIA

Sparfloxacin IH

200 mg

24

Dicyclomine Hydrochloride
BP
Mefanamic Acid BP

10 mg

36

Blue Cross Laboratories Ltd


INDIA

Meftal Spas,Tablet

250 mg

Sonaderm GM,Cream

Clobetasol Propionate BP
Miconazole Nitrate BP
Chlorocresol BP
Gentamicin BP

0.05 %w/w
0.2 %w/w
0.1 %w/w
0.1 %w/w

24

Blue Cross Laboratories Ltd


INDIA

Mefanamic Acid BP

250 mg

36

Blue Cross Laboratories Ltd


INDIA

Meftal,Tablet

Page 63 of 584

Human Medicinal Products


S/No:

Registration Number

391.

TAN 00,2110 R05D BLU

392.

393.

TAN 00,2110 R05D BLU

TZ10H095

Product Name
Pack and Pack size

Ingredient(s) and Strength

394.

TAN 06,253 N04A BOD

Phenylpropanolamine
Hydrochloride USP
Dextromethorphan
Hydrobromide BP
Chlorpheniramine Maleate
BP

1.25 mg/5ml

Phenylpropanolamine
Hydrochloride USP
Dextromethorphan
Hydrobromide BP
Chlorpheniramine Maleate
BP

1.25 mg/5ml

TAN 06,254 B01A BOD

TAN 06,252 B01A BOD

Blue Cross Laboratories


Ltd.
INDIA

2 mg/5ml

Tusq D,Suspension
18

10 mg/5ml

Blue Cross Laboratories


Ltd.
INDIA

2 mg/5ml

Meftal Forte,Tablets
500 mg
450 mg

36

Blue Cross Laboratories Ltd


INDIA

Bodene (PTY) Ltd trading as Intramed, - SOUTH AFRICA


Suxamethonium
chloride,Injectable Solution

Heparin Sodium,Injectable
Solution

Heparin Sodium Ph Eur

396.

18

10 mg/5ml

Suxamethonium Chloride IH 100 mg/2ml

395.

Manufacturer

Tusq D,Suspension

Mefenamic Acid BP
Paracetamol BP

Registrant

Shelf life
month

Heparin Sodium,Injectable
Solution

Heparin Sodium Ph Eur

Page 64 of 584

18

1000 IU/ml

36

5000 IU/ml

24

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Human Medicinal Products


S/No:

397.

Registration Number

TAN 06,255 N06A BOD

Product Name
Pack and Pack size

Ingredient(s) and Strength

Neostigmine,Injectable
Solution

Neostigmine Methyl
Sulphate BP

398.

TAN 06,256 G02A BOD

Ergometrine
Maleate,Injectable Solution

Ergometrine Maleate BP

399.

TAN 06,366 N02A BOD

2.5 mg/ml

36

0.5 mg/5ml

18

Pethidine Hcl- Fresenius


PF,Injectable Solution

Pethidine Hydrochloride Ph 50 mg/ml


Eur

400.

TAN 06,365 N02A BOD

Pethidine Hcl- Fresenius


PF,Injectable Solution

Pethidine Hydrochloride Ph 100 mg/2ml


Eur

401.

TAN 06,364 V03A BOD

Morphine Sulphate- Fresenius


PF,Injectable Solution

Morphine Sulphate Ph Eur

402.

TAN 06,363 V03A BOD

Morphine Sulphate- Fresenius


PF,Injectable Solution

Morphine Sulphate Ph Eur

Registrant

60

60

10 mg/ml

30

15 mg/ml

30

Boehringer Ingelheim Pharma KG. - GERMANY

Page 65 of 584

Shelf life
month

Manufacturer

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Human Medicinal Products


S/No:

403.

Registration Number

TAN 00,977 J05A BHI

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 00,1365 J05A BHI

405.

TAN 06,369 D08A BRO

407.

TZ10H077

TZ11H178

Registrant
408.

TAN 09,106 J01F BRO

24

50 mg/5ml

24

Boehringer Ingelheim
Pharma KG.
GERMANY

Roxane Laboratories Inc.


USA

Brookes Pharmaceuticals Laboratories(Pakistan) Ltd. - PAKISTAN


Pyodine,Solution
10 g/100ml

24

Povidone Iodine USP

7.5 w/v

36

Amlodipine Besylate BP

10 mg

36

Povidone Iodine BP

406.

200 mg

Viramune,Suspension

Nevirapine IH

Registrant

Manufacturer

Viramune,Tablet

Nevirapine IH

404.

Shelf life
month

Brookes Pharmaceuticals
Laboratories(Pakistan) Ltd.
PAKISTAN

Pyodine Sugical Scrub,Liquid


Brookes Pharmaceuticals
Laboratories(Pakistan) Ltd.
PAKISTAN

Coram,Tablet
Brookes Pharmaceuticals
Laboratories(Pakistan) Ltd.
PAKISTAN

Brown & Burk Pharmaceuticals Ltd. - INDIA


Clariwin,Tablet

Clarithromycin USP

Page 66 of 584

250 mg

24

Brown & Burk


Pharmaceuticals Ltd
INDIA

Human Medicinal Products


S/No:

409.

410.

Registration Number

TAN 05,584 J02A BRO

TAN 07,445 J01C BRO

Registrant
411.

412.

TAN 09,271 C04A CAD

TAN 09,270 C04A CAD

Registrant
413.

TAN 00,250 A02B CAH

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 07,143 A02B CAD

Manufacturer

Phytoral,Tablet
Brown & Burk
Pharmaceuticals Ltd
INDIA

Ketoconazole USP

200 mg

36

Amoxycillin BP
Cloxacillin BP

250 mg
250 mg

24

Sildenafil (as Citrate) IH

100 mg

24

Cadila Healthcare Ltd.


INDIA

Sildenafil (as Citrate) IH

50 mg

24

Cadila Healthcare Ltd.


INDIA

150 mg

36

Cadila Healthcare Ltd.


INDIA

20 mg

18

Cadila Pharmaceuticals Ltd


INDIA

Cloxap,Capsules
Brown & Bulk
Pharmaceutical Ltd
INDIA

Cadila Health Care Ltd. - INDIA


Penagra,Tablet

Penagra,Tablet

Cadila Healthcare Ltd. - INDIA


R Loc,Tablet

Ranitidine Hydrochloride
USP

414.

Shelf life
month

Rabeloc,Injectable Solution

Rabeprazole Sodium IH

Page 67 of 584

Human Medicinal Products


S/No:

415.

416.

417.

418.

419.

Registration Number

TAN 07,274 A02B CAD

TAN 00,645 C01C CAH

TAN 00,637 D06A CAH

TAN 00,642 C01C CAH

TAN 00,643 A10B CAH

Registrant
420.

TAN 00,233 J01G CAP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Rabeloc 20,Tablet

Rabeprazole Sodium IH

20 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Atenolol BP

50 mg

36

Cadila Healthcare Ltd.


INDIA

Neomycin Sulphate BP
Dexamethasone Disodium
Phosphate USP

5 mg/ml
1 mg/ml

36

Cadila Healthcare Ltd.


INDIA

Atenolol BP

100 mg

36

Cadila Healthcare Ltd.


INDIA

Glibenclamide BP

5 mg

48

Cadila Healthcare Ltd.


INDIA

24

Cadila Pharmaceuticals Ltd


INDIA

Catenol,Tablet

Dexona,Ophthalmic Solution

Catenol,Tablet

Betanase,Tablet

Cadila Pharmaceuticals Limited - INDIA


Roxibid,Tablet

Roxithromycin IH

Page 68 of 584

150 mg

Human Medicinal Products


S/No:

421.

Registration Number

TAN 09,109 J01D CAD

Product Name
Pack and Pack size

Ingredient(s) and Strength

423.

424.

425.

426.

427.

TAN 09,108 J01D CAD

TAN 00,245 P01X CAP

TAN 00,230 A02B CAP

TAN 05,847 C01K CAD

TAN 05,847 C01K CAD

TAN 05,850 M01B CAD

Manufacturer

Cefamor,Capsules
500 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Cefotaxime Sodium USP

250 mg/10ml

24

Cadila Pharmaceuticals Ltd


INDIA

Tinidazole BP

500 mg

48

Cadila Pharmaceuticals Ltd


INDIA

Ranitidine USP

150 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Amlodipine Besylate BP

10 mg

24

Cadila Healthcare Ltd.


INDIA

Amlodipine Besylate BP

10 mg

24

Cadila Healthcare Ltd.


INDIA

24

Cadila Pharmaceuticals Ltd


INDIA

Cephalexin Monohydrate
equivalent to Cephalexin
Anhydrous BP
422.

Shelf life
month

Oritaxime,Injection

Amtiba,Tablet

Aciloc,Tablet

Amdepin,Tablet

Amdepin,Tablet

Dexasone,Ear/Eye Drops
5.5 mg/ml
Neomycin Sulphate BP
Dexamethasone Sodium
1.04 mg/ml
Phosphate IH
Benzalkonium chloride USP 0.1 mg/ml

Page 69 of 584

Human Medicinal Products


S/No:

428.

429.

430.

431.

432.

433.

434.

Registration Number

TAN 05,850 M01B CAD

TAN 00,231 J01K CAP

TAN 00,232 J05A CAP

TAN 00,234 D078 CAP

TAN 00,235 S01A CAP

TAN 00,240 R05F CAP

TAN 00,241 J01D CAP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Dexasone,Ear/Eye Drops
5.5 mg/ml
Neomycin Sulphate BP
Dexamethasone Sodium
1.04 mg/ml
Phosphate IH
Benzalkonium chloride USP 0.1 mg/ml

24

Cadila Pharmaceuticals Ltd


INDIA

Perfloxacin IH

400 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Acyclovir BP

200 mg

48

Cadila Pharmaceuticals Ltd


INDIA

Iodochlorohydroxyquin BP
Dexamethasone Sodium
USP

3 %w/w
0.05 %w/w

36

Cadila Pharmaceuticals Ltd


INDIA

Acyclovir BP

5 %w/w

36

Cadila Pharmaceuticals Ltd


INDIA

Ammonium Chloride BP
Chlorpheniramine Maleate
USP
Guaiphenesin USP

100 mg/5ml
2 mg/5ml

48

Cadila Pharmaceuticals Ltd


INDIA

Cefotaxime Sodium USP

1000 mg/ml

24

Cadila Pharmaceuticals Ltd


INDIA

Peflobid,Tablet

Vivorax,Tablet

Dexaquine,Ointment

Vivorax skin,Cream

Cadiphen,Syrup

80 mg/5ml

Oritaxim,Injection

Page 70 of 584

Human Medicinal Products


S/No:

435.

436.

437.

438.

439.

440.

Registration Number

TAN 00,242 N02C CAP

TAN 00,244 D01B CAP

TAN 00,248 C01E CAP

TAN 00,298 R05A CAP

TAN 00,299 A04A CAP

TAN 00,303 C04A CAP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 06,022 J01D CAD

Manufacturer

Vasograin,Tablet
48

Cadila Pharmaceuticals Ltd


INDIA

150 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Enalapril Maleate USP

2.5 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Fluoxetine Hydrochloride
USP

20 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Domperidone BP

10 mg

48

Cadila Pharmaceuticals Ltd


INDIA

20 mg

36

Cadila Pharmaceuticals Ltd


INDIA

50 mg/5ml

24

Cadila Pharmaceuticals Ltd


INDIA

Caffeine Anhydrous BP
Paracetamol BP
Prochlorperazine Maleate
BP
Ergotamine Tartrate BP

100 mg
250 mg
2.5 mg

Fluconazole IH

1 mg

Fluzon,Tablet

Envas,Tablet

Fludac,Capsules

Domperon,Tablet

Calnif Retard,Tablet

Nifedipine USP

441.

Shelf life
month

Tambac 50,Suspension

Cefpodoxime Proxetil USP

Page 71 of 584

Human Medicinal Products


S/No:

442.

Registration Number

TAN 06,370 J02A CAD

Product Name
Pack and Pack size

Ingredient(s) and Strength

444.

445.

446.

TAN 07,276 A04A CAD

TAN 07,446 J04A CAD

TAN 00,2306 D04A CAD

TAN 00,4069 J01F CAD

200 mg/100ml

18

Cadila Pharmaceuticals Ltd


INDIA

Domperidone BP

1 mg/ml

24

Cadila Pharmaceuticals Ltd


INDIA

Ethambutol BP

400 mg

48

Cadila Pharmaceuticals Ltd


INDIA

Loratadine USP

10 mg

24

Cadila Pharmaceuticals Ltd


INDIA

200 mg/5ml

18

Cadila Pharmaceuticals Ltd


INDIA

Ciprofloxacin Hydrochloride 500 mg


USP

24

Cadila Pharmaceuticals Ltd


INDIA

Tinidazole BP

48

Cadila Pharmaceuticals Ltd


INDIA

Domperon,Suspension

Ethambutol,Tablet

Lorfast,Tablet

Zycin,Oral Suspension

Azithromycin Dihydrate eq
to Azithromycin USP

447.

448.

TAN 00,229 J01K CAP

TAN 00,245 P01X CAP

Manufacturer

Fluzon,Solution

Fluconazole USP

443.

Shelf life
month

Ciprodac,Tablet

Amtiba,Tablet

Page 72 of 584

500 mg

Human Medicinal Products


S/No:

449.

450.

451.

452.

453.

Registration Number

TAN 00,245 P01X CAP

TAN 09,276 A10B CAD

TAN 09,275 A10B CAD

TAN 09,274 A10B CAD

TAN 09,273 J01K CAD

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 09,272 J01K CAD

Tinidazole BP

500 mg

48

Cadila Pharmaceuticals Ltd


INDIA

Glimepiride USP

2 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Glimepiride USP

4 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Glimepiride USP

1 mg

24

Cadila Pharmaceuticals Ltd


INDIA

24

Cadila Pharmaceuticals Ltd


INDIA

24

Cadila Pharmaceuticals Ltd


INDIA

24

Cadila Pharmaceuticals Ltd


INDIA

Gluconorm,Tablet

Gluconorm,Tablet

Gluconorm,Tablet

Ceficad,Powder for Injection

Ceficad,Powder for Injection

Cefepime Hydrochloride
USP

455.

TAN 10, 006 A02A

Manufacturer

Amtiba,Tablet

Cefepime Hydrochloride Ph 1000 mg


Eur

454.

Shelf life
month

2000 mg

Locid Suspension,Suspension

Magnesium Hydroxide USP 100 mg/5ml


Aluminium Hydroxide USP 325 mg/5ml
125 mg/5ml
Polymethyl Siloxane USP

Page 73 of 584

Human Medicinal Products


S/No:

456.

457.

458.

459.

460.

461.

462.

Registration Number

TAN 00,230 A02B CAP

TAN 00,244 D01B CAP

TAN 00,244 D01B CAP

TAN 00,247 C01E CAP

TAN 00,247 C01E CAP

TAN 00,298 R05A CAP

TAN 00,298 R05A CAP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Aciloc,Tablet

Ranitidine USP

150 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Fluconazole IH

150 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Fluconazole IH

150 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Enalapril Maleate USP

10 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Enalapril Maleate USP

10 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Fluoxetine Hydrochloride
USP

20 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Fluoxetine Hydrochloride
USP

20 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Fluzon,Tablet

Fluzon,Tablet

Envas,Tablet

Envas,Tablet

Fludac,Capsules

Fludac,Capsules

Page 74 of 584

Human Medicinal Products


S/No:

463.

464.

465.

Registration Number

TAN 00,299 A04A CAP

TAN 00,299 A04A CAP

TAN 00,303 C04A CAP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 00,303 C04A CAP

Domperidone BP

10 mg

48

Cadila Pharmaceuticals Ltd


INDIA

Domperidone BP

10 mg

48

Cadila Pharmaceuticals Ltd


INDIA

20 mg

36

Cadila Pharmaceuticals Ltd


INDIA

20 mg

36

Cadila Pharmaceuticals Ltd


INDIA

50 mg/5ml

24

Cadila Pharmaceuticals Ltd


INDIA

Cefpodoxime Proxetil USP

50 mg/5ml

24

Cadila Pharmaceuticals Ltd


INDIA

Perfloxacin IH

400 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Domperon,Tablet

Calnif Retard,Tablet

Calnif Retard,Tablet

Nifedipine USP

467.

TAN 06,022 J01D CAD

Tambac 50,Suspension

Cefpodoxime Proxetil USP

468.

469.

TAN 06,022 J01D CAD

TAN 00,231 J01K CAP

Manufacturer

Domperon,Tablet

Nifedipine USP

466.

Shelf life
month

Tambac 50,Suspension

Peflobid,Tablet

Page 75 of 584

Human Medicinal Products


S/No:

470.

471.

472.

473.

474.

475.

476.

Registration Number

TAN 00,231 J01K CAP

TAN 00,232 J05A CAP

TAN 00,234 D078 CAP

TAN 00,235 S01A CAP

TAN 00,240 R05F CAP

TAN 00,240 R05F CAP

TAN 00,241 J01D CAP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Peflobid,Tablet

Perfloxacin IH

400 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Acyclovir BP

200 mg

48

Cadila Pharmaceuticals Ltd


INDIA

Iodochlorohydroxyquin BP
Dexamethasone Sodium
USP

3 %w/w
0.05 %w/w

36

Cadila Pharmaceuticals Ltd


INDIA

Acyclovir BP

5 %w/w

36

Cadila Pharmaceuticals Ltd


INDIA

Ammonium Chloride BP
Chlorpheniramine Maleate
USP
Guaiphenesin USP

100 mg/5ml
2 mg/5ml

48

Cadila Pharmaceuticals Ltd


INDIA

Ammonium Chloride BP
Chlorpheniramine Maleate
USP
Guaiphenesin USP

100 mg/5ml
2 mg/5ml

48

Cadila Pharmaceuticals Ltd


INDIA

Cefotaxime Sodium USP

1000 mg/ml

24

Cadila Pharmaceuticals Ltd


INDIA

Vivorax,Tablet

Dexaquine,Ointment

Vivorax skin,Cream

Cadiphen,Syrup

80 mg/5ml

Cadiphen,Syrup

80 mg/5ml

Oritaxim,Injection

Page 76 of 584

Human Medicinal Products


S/No:

477.

478.

479.

480.

481.

482.

Registration Number

TAN 00,241 J01D CAP

TAN 00,244 D01B CAP

TAN 00,244 D01B CAP

TAN 00,299 A04A CAP

TAN 00,299 A04A CAP

TAN 00,303 C04A CAP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 00,303 C04A CAP

Manufacturer

Oritaxim,Injection

Cefotaxime Sodium USP

1000 mg/ml

24

Cadila Pharmaceuticals Ltd


INDIA

Fluconazole IH

150 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Fluconazole IH

150 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Domperidone BP

10 mg

48

Cadila Pharmaceuticals Ltd


INDIA

Domperidone BP

10 mg

48

Cadila Pharmaceuticals Ltd


INDIA

20 mg

36

Cadila Pharmaceuticals Ltd


INDIA

20 mg

36

Cadila Pharmaceuticals Ltd


INDIA

Fluzon,Tablet

Fluzon,Tablet

Domperon,Tablet

Domperon,Tablet

Calnif Retard,Tablet

Nifedipine USP

483.

Shelf life
month

Calnif Retard,Tablet

Nifedipine USP

Page 77 of 584

Human Medicinal Products


S/No:

484.

485.

Registration Number

TAN 00,238 R03A CAP

TAN 00,240 R05F CAP

Registrant
486.

487.

488.

TAN 06,137 A02B CON

TAN 06,136 J01K CON

TAN 06,387 J01D CON

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 06,386 J01D CON

Manufacturer

Envas,Tablet

Enalapril Maleate USP

5 mg

24

Cadila Pharmaceuticals Ltd


INDIA

Ammonium Chloride BP
Chlorpheniramine Maleate
USP
Guaiphenesin USP

100 mg/5ml
2 mg/5ml

48

Cadila Pharmaceuticals Ltd


INDIA

Cadiphen,Syrup

80 mg/5ml

CCL Pharmaceutical Ltd - PAKISTAN


Proloc,Capsules

Omeprazole BP

20 mg

36

CCL Pharmaceutical Ltd


PAKISTAN

Ofloxacin USP

200 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

250 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

1000 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

Eracin,Tablet

Ceftorince,Injectable Solution

Cefotaxime Sodium USP

489.

Shelf life
month

Ceftorince,Injectable Solution

Cefotaxime Sodium USP

Page 78 of 584

Human Medicinal Products


S/No:

490.

491.

492.

493.

494.

495.

496.

Registration Number

TAN 10, 075 A10B CON

TAN 10, 089 A10B CON

TAN 10,081 B03A CON

TAN 10, 080 J01D CON

TAN 10, 078 J01F CON

TAN 10, 076 J01D CON

TAN 10, 075 A10B CON

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Orinase,Tablet

Glimepiride USP

1 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

Glimepiride USP

2 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

Ferrous Sulphate BP
Folic Acid BP

200 mg
5 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

Cefuroxime Axetil BP

125 mg/5ml

18

CCL Pharmaceutical Ltd


PAKISTAN

Cefuroxime Axetil BP

750 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

Cefuroxime Axetil IH

250 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

Glimepiride USP

1 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

Orinase,Tablet

Ferrocap TR,Capsules

Kefrox,Suspension

Kefrox,Powder for Injection

Kefrox,Tablet

Orinase,Tablet

Page 79 of 584

Human Medicinal Products


S/No:

497.

Registration Number

TAN 10, 089 A10B CON

Product Name
Pack and Pack size

Ingredient(s) and Strength

498.

499.

500.

501.

502.

TAN 06,371 J03C CEN

TAN 00,4265 J02A CEN

TAN 00,4349 D01A CEN

TAN 00,4422 D01A CEN

TAN 00,4421 D01A CEN

Manufacturer

Orinase,Tablet

Glimepiride USP

Registrant

Shelf life
month

2 mg

24

CCL Pharmaceutical Ltd


PAKISTAN

Centaur Pharmaceuticals Pvt. Ltd. - INDIA


Argisept,Cream

Chlorhexidine Gluconate BP 2 %w/w


1 %w/w
Silver Sulphadiazine USP

24

Clotrimazole BP

1 %w/w

36

Miconazole BP

20 mg/g

36

Benzoyl Peroxide BP

2.5 %w/w

24

Benzoyl Peroxide BP

5 %w/w

24

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Translipo C,Cream
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Micona,Gel
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Benzox,Gel
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Benzox,Gel

Page 80 of 584

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Human Medicinal Products


S/No:

503.

504.

505.

506.

507.

Registration Number

TAN 05,148 M02A CEN

TAN 05,150 J01K CEN

TAN 05,149 J01K CEN

TAN 06,023 S01B CEN

TAN 06,132 J05A CEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Inflazone,Ointment

Diclofenac Sodium BP
Eucalyptus Oil BP
Menthol BP
Mephenesin BP
Camphor oil USP
Methyl Salicylate

12.18 mg/g
52.5 mg/g
105 mg/g
52.5 mg/g
52.5 mg/g
105 mg/g

Methyl Salicylate USP


Capsaicin USP

0.788 mg/g

36

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Oculo-D,Ointment
30

Polymyxin B Sulphate USP


Dexamethasone Sodium
Sulphate BP
Chloramphenicol USP

10000 unit/g
1 mg/g

Chloramphenicol USP
Polymyxin B Sulphate USP

10 mg/ml
1000 units/ml

30

Betamethasone
Dipropionate USP

0.06825 %w/w

36

Acyclovir BP

3 %w/w

24

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

10 mg/g

Ocupol,Ointment
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Tasone,Cream
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Eyevir,Ointment

Page 81 of 584

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Human Medicinal Products


S/No:

508.

509.

510.

511.

512.

513.

514.

Registration Number

TAN 06,258 J01G CEN

TAN 07,145 D07X CEN

TAN 07,146 D07C CEN

TAN 07,147 D01A CEN

TAN 07,148 D07B CEN

TAN 07,144 D07C CEN

TAN 00,4265 J02A CEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Centamicin,Solution

Gentamycin Sulphate BP

0.3 %w/v

36

Gentamycin Sulphate BP
Betamethasone Valerate BP
Tolnaftate BP
Iodochlorohydroxyquin BP

0.1 %w/w
0.5 %w/w
1 %w/w
1 %w/w

24

0.5 %w/w
Neomycin Sulphate BP
Betamethasone Valerate BP 0.5 %w/w

24

Hydrous Benzoyl Peroxide


BP
Precipated Sulphur USP

10 %w/w

36

Betamethasone
Dipropionate BP
Salicylic Acid BP

3 %w/w

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Dermaquat,Cream
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Netasole,Ointment
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Benzox,Cream

5 %w/w

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Entezma,Ointment
36

0.05 %w/v

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Netasole,Cream
0.5 %w/w
Neomycin Sulphate BP
Betamethasone Valerate BP 0.5 %w/w

24

Clotrimazole BP

36

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Translipo C,Cream

Page 82 of 584

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Human Medicinal Products


S/No:

515.

516.

517.

518.

519.

520.

521.

Registration Number

TAN 00,4265 J02A CEN

TAN 00,4349 D01A CEN

TAN 00,4349 D01A CEN

TAN 00,4422 D01A CEN

TAN 00,4422 D01A CEN

TAN 00,4421 D01A CEN

TAN 00,4421 D01A CEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Translipo C,Cream

Clotrimazole BP

36

Miconazole BP

20

36

Miconazole BP

20

36

Benzoyl Peroxide BP

2.5

24

Benzoyl Peroxide BP

2.5

24

Benzoyl Peroxide BP

24

Benzoyl Peroxide BP

24

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Micona,Gel
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Micona,Gel
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Benzox,Gel
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Benzox,Gel
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Benzox,Gel
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Benzox,Gel

Page 83 of 584

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Human Medicinal Products


S/No:

522.

523.

524.

525.

Registration Number

TAN 05,148 M02A CEN

TAN 05,148 M02A CEN

TAN 05,150 J01K CEN

TAN 05,150 J01K CEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Inflazone,Ointment

Diclofenac Sodium BP
Eucalyptus Oil BP
Menthol BP
Mephenesin BP
Camphor oil USP
Methyl Salicylate

12.18
52.5
105
52.5
52.5
105

Methyl Salicylate USP


Capsaicin USP

0.788

Diclofenac Sodium BP
Eucalyptus Oil BP
Menthol BP
Mephenesin BP
Camphor oil USP
Methyl Salicylate

12.18
52.5
105
52.5
52.5
105

Methyl Salicylate USP


Capsaicin USP

0.788

36

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Inflazone,Ointment
36

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Oculo-D,Ointment

Polymyxin B Sulphate USP


Dexamethasone Sodium
Sulphate BP
Chloramphenicol USP

10000
1

Polymyxin B Sulphate USP


Dexamethasone Sodium
Sulphate BP
Chloramphenicol USP

10000
1

30

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

10

Oculo-D,Ointment

Page 84 of 584

10

30

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Human Medicinal Products


S/No:

526.

527.

Registration Number

TAN 05,149 J01K CEN

TAN 05,149 J01K CEN

Registrant
528.

529.

530.

531.

TAN 09,113 M01A CHE

TAN 06,373 J01K CHE

TAN 06,372 R01A CHE

TAN 06,374 R01A CHE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Ocupol,Ointment

Chloramphenicol USP
Polymyxin B Sulphate USP

10
1000

30

Chloramphenicol USP
Polymyxin B Sulphate USP

10
1000

30

Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Ocupol,Ointment
Centaur Pharmaceuticals
Pvt Ltd-Plant II
INDIA

Chemical Industries Development - EGYPT


Aspo Cid,Tablet

Acetylsalicylic Acid BP

75 mg

36

Norfloxacin USP

0.3 %

24

Xylometazoline
Hydrochloride BP

0.05 %

36

Xylometazoline
Hydrochloride IH

0.01 g

36

Chemical Industries
Development
EGYPT

Opto Q3,Solution
Chemical Industries
Development
EGYPT

Rhinex,Nasal Drops
Chemical Industries
Development
EGYPT

Rhinex,Nasal Drops

Page 85 of 584

Chemical Industries
Development
EGYPT

Human Medicinal Products


S/No:

532.

Registration Number

TAN 09,009 A02A CHE

Product Name
Pack and Pack size

Ingredient(s) and Strength

533.

TAN 05,467 J01K CHE

TAN 05,468 J01K CHE

535.

TAN 08,133 J01H E.D

Gentamycin,Injectable
Solution

200 mg/100ml

24

80 mg/2ml

36

536.

TAN 00,4533 J05A CIP

Chemical Industries
Development
EGYPT

Sichuan Kelun
Pharmaceutical Factory
CHINA

Leshan Sanjiu-LongMarch
Pharmaceutical Co. Ltd
CHINA

Cimex AG Pharmazeutika - SWITZERLAND


Amoxi-Denk,Tablet

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

Registrant

36

Ciprofloxacin,Solution

Gentamycin Sulphate IH

Registrant

50 mg/5ml
0.025 g/5ml
0.0015 ml/5ml
0.0015 ml/5ml
0.0015 ml/5ml
0.05 ml/5ml

Chengdu Kind International Trading Co. Ltd - CHINA


Ciprofloxacin Lactate IH

534.

Manufacturer

CID Water Syrup,Syrup

Sodium Bicarbonate IH
Potassium Citrate IH
Oil of dill IH
Oil of caraway IH
Oil of fennel IH
Tincture of ginger IH

Registrant

Shelf life
month

36

Denk Pharma GmbH & Co.


KG
GERMANY

Cipla Ltd - INDIA


Zidovir,Solution

Zidovudine USP

Page 86 of 584

50 mg/5ml

24

Cipla Ltd.
INDIA

Human Medicinal Products


S/No:

537.

Registration Number

TAN 00,648 R03A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

539.

540.

541.

542.

543.

TAN 00,1010 J01D CIP

TAN 00,995 C01K CIP

TAN 00,1569 V03A CIP

TAN 09,117 B01A CIP

TAN 00,4533 J05A CIP

TAN 00,4535 J05A CIP

Manufacturer

Asthalin,Aerosol
100 mcg/dose

36

Cipla Ltd.
INDIA

Cefadroxil IP

250 mg/5ml

18

OSCAR ERNEST MGIMBE


TANZANIA

Doxazocin Mesylate IH

2 mg

36

Cipla Ltd.
INDIA

Cetrizine Hydrochloride IP
Pseudoephedrine
Hydrochloride IP

120 mg
5 mg

48

Cipla Ltd.
INDIA

Warfarin Sodium USP

1 mg

36

Cipla Ltd.
INDIA

Zidovudine USP

50 mg/5ml

24

Cipla Ltd.
INDIA

Nevirapine USP

200 mg

24

Cipla Ltd.
INDIA

Salbutamol IH

538.

Shelf life
month

Cefadur,Suspension

Doxacard,Tablet

Alerid D ER,Tablet

Warf-1,Tablet

Zidovir,Solution

Nevimune,Tablet

Page 87 of 584

Human Medicinal Products


S/No:

544.

Registration Number

TAN 00,4592 J05A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

546.

547.

548.

549.

550.

TAN 09,115 C01A CIP

TAN 09,121 J05A CIP

TAN 09,119 G02A CIP

TAN 09,118 J05A CIP

TAN 09,116 J05A CIP

TAN 09,120 V02C CIP

Manufacturer

Nevimune,Suspension

Nevirapine hemihydrate
USP
Nevirapine IH
545.

Shelf life
month

51.70 mg

24

Cipla Ltd.
INDIA

50 mg/5ml

Trivedon MR,Tablet

Trimetazidine
Dihydrochloride IH

35 mg

36

Cipla Ltd.
INDIA

Nelfinavir IH

250 mg

36

Cipla Ltd.
INDIA

Misoprostol IH

100 mcg

18

Cipla Ltd.
INDIA

Stavudine USP

20 mg

24

Cipla Ltd.
INDIA

Stavudine USP

15 mg

36

Cipla Ltd.
INDIA

25 mg

36

Cipla Ltd.
INDIA

Nelvir,Tablet

Misoprost,Tablet

Stavir,Capsules

Stavir,Capsules

Imusporin,Capsules

Cyclosporine USP

Page 88 of 584

Human Medicinal Products


S/No:

551.

552.

553.

554.

555.

556.

557.

Registration Number

TAN 09,123 L01D CIP

TAN 00,2116 J05A CIP

TAN 00,4350 B04A CIP

TAN 00,4352 M05A CIP

TAN 05,096 L01B CIP

TAN 05,094 J05A CIP

TAN 05,093 L01C CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Cellmune,Tablet

Mycophenolate Mefetil IH

500 mg

24

Cipla Ltd.
INDIA

Zidovudine IH

100 mg

18

Cipla Ltd.
INDIA

Atorvastatin Calcium
10 mg
equivalent to Atorvastatin IP

18

Cipla Ltd.
INDIA

Raloxifene Hydrochloride
Eur/USP

60 mg

24

Cipla Ltd.
INDIA

Methotrexate USP

25 mg/ml

24

Cipla Ltd.
INDIA

Efavirenz IH

600 mg

24

Cipla Ltd.
INDIA

10 mg/ml

24

Cipla Ltd.
INDIA

Zidovir,Capsules

Atorlip,Tablet

Ralista,Tablet

Methocip,Injectable Solution

Efavir,Tablet

Oncodox,Injectable Solution

Doxorubicin Hydrochloride
USP

Page 89 of 584

Human Medicinal Products


S/No:

558.

559.

560.

561.

562.

563.

564.

Registration Number

TAN 05,095 L01C CIP

TAN 05,474 J05A CIP

TAN 05,477 R03A CIP

TAN 05,476 R03A CIP

TAN 05,475 R03A CIP

TAN 05,472 A10B CIP

TAN 05,471 A10B CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Oncodox,Injectable Solution

Doxorubicin Hydrochloride
USP

50 mg/ml

24

Cipla Ltd.
INDIA

Lamivudine IH

150 mg

24

Cipla Ltd.
INDIA

Bambuterol Hydrocloride IH 10 mg

36

Cipla Ltd.
INDIA

Fluticasone Propionate BP
Salmeterol Xinafoate eq to
Salmeterol IH

250 mcg
50 mcg

24

Cipla Ltd.
INDIA

Fluticasone Propionate BP 125 mcg


Salmeterol Xinafoate
25 mcg
equivalent to Salmeterol IH

24

Cipla Ltd.
INDIA

Pioglitazone Hydrochloride
BP

15 mg

24

Cipla Ltd.
INDIA

Pioglitazone Hydrochloride
BP

30 mg

24

Cipla Ltd.
INDIA

Lamivir,Tablet

Bambudil,Tablet

Seroflo 250
Rotacaps,Capsules

Seroflo 125,Inhaler

P-Glitz 15,Tablet

P-Glitz 30,Tablet

Page 90 of 584

Human Medicinal Products


S/No:

565.

Registration Number

TAN 05,470 L01C CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

567.

568.

569.

570.

571.

TAN 00,1010 J01D CIP

TAN 00,995 C01K CIP

TAN 00,2528 V03A CIP

TAN 10,054 J01C

TAN 05,603 J05A CIP

TAN 05,604 J05A CIP

Manufacturer

Cytocristin,Injection
1 mg/ml

18

Cipla Ltd.
INDIA

Cefadroxil Anhydrous
equivalent to Cefadroxil
USP
Cefadroxil IP

250 mg/5ml

18

OSCAR ERNEST MGIMBE


TANZANIA

Doxazocin Mesylate IH

2 mg

36

Cipla Ltd.
INDIA

Sildenafil Citrate IH

100 mg

36

Cipla Ltd.
INDIA

Tazobactum Sodium IH
Piperacillin Sodium IH

250 mg
2g

24

Cipla Ltd.
INDIA

Lamivudine IH

50 mg/ml

24

Cipla Ltd.
INDIA

Lamivudine IH
Zidovudine USP

150 mg
300 mg

24

Cipla Ltd.
INDIA

Vincristine Sulphate USP

566.

Shelf life
month

Cefadur,Suspension

250 mg/5ml

Doxacard,Tablet

Erecto,Tablet

Tazact,Powder for Injection

Lamivir,Solution

Duovir,Tablet

Page 91 of 584

Human Medicinal Products


S/No:

572.

573.

574.

575.

576.

577.

578.

Registration Number

TAN 05,605 J05A CIP

TAN 05,606 J05A CIP

TAN 05,608 J05A CIP

TAN 05,609 J05A CIP

TAN 05,620 J05A CIP

TAN 05,611 J05A CIP

TAN 05,602 J05A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Stavir,Capsules

Stavudine IH

30 mg

24

Cipla Ltd.
INDIA

Stavudine IH

40 mg

24

Cipla Ltd.
INDIA

Lamivudine IH
Nevirapine IH
Stavudine IH

150 mg
200 mg
40 mg

30

Cipla Ltd.
INDIA

Efavirenz IH

200 mg

24

Cipla Ltd.
INDIA

Zidovudine USP

100 mg

24

Cipla Ltd.
INDIA

Zidovudine USP

300 mg

36

Cipla Ltd.
INDIA

Indinavir Sulphate IH

400 mg

24

Cipla Ltd.
INDIA

Stavir,Capsules

Triomune 40,Tablet

Efavir,Capsules

Zidovir,Capsules

Zidovir,Tablet

Indivan,Capsules

Page 92 of 584

Human Medicinal Products


S/No:

579.

580.

581.

582.

583.

584.

585.

Registration Number

TAN 05,613 B04A CIP

TAN 05,614 B04A CIP

TAN 05,598 J01K CIP

TAN 05,616 A04A CIP

TAN 05,610 R06A CIP

TAN 05,618 R03A CIP

TAN 05,619 R03A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Atorlip,Tablet

Atorvastatin Calcium
equivalent to Atorvastatin
IH

10 mg

18

Cipla Ltd.
INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

18

Cipla Ltd.
INDIA

Ofloxacin USP

400 mg

36

Cipla Ltd.
INDIA

Ondansteron Hydrochloride 8 mg
USP

36

Cipla Ltd.
INDIA

Cetrizine Hydrochloride BP 10 mg

36

Cipla Ltd.
INDIA

Budesonide BP

100 mcg

24

Cipla Ltd.
INDIA

Budesonide BP

200 mcg

24

Cipla Ltd.
INDIA

Atorlip,Tablet

Oflox,Capsules

Emeset,Tablet

Alerid,Tablet

Budecort,Capsules

Budecort,Capsules

Page 93 of 584

Human Medicinal Products


S/No:

586.

587.

588.

589.

590.

591.

592.

Registration Number

TAN 05,612 R03A CIP

TAN 05,622 R03A CIP

TAN 05,596 R03A CIP

TAN 05,615 R03A CIP

TAN 05,592 C01K CIP

TAN 05,587 R03A CIP

TAN 05,588 R06A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Budecort,Capsules

Budesonide BP

400 mcg

24

Cipla Ltd.
INDIA

Budesonide BP

1 mg/2ml

24

Cipla Ltd.
INDIA

Budesonide BP

0.5 mg/2ml

24

Cipla Ltd.
INDIA

Salbutamol Sulphate
2.5 mg
equivalent to Salbutamol BP

36

Cipla Ltd.
INDIA

Amlodipine Besylate IH

36

Cipla Ltd.
INDIA

Beclomethasone
50 mcg
Dipropionate BP
Salbutamol Sulphate
100 mcg
equivalent to Salbutamol BP

36

Cipla Ltd.
INDIA

Cetrizine Hydrochloride BP 5 mg/5ml

30

Cipla Ltd.
INDIA

Budecort,Respules

Budecort,Solution

Asthalin,Solution

Amlopres,Tablet
10 mg

Aerocort,Aerosol Inhaler

Alerid,Syrup

Page 94 of 584

Human Medicinal Products


S/No:

593.

Registration Number

TAN 05,589 R01A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

595.

596.

597.

598.

599.

TAN 05,590 R03A CIP

TAN 05,591 R03A CIP

TAN 05,586 R03A CIP

TAN 05,593 R03A CIP

TAN 05,594 A04A CIP

TAN 05,595 A02B CIP

Manufacturer

Cromal,Inhaler
36

Cipla Ltd.
INDIA

Salbutamol Sulphate
200 mcg
equivalent to Salbutamol BP

36

Cipla Ltd.
INDIA

Salbutamol Sulphate
100 mcg/dose
equivalent to Salbutamol BP

36

Cipla Ltd.
INDIA

Cromolyn Sodium USP

594.

Shelf life
month

5 mg/dose

Asthalin,Capsules

Asthalin,Inhaler

Ipravent Respules,Solution

Ipratropim Bromide BP

500 mcg

36

Cipla Ltd.
INDIA

Ipratropim Bromide BP

20 mcg/dose

36

Cipla Ltd.
INDIA

Ondansetron Hydrochloride 4 mg
eq to Ondansetron USP

36

Cipla Ltd.
INDIA

Omeprazole BP

36

Cipla Ltd.
INDIA

Ipravent,Inhaler

Emeset,Tablet

Lomac,Capsules

Page 95 of 584

20 mg

Human Medicinal Products


S/No:

600.

601.

602.

603.

604.

605.

606.

Registration Number

TAN 05,601 R06A CIP

TAN 05,473 C01K CIP

TAN 05,597 V07A CIP

TAN 05,585 V07A CIP

TAN 05,599 A02C CIP

TAN 05,599 A02C CIP

TAN 05,600 R03A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Alerid,Tablet

Cetrizine Hydrochloride BP 5 mg

36

Cipla Ltd.
INDIA

Amlodipine Besylate IH

5 mg

36

Cipla Ltd.
INDIA

Simvastatin USP

20 mg

36

Cipla Ltd.
INDIA

Simvastatin USP

10 mg

36

Cipla Ltd.
INDIA

Albendazole USP

200 mg/5ml

36

Cipla Ltd.
INDIA

Albendazole USP

200 mg/5ml

36

Cipla Ltd.
INDIA

0.2 %w/v

24

Cipla Ltd.
INDIA

Amlopres,Tablet

Simcard,Tablet

Simcard,Tablet

Bendex,Suspension

Bendex,Suspension

Budenase AQ,Nasal Spray

Budesonide BP

Page 96 of 584

Human Medicinal Products


S/No:

607.

608.

609.

610.

611.

Registration Number

TAN 05,617 J01K CIP

TAN 05,627 J05A CIP

TAN 05,625 L01C CIP

TAN 05,624 L01C CIP

TAN 05,621 L01A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,623 L01A CIP

Ofloxacin USP

200 mg

36

Cipla Ltd.
INDIA

Nevirapine IH
Zidovudine USP
Lamivudine IH

200 mg
300 mg
150 mg

24

Cipla Ltd.
INDIA

Tamoxifen (as Citrate) USP


Tamoxifen Citrate BP

30.40 mg
20 mg

36

Cipla Ltd.
INDIA

Etoposide USP

100 mg/5ml

36

Cipla Ltd.
INDIA

1 mg/ml

36

Cipla Ltd.
INDIA

10 mg/20ml

36

Cipla Ltd.
INDIA

10 mg/10ml

24

Cipla Ltd.
INDIA

Duovir N,Tablet

Cytotam-20,Tablet

Etosid,Injection

Cytoplatin,Injection

Cytoplatin,Injection

Cisplatin USP

613.

TAN 05,752 V07A CIP

Manufacturer

Oflox,Tablet

Cisplatin USP

612.

Shelf life
month

Cytoblastin,Injection

Vinblastine Sulphate USP

Page 97 of 584

Human Medicinal Products


S/No:

614.

Registration Number

TAN 05,751 L01X CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Docetax-20,Injectable
Solution

616.

617.

618.

619.

620.

TAN 06,035 P01B CIP

TAN 06,034 J05A CIP

TAN 06,033 J05A CIP

TAN 06,032 J05A CIP

TAN 06,036 J05A CIP

TAN 06,029 J05A CIP

Manufacturer

24

Cipla Ltd.
INDIA

20 mg
Artesunate IH
Amodiaquine Hydrochloride 200 mg
USP

24

Cipla Ltd.
INDIA

Didanosine IH

25 mg

24

Cipla Ltd.
INDIA

Didanosine IH

50 mg

24

Cipla Ltd.
INDIA

Didanosine Ph Eur

150 mg

24

Cipla Ltd.
INDIA

Lamivudine IH
Stavudine IH

150 mg
30 mg

36

Cipla Ltd.
INDIA

150 mg
40 mg

36

Cipla Ltd.
INDIA

Docetaxel Trihydrate
equivalent to Docetaxel IH

615.

Shelf life
month

20 mg/5ml

Falcimon,Tablet

Divir 25,Tablet

Divir 50,Tablet

Divir 150,Tablet

Lamivir-S,Tablet

Lamivir-S 40,Tablet

Lamivudine IH
Stavudine IH

Page 98 of 584

Human Medicinal Products


S/No:

621.

Registration Number

TAN 06,028 J05A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

623.

624.

625.

626.

TAN 06,037 J05A CIP

TAN 06,027 J05A CIP

TAN 06,031 R03A CIP

TAN 06,026 R03A CIP

TAN 06,135 R03A CIP

133.3 mg
33.3 mg

18

Cipla Ltd.
INDIA

Ritonavir IH

100 mg

18

Cipla Ltd.
INDIA

Acyclovir BP

5 %w/w

36

Cipla Ltd.
INDIA

0.021 %w/v
Ipratropim Bromide BP
Salbutamol Sulphate
0.12 %w/v
equivalent to Salbutamol BP

36

Cipla Ltd.
INDIA

Beclomethasone
100 mcg
Dipropionate BP
Salbutamol Sulphate
200 mcg
equivalent to Salbutamol BP

36

Cipla Ltd.
INDIA

200 mcg/actuation

36

Cipla Ltd.
INDIA

100 mcg/dose

36

Cipla Ltd.
INDIA

Ritomune-100,Capsules

Acivir,Cream

Duolin,Solution

Aerocort,Capsules

Budecort-200,Inhaler

Budesonide BP

627.

TAN 06,134 R03A CIP

Manufacturer

Lopimune,Capsules

Lopinavir IH
Ritonavir IH

622.

Shelf life
month

Budecort-100,Inhaler

Budesonide BP

Page 99 of 584

Human Medicinal Products


S/No:

628.

629.

630.

631.

632.

Registration Number

TAN 06,263 L01B CIP

TAN 06,267 N02B CIP

TAN 06,268 G02A CIP

TAN 07,277 J03C CIP

TAN 06,262 R03A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 06,261 R03A CIP

Methotrexate USP

2.5 mg

36

Cipla Ltd.
INDIA

Celecoxib IH

100 mg

24

Cipla Ltd.
INDIA

Misoprostol IH

200 mcg

18

Cipla Ltd.
INDIA

Adapalene IH

0.1 %w/w

24

Cipla Ltd.
INDIA

100 mcg/spray
6 mcg/spray

24

Cipla Ltd.
INDIA

40 mcg

36

Cipla Ltd.
INDIA

200 mcg/spray
6 mcg/spray

24

Cipla Ltd.
INDIA

Cobix-100,Capsules

Misoprost-200,Tablet

Adaclene,Gel

Foracort 100,Inhaler

Ipravent,Powder for
inhalation

Ipratropim Bromide BP

634.

TAN 06,260 R03A CIP

Manufacturer

Imutrex-2.5,Tablet

Budesonide BP
Formoterol Fumarate
Dihydrate Ph Eur
633.

Shelf life
month

Foracort 200,Inhaler

Budesonide BP
Formoterol Fumarate
Dihydrate BP

Page 100 of 584

Human Medicinal Products


S/No:

635.

636.

637.

638.

639.

640.

Registration Number

TAN 06,266 R03A CIP

TAN 06,269 R03A CIP

TAN 06,259 R03A CIP

TAN 06,378 N02B CIP

TAN 06,375 J05A CIP

TAN 06,377 R03A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 06,381 R03A CIP

Manufacturer

Seroflo-250,Inhaler

Fluticasone Propionate BP 250 mcg/spray


Salmeterol Xinafoate
25 mcg/spray
equivalent to Salmeterol IH

24

Cipla Ltd.
INDIA

Fluticasone Propionate BP 50 mcg/spray


Salmeterol Xinafoate
25 mcg/spray
equivalent to Salmeterol IH

24

Cipla Ltd.
INDIA

40 mcg
Ipratropim Bromide BP
Salbutamol Sulphate
200 mcg
equivalent to Salbutamol BP

24

Cipla Ltd.
INDIA

Paracetamol BP

500 mg

36

Cipla Ltd.
INDIA

Abacavir Sulphate
equivalent to Abacavir IH

300 mg

18

Cipla Ltd.
INDIA

24

Cipla Ltd.
INDIA

12

Cipla Ltd.
INDIA

Seroflo-50,Inhaler

Duolin,Inhaler

Parafizz,Tablet

Abamune,Tablet

Seroflo 100,Multi-haler

Fluticasone Propionate BP 100 mcg/dose


Salmeterol Xinafoate
50 mcg/dose
equivalent to Salmeterol IH
641.

Shelf life
month

Foracort 100,Rotacaps

Budesonide BP
Formoterol Fumarate
Dihydrate Ph Eur

Page 101 of 584

100 mcg
6 mcg

Human Medicinal Products


S/No:

642.

Registration Number

TAN 06,376 R03A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

644.

TAN 06,380 L01B CIP

TAN 06,379 L01B CIP

100 mcg
6 mcg

12

Cipla Ltd.
INDIA

Gemcitabine Hydrochloride 1000 mg


IH

24

Cipla Ltd.
INDIA

24

Cipla Ltd.
INDIA

Oncogem 1000,Injectable
Solution

Oncogem 200,Injectable
Solution

Gemcitabine Hydrochloride 200 mg


IH

645.

TAN 07,016 D01A CIP

Nystatin,Suspension

Nystatin BP

646.

647.

648.

TAN 07,013 R03A CIP

TAN 07,012 V03A CIP

TAN 07,010 A06A CIP

Manufacturer

Foracort 200,Capsules

Budesonide BP
Formoterol Fumarate
Dihydrate Ph Eur
643.

Shelf life
month

100000 IU

24

Cipla Ltd at Mediorals


Laboratories PVT Ltd.
INDIA

Seroflo 100,Rotacaps

Fluticasone Propionate BP 100 mcg


Salmeterol Xinafoate
50 mcg
equivalent to Salmeterol IH

24

Cipla Ltd.
INDIA

Risedronate Sodium IH

35 mg

24

Cipla Ltd.
INDIA

Carboxymethyl cellulose
USP

1%

18

Cipla Ltd.
INDIA

Risofos,Tablet

Flogel,Solution

Page 102 of 584

Human Medicinal Products


S/No:

649.

Registration Number

TAN 07,009 D07A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

651.

652.

653.

654.

655.

TAN 07,017 R03A CIP

TAN 07,011 R03A CIP

TAN 07,154 C04A CIP

TAN 07,149 R03A CIP

TAN 07,153 B01A CIP

TAN 07,150 B04A CIP

Manufacturer

Metaspray,Spray
50 mcg

36

Cipla Ltd.
INDIA

Salbutamol Sulphate
0.6 mg
equivalent to Salbutamol IH

24

Cipla Ltd.
INDIA

Salbutamol Sulphate
1.25 mg
equivalent to Salbutamol IH

24

Cipla Ltd.
INDIA

Tadalafil IH

10 mg

24

Cipla Ltd.
INDIA

Tiotropium Bromide
Monohydrate equivalent to
Tiotropium IH

9 mcg/spray

24

Cipla Ltd.
INDIA

Acetylsalicylic Acid BP
Clopidogrel Bisulfate USP

75 mg
75 mg

24

OSCAR ERNEST MGIMBE


TANZANIA

Atorvastatin Calcium IH

40 mg/0.5ml

24

Cipla Ltd.
INDIA

Mometasone Furoate USP

650.

Shelf life
month

Levolin,Solution

Levolin,Solution

Tadacip-10,Tablet

Tiova,Aerosol

Clopivas AP 75,Tablet

Atorlip,Tablet

Page 103 of 584

Human Medicinal Products


S/No:

656.

Registration Number

TAN 07,155 J05A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

658.

659.

660.

661.

662.

TAN 07,151 L01A CIP

TAN 07,156 C06A CIP

TAN 00,1572 P01A CIP

TAN 07,278 R03A CIP

TAN 07,279 R03A CIP

TAN 07,281 C06A CIP

Manufacturer

Tenvir,Tablet
300 mg

24

Cipla Ltd.
INDIA

Dacarbazine USP

200 mg

24

Cipla Ltd.
INDIA

Carvedilol BP

6.25 mg

36

Cipla Ltd.
INDIA

Secnidazole
Secnidazole IH

100 mg

36

Cipla Ltd.
INDIA

Tiotropium Bromide
Monohydrate IH
Formoterol Fumarate IH

9 mcg

24

Cipla Ltd.
INDIA

Tiotropium Bromide
Monohydrate IH

18 mcg

18

Cipla Ltd.
INDIA

Carvedilol Ph Eur

3.125 mg

36

Cipla Ltd
INDIA

Tenofovir Disoproxil
Fumarate IH

657.

Shelf life
month

Decarb,Injectable Solution

Carloc,Tablet

Entosec,Tablet

Duova,Aerosol

6 mcg

Tiova,Rotacaps

Carloc,Tablet

Page 104 of 584

Human Medicinal Products


S/No:

663.

664.

665.

666.

667.

Registration Number

TAN 07,284 J03B CIP

TAN 07,286 C03C CIP

TAN 07,287 C03C CIP

TAN 07,288 R03A CIP

TAN 07,290 J05A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 07,292 L01A CIP

Manufacturer

Ciplin,Suspension

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

36

Cipla Ltd.
INDIA

Torsemide IH
Bromhexine Hydrochloride
BP
Guaiphenesin BP
Menthol BP
Terbutaline Sulphate BP

5 mg
8 mg

24

Cipla Ltd.
INDIA

Torsemide IH

10 mg

24

Cipla Ltd.
INDIA

Theophyline BP

400 mg

24

OSCAR ERNEST MGIMBE


TANZANIA

30 mg
50 mg
6 mg

24

Cipla Ltd.
INDIA

10 mg/ml

24

Cipla Ltd.
INDIA

Dytor,Tablet

100 mg
5 mg
2.5 mg

Dytor,Tablet

Theoday,Tablet

Triomune baby,Dispersible
Tablets

Lamivudine USP
Nevirapine USP
Stavudine USP

668.

Shelf life
month

Cytocarb,Injectable Solution

Carboplatin USP

Page 105 of 584

Human Medicinal Products


S/No:

669.

670.

671.

672.

Registration Number

TAN 07,294 C01K CIP

TAN 07,291 C01E CIP

TAN 07,293 L02B CIP

TAN 07,452 R03A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

674.

675.

TAN 07,453 R03A CIP

TAN 07,450 R03A CIP

TAN 07,458 R03A CIP

Manufacturer

Ramipres,Capsules

Ramipril BP

5 mg

24

Cipla Ltd.
INDIA

Lisinopril USP

10 mg

36

Cipla Ltd.
INDIA

Finasteride IH

5 mg

24

Cipla Ltd.
INDIA

24

Cipla Ltd.
INDIA

Fluticasone Propionate BP 500 mcg/dose


Salmeterol Xinafoate
50 mcg/dose
equivalent to Salmeterol IH

24

Cipla Ltd.
INDIA

Levosalbutamol IH

50 mcg

24

Cipla Ltd.
INDIA

Levosalbutamol IH

100 mcg

24

Cipla Ltd.
INDIA

Cipril,Tablet

Fincar,Tablet

Seroflo-250,Multi-haler

Fluticasone Propionate BP 250 mcg/dose


Salmeterol Xinafoate
50 mcg/dose
equivalent to Salmeterol IH
673.

Shelf life
month

Seroflo 500,Multi-haler

Levolin,Aerosol

Levolin,Aerosol

Page 106 of 584

Human Medicinal Products


S/No:

676.

677.

678.

679.

680.

681.

682.

Registration Number

TAN 07,457 R03A CIP

TAN 07,456 J05A CIP

TAN 07,451 D01B CIP

TAN 07,459 D07A CIP

TAN 07,449 G04B CIP

TAN 07,448 G04B CIP

TAN 07,447 J01F CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Duova,Aerosol
Cipla Ltd.
INDIA

Formoterol Fumarate IH
Tiotropium Bromide
Monohydrate IH

0.013 mg
0.025 mg

18

Acyclovir BP

200 mg

36
month
s

Terbinafine Hydrochloride
IH

250 mg

36

Cipla Ltd.
INDIA

Fluticasone Propionate BP

50 mcg

24

Cipla Ltd.
INDIA

Tamsulosin Hydrochloride
IH

400 mcg

24

Cipla Ltd.
INDIA

Tamsulosin Hydrochloride
IH

400 mcg

24

Cipla Ltd.
INDIA

Clarithromycin USP

500 mg

36

Cipla Ltd.
INDIA

Acivir,Tablet
Cipla Ltd.
INDIA

Terbifin,Tablet

Flomist,Spray

Urimax,Capsules

Urimax,Capsules

Synclar,Tablet

Page 107 of 584

Human Medicinal Products


S/No:

683.

684.

685.

686.

Registration Number

TAN 07,463 D01B CIP

TAN 07,461 D01A CIP

TAN 07,460 V07A CIP

TAN 00,1014 A04A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

688.

689.

TAN 00,1370 A04A CIP

TAN 00,1577 J05A CIP

TAN 00,4446 J01D CIP

Manufacturer

Terbifin,Cream

Terbinafine Hydrochloride
IH

1 %w/w

24

Cipla Ltd.
INDIA

Nystatin USP

500000 IU

24

Cipla Ltd.
INDIA

Fenofibrate BP

200 mg

30

Cipla Ltd.
INDIA

24

Cipla Ltd.
INDIA

Nystatin,Tablet

Fenolip,Capsules

Emeset,Solution

Ondansentron
2 mg/ml
Hydrochloride Dihydrate IP

687.

Shelf life
month

Emeset,Injectable Solution

Ondansentron
Hydrochloride Dihydrate
USP

2 mg/ml

24

Cipla Ltd.
INDIA

Acyclovir BP

200 mg

36

Cipla Ltd.
INDIA

Cefadroxil Anhydrous
equivalent to Cefadroxil
USP

500 mg

24

OSCAR ERNEST MGIMBE


TANZANIA

Acivir DT,Tablet

Cefadur,Capsules

Page 108 of 584

Human Medicinal Products


S/No:

690.

691.

692.

693.

694.

695.

696.

Registration Number

TAN 07,152 B01A CIP

TAN 08,035 G03H CIP

TAN 08,036 D01A CIP

TAN 08,034 J05A CIP

TAN 00,1565 J05C CIP

TAN 00,1771 B01A CIP

TAN 00,1772 D01B CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Clopivas AP 150,Tablet

Acetylsalicylic Acid BP
Clopidogrel Bisulfate USP

150 mg
97.85 mg

24

OSCAR ERNEST MGIMBE


TANZANIA

Flutamide USP

250 mg

36

Cipla Ltd.
INDIA

Nystatin USP

100000 IU

24

Cipla Ltd.
INDIA

Lamivudine USP
Stavudine USP

30 mg
6 mg

24

Cipla Ltd.
INDIA

Stavudine IH

30 mg

24

Cipla Ltd.
INDIA

Warfarin Sodium USP

5 mg

36

Cipla Ltd.
INDIA

2 mg/ml

24

Cipla Ltd
INDIA

Cytomid,Tablet

Nystatin,Tablet

Lamivir-S,Tablet

Stavir,Capsules

Warf,Tablet

Forcan IV,Injectable Solution

Fluconazole IH

Page 109 of 584

Human Medicinal Products


S/No:

697.

Registration Number

TAN 08,132 J05A CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

699.

700.

701.

702.

703.

TAN 08,131 J05A CIP

TAN 08,130 J05A CIP

TAN 08,129 J05A CIP

TAN 08,128 J05A CIP

TAN 00,4083 J05A CIP

TAN 00,4079 J05A CIP

Manufacturer

Efavirenz,Tablet
600 mg

24

Cipla Ltd.
INDIA

Lamivudine USP
Stavudine USP

150 mg
30 mg

24

Cipla Ltd.
INDIA

Nevirapine USP

200 mg

24

Cipla Ltd.
INDIA

Lamivudine USP

10 mg/ml

18

Cipla Ltd.
INDIA

Abacavir Sulphate IH

300 mg

24

Cipla Ltd.
INDIA

Didanosine IH

200 mg

24

Cipla Ltd.
INDIA

Didanosine IH

100 mg

24

Cipla Ltd.
INDIA

Efavirenz IH

698.

Shelf life
month

Lamivir S 30,Tablet

Nevirapine,Tablet

Lamivudine,Solution

Abacavir,Tablet

Divir,Tablet

Divir,Tablet

Page 110 of 584

Human Medicinal Products


S/No:

704.

Registration Number

TAN 00,4354 N04C CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 09,010 B01A CIP

24

Cipla Ltd.
INDIA

24

Cipla Ltd.
INDIA

Enoxaparin Sodium Ph Eur 60 mg/0.6ml

24

Cipla Ltd.
INDIA

Stavudine USP

1 mg/ml

24

Cipla Ltd.
INDIA

Tadalafil IH

20 mg

24

Cipla Ltd.
INDIA

Lisinopril USP

5 mg

24

Cipla Ltd.
INDIA

55 mg/ml

24

Cipla Ltd.
INDIA

0.5 mg

Enclex,Injectable Solution

Enoxaparin Sodium Ph Eur 40 mg

706.

707.

708.

709.

710.

TAN 09,011 B01A CIP

TAN 09,040 J05A CIP

TAN 08,127 C04A CIP

TAN 10,007 C01E

TAN 05,095 L01C CIP

Manufacturer

Restyl,Tablet

Alprazolam IP

705.

Shelf life
month

Enclex,Injectable Solution

Stavir,Syrup

Tadacip-20,Tablet

Cipril,Tablet

Oncodox,Injectable Solution

Doxorubicin Hydrochloride
USP

Page 111 of 584

Human Medicinal Products


S/No:

711.

Registration Number

TAN 10,053 R03A

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 10,056 C01K

36

Cipla Ltd.
INDIA

2.5 mg

24

IPCA Laboratories Ltd.


INDIA

500 mg
4g

24

Cipla Ltd.
INDIA

20 mg/ml

24

Cipla Ltd.
INDIA

30 mg
200 mg
150 mg

24

Cipla Ltd.
INDIA

300 mg
150mg + 12.5mg mg

24

Cipla Ltd.
INDIA

100 mg

24

Cipla Ltd.
INDIA

Ramipres 2.5,Tablet

Ramipril BP

713.

TAN 10, 055 J01C

Tazact,Powder for Injection

Tazobactum Sodium IH
Piperacillin Sodium IH

714.

TZ10H002

Abacavir Sulfate,Oral Solution


20mg/ml

Abacavir Sulphate eq to
Abacavir IH

715.

TZ10H023

Lamivudine 150+ Stavudine


30 + Nevirapine 200,Tablet

Stavudine IH
Nevirapine IH
Lamivudine IH

716.

TZ10H026

Zidovudine
300mg+Lamivudine150mg,Ta
Zidovudine IH
blet

Lamivudine IH

717.

TZ10H024

Manufacturer

Asthalin,Inhaler

Salbutamol Sulphate
107.5 mcg
equivalent to Salbutamol BP

712.

Shelf life
month

Zidovudine 100mg,Capsules

Zidovudine IH

Page 112 of 584

Human Medicinal Products


S/No:

718.

719.

720.

721.

722.

723.

724.

Registration Number

TZ10H087

TZ10H088

TZ10H089

TZ10H090

TZ10H091

TAN 05,470 L01C CIP

TAN 05,609 J05A CIP

Product Name
Pack and Pack size
Budecort 200 CFC
Free,Inhaler

Budecort 100 CFC


Free,Aerosol

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Budesonide BP

200 mcg

36

Cipla Ltd.
INDIA

Budesonide BP

100 mcg

36

Cipla Ltd.
INDIA

Povidine BP
Polyvinyl Alcohol USP

6 mg
14 mg

24

Cipla Ltd.
INDIA

Cytarabine BP

100 mg/ml

24

Cipla Ltd.
INDIA

Cytarabine BP

500 mg/5ml

24

Cipla Ltd.
INDIA

Vincristine Sulphate USP

1 mg/ml

18

Cipla Ltd.
INDIA

Efavirenz IH

200 mg

24

Cipla Ltd.
INDIA

Aqua Tears,Solution

Cytabine,Injection

Cytabine,Injection

Cytocristin,Injection

Efavir,Capsules

Page 113 of 584

Human Medicinal Products


S/No:

725.

726.

727.

728.

729.

730.

731.

Registration Number

TAN 05,609 J05A CIP

TAN 05,622 R03A CIP

TAN 05,622 R03A CIP

TAN 05,594 A04A CIP

TAN 05,594 A04A CIP

TAN 05,473 C01K CIP

TAN 05,473 C01K CIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Efavir,Capsules

Efavirenz IH

200 mg

24

Cipla Ltd.
INDIA

Budesonide BP

1 mg/2ml

24

Cipla Ltd.
INDIA

Budesonide BP

1 mg/2ml

24

Cipla Ltd.
INDIA

Ondansetron Hydrochloride 4 mg
eq to Ondansetron USP

36

Cipla Ltd.
INDIA

Ondansetron Hydrochloride 4 mg
eq to Ondansetron USP

36

Cipla Ltd.
INDIA

Amlodipine Besylate IH

5 mg

36

Cipla Ltd.
INDIA

Amlodipine Besylate IH

5 mg

36

Cipla Ltd.
INDIA

Budecort,Respules

Budecort,Respules

Emeset,Tablet

Emeset,Tablet

Amlopres,Tablet

Amlopres,Tablet

Page 114 of 584

Human Medicinal Products


S/No:

732.

733.

734.

735.

Registration Number

TAN 05,603 J05A CIP

TAN 05,605 J05A CIP

TAN 05,627 J05A CIP

TAN 10,056 C01K

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,752 V07A CIP

Lamivudine IH

50 mg/ml

24

Cipla Ltd.
INDIA

Stavudine IH

30 mg

24

Cipla Ltd.
INDIA

Nevirapine IH
Zidovudine USP
Lamivudine IH

200 mg
300 mg
150 mg

24

Cipla Ltd.
INDIA

2.5 mg

24

IPCA Laboratories Ltd.


INDIA

1 mg/10ml

24

Cipla Ltd.
INDIA

Docetaxel Trihydrate
equivalent to Docetaxel IH

20 mg/5ml

24

Cipla Ltd.
INDIA

Tenofovir Disoproxil
Fumarate INH
Emtricitabine INH

300 mg

24

Cipla Ltd.
INDIA

Stavir,Capsules

Duovir N,Tablet

Ramipres 2.5,Tablet

Cytoblastin,Injection

Vinblastine Sulphate USP

737.

738.

TAN 05,751 L01X CIP

TZ11H166

Manufacturer

Lamivir,Solution

Ramipril BP

736.

Shelf life
month

Docetax-20,Injectable
Solution

Tenvir-EM,Tablet

Page 115 of 584

200 mg

Human Medicinal Products


S/No:

739.

Registration Number

TZ11H162

Product Name
Pack and Pack size

Ingredient(s) and Strength

Tenofovir Disoproxil
Fumarate 300mg,Tablet

Tenofovir Disoproxil
Fumarate IH

740.

TZ11H182

741.

TAN 07,159 B05B CLA

TAN 05,069 P01A CLA

D480

D480

500 mg/ml

24
Month
s

0.9 %

36

Claris Lifesciences Ltd.


INDIA

0.5 %w/v

36

Claris Lifesciences Ltd.


INDIA

10 mg

24

Claris Lifesciences Ltd.


INDIA

10 mg

24

Claris Lifesciences Ltd.


INDIA

Cipla Ltd.
INDIA

Metris,Injectable Solution

PROVIVE,Injectable Solution

Propofol BP

744.

24

Sodium Chloride,Solution

Metronidazole USP

743.

Cipla Ltd.
INDIA

300 mg

Claris Lifesciences Ltd. - INDIA


Sodium Chloride BP

742.

Manufacturer

Amicip 500,Injection

Amikacin BP

Registrant

Shelf life
month

NUROFEN,Injectable Solution

Propofol BP

Page 116 of 584

Human Medicinal Products


S/No:

745.

Registration Number

TAN 05,155 B01A CLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,154 N01A CLA

24

Claris Lifesciences Ltd.


INDIA

24

Claris Lifesciences Ltd.


INDIA

1 mg/5ml

24

Claris Lifesciences Ltd.


INDIA

Tramadol Hydrochloride BP 50 mg/ml

24

Claris Lifesciences Ltd.


INDIA

5 mg/ml

24

Claris Lifesciences Ltd.


INDIA

6 %w/v

36

Claris Lifesciences Ltd.


INDIA

5 mg/ml

24

Claris Lifesciences Ltd.


INDIA

5000 IU/ml

Ketajex,Injectable Solution

Ketamine Hydrochloride BP 50 mg/ml

747.

TAN 05,153 N04B CLA

Sedoz,Injectable Solution

Midazolam BP

748.

749.

TAN 05,152 N02B CLA

TAN 05,151 A04A CLA

Tamadol,Injectable Solution

Remitin,Injectable Solution

Metoclopramide
Hydrochloride BP

750.

TAN 06,270 V07A CLA

Hestar-200,Injectable
Solution

Hydroxyethyl starch IH

751.

TAN 05,756 N01B CLA

Manufacturer

Heparen,Injectable Solution

Heparin Sodium BP

746.

Shelf life
month

Bupican Heavy,Injection

Bupivacaine hydrochloride
BP

Page 117 of 584

Human Medicinal Products


S/No:

752.

Registration Number

TAN 05,755 V07A CLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Celemin 10 Plus,Injectable
Solution

L-Histidine Hydrochloride
BP
Sodium Acetate BP
L-Glutamic acid BP
L-Aspartic acid BP
L-Ornithine Hydrochloride
BP
Potassium Acetate BP
Magnesium Acetate BP
L- Cystine BP
L-Serine IH
L-Malic acid IH
L-Isoleucine USP
L-Leucine USP
L-Phenylalanine USP
L-Threonine USP
L-Tryptophan USP
L-Valine USP
L-Lysine Hydrochloride USP
L-Methionine USP
L-Proline USP
L-Tyrosine USP
Glycine USP
L-Asparagine USP
Acetyltyrosine USP
Sodium Dihydrogen
Phosphate USP
L - Arginine Hydrochloride
USP
L - Alamine USP

753.

TAN 05,754 N01B CLA

0.25 g

Shelf life
month

Manufacturer

24

Claris Lifesciences Ltd.


INDIA

36

Claris Lifesciences Ltd.


INDIA

0.395 g
0.075 g
0.25 g
0.32 g
0.345 g
0.056 g
0.01 g
0.025 g
0.1 g
0.352 g
0.49 g
0.533 g
0.25 g
0.09 g
0.360 g
0.43 g
0.225 g
0.10 g
0.025 g
0.76 g
0.372 g
0.123 g
0.14 g
0.5 g
0.2 g

Bupican,Injectable Solution

Bupivacaine hydrochloride
BP

Page 118 of 584

0.5 %w/v

Human Medicinal Products


S/No:

754.

Registration Number

TAN 06,270 V07A CLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Hestar-200,Injectable
Solution

TAN 06,385 P01A CLA

36

Claris Lifesciences Ltd.


INDIA

5 %w/v

36

Claris Lifesciences Ltd.


INDIA

Ciprofloxacin USP

0.02 %w/v

36

Claris Lifesciences Ltd.


INDIA

Glucose BP
Sodium Chloride BP

5 %w/v
0.9 %w/v

36

Claris Lifesciences Ltd.


INDIA

Glucose BP

50 g/L

36

Claris Lifesciences Ltd.


INDIA

Glucose BP

50 g/L

36

Claris Lifesciences Ltd.


INDIA

Calcium Chloride BP
Sodium Chloride BP
Sodium Lactate BP
Potassium Chloride BP

0.02 g/100ml
0.6 g/100ml
0.320 g/100ml
0.04 g/100ml

36

Claris Lifesciences Ltd.


INDIA

Metris,Injectable Solution

Metronidazole USP

756.

757.

758.

759.

760.

TAN 06,384 J01K CLA

TAN 06,382 B05B CLA

TAN 07,163 B05B CLA

TAN 07,157 B05B CLA

TAN 07,158 A12C CLA

Manufacturer

6 %w/v

Hydroxyethyl starch IH

755.

Shelf life
month

Ciprox,Injectable Solution

Sodium Chloride +
Glucose,Solution

Glucose,Solution

Glucose,Solution

Compound Sodium
Lactate,Solution

Page 119 of 584

Human Medicinal Products


S/No:

761.

Registration Number

TAN 07,161 B05B CLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 07,162 J02A CLA

0.9 %w/v

36

Claris Lifesciences Ltd.


INDIA

200 mg/100ml

36

Claris Lifesciences Ltd.


INDIA

Soya Bean Oil USP

20 g/100ml

36

Claris Lifesciences Ltd.


INDIA

Calcium Chloride BP
Sodium Chloride BP
Sodium Lactate BP
Potassium Chloride BP

0.02 g/100ml
0.6 g/100ml
0.320 g/100ml
0.04 g/100ml

36

Claris Lifesciences Ltd.


INDIA

5 %w/v

36

Claris Lifesciences Ltd.


INDIA

10 mg

24

Claris Lifesciences Ltd.


INDIA

1g

24

Claris Lifesciences Ltd.


INDIA

Fluconazole,Solution

Fluconazole BP

763.

764.

765.

TAN 07,160 V06D CLA

TAN 07,164 A12C CLA

TAN 05,069 P01A CLA

Celepid 20%,Emulsion

Compound Sodium
Lactate,Solution

Metris,Injectable Solution

Metronidazole USP

766.

D480

PROVIVE,Injectable Solution

Propofol BP

767.

TAN 10, 054 J01D CL

Manufacturer

Sodium Chloride,Solution

Sodium Chloride BP

762.

Shelf life
month

Curaxone,Powder for Injection

Ceftriaxone Sodium eq to
Ceftriaxone USP

Page 120 of 584

Human Medicinal Products


S/No:

768.

Registration Number

TAN 05,155 B01A CLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,756 N01B CLA

Manufacturer

Heparen,Injectable Solution

Heparin Sodium BP

769.

Shelf life
month

5000 IU/ml

24

Claris Lifesciences Ltd.


INDIA

5 mg/ml

24

Claris Lifesciences Ltd.


INDIA

Bupican Heavy,Injection

Bupivacaine hydrochloride
BP

Page 121 of 584

Human Medicinal Products


S/No:

770.

Registration Number

TAN 05,755 V07A CLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Celemin 10 Plus,Injectable
Solution

L-Histidine Hydrochloride
BP
Sodium Acetate BP
L-Glutamic acid BP
L-Aspartic acid BP
L-Ornithine Hydrochloride
BP
Potassium Acetate BP
Magnesium Acetate BP
L- Cystine BP
L-Serine IH
L-Malic acid IH
L-Isoleucine USP
L-Leucine USP
L-Phenylalanine USP
L-Threonine USP
L-Tryptophan USP
L-Valine USP
L-Lysine Hydrochloride USP
L-Methionine USP
L-Proline USP
L-Tyrosine USP
Glycine USP
L-Asparagine USP
Acetyltyrosine USP
Sodium Dihydrogen
Phosphate USP
L - Arginine Hydrochloride
USP
L - Alamine USP

771.

TAN 05,754 N01B CLA

Manufacturer

24

Claris Lifesciences Ltd.


INDIA

36

Claris Lifesciences Ltd.


INDIA

0.395 g
0.075 g
0.25 g
0.32 g
0.345 g
0.056 g
0.01 g
0.025 g
0.1 g
0.352 g
0.49 g
0.533 g
0.25 g
0.09 g
0.360 g
0.43 g
0.225 g
0.10 g
0.025 g
0.76 g
0.372 g
0.123 g
0.14 g
0.5 g
0.2 g

Bupican,Injectable Solution

Bupivacaine hydrochloride
BP

Registrant

0.25 g

Shelf life
month

0.5 %w/v

CNCCC Sichuan IMP/EXP Co.Ltd. - CHINA

Page 122 of 584

Human Medicinal Products


S/No:

772.

Registration Number

TAN 07,607 M01A CNC

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 07,166 J01K CNC

TAN 07,165 J01D CNC

75 mg/3ml

36

500 mg/2ml

36

Ceftriaxone Sodium,Powder
for Injection

Ceftriaxone Sodium
1g
equivalent to Ceftriaxone BP

775.

TAN 07,606 H02A CNC

Dexamethasone,Injectable
Solution

Dexamethasone Sodium
Phosphate BP

776.

TAN 09,278 J02A CNC

Fluconazole,Injectable
Solution

Fluconazole USP

777.

TAN 09,277 P01B CNC

Quinine
Dihydrochloride,Injectable
Quinine Dihydrochloride
Solution

BP

Registrant

Leshan Sanjiu-LongMarch
Pharmaceutical Co. Ltd
CHINA

Amikan,Injectable Solution

Amikacin Sulphate BP

774.

Manufacturer

Diclofenac,Injectable Solution

Diclofenac Sodium BP

773.

Shelf life
month

Codal Syntho Ltd - CYPRUS

Page 123 of 584

24

80 mg/2ml

36

2.0 mg/ml

24

300 mg/ml

36

Leshan Sanjiu-LongMarch
Pharmaceutical Co. Ltd
CHINA

Harbin Pharmaceutical
Group Co.Ltd.
CHINA

Leshan Sanjiu-LongMarch
Pharmaceutical Co. Ltd
CHINA

Sichuan Kelun
Pharmaceutical Factory
CHINA

Wuhan Grand
Pharmaceuticals Group Co.,
Ltd.
CHINA

Human Medicinal Products


S/No:

778.

779.

780.

781.

782.

783.

784.

Registration Number

TAN 06,272 N02B COD

TAN 06,275 M01A COD

TAN 06,273 J01D COD

TAN 06,278 J01D COD

TAN 06,276 J01D COD

TAN 06,271 J01H COD

TAN 06,277 J01H COD

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Rofy,Powder for Injection

Tramadol Hydrochloride Ph 50 mg/ml


Eur

24

Medochemie Ltd.
CYPRUS

Diclofenac Sodium Ph Eur

60

Medochemie Ltd.
CYPRUS

Ceftriaxone Sodium Ph Eur 250 mg/vial

24

Medochemie Ltd.
CYPRUS

Ceftriaxone Sodium Ph Eur 500 mg/vial

24

Medochemie Ltd.
CYPRUS

Ceftriaxone Ph Eur

1g

24

Medochemie Ltd.
CYPRUS

Ampicillin BP

250 mg

48

Medochemie Ltd.
CYPRUS

Ampicillin Sodium
equivalent to Ampicillin Ph
Eur

500 mg

48

Medochemie Ltd.
CYPRUS

Taks,Tablet
50 mg

Ceftrix,Injection

Ceftrix,Injection

Ceftrix,Injection

Syntocil,Injection

Syntocil,Injection

Page 124 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
785.

TAN 09,279 P02X COL

Product Name
Pack and Pack size

Ingredient(s) and Strength

786.

TAN 07,465 COO

Mebencol,Tablet

TAN 07,030 R03A COO

36

0.2206 g/L
15.45 g/L
5.553 g/L
0.1016 g/L
4.762 g/L

36

Cooper S.A.
GREECE

25 mg

36

Cooper S.A.
GREECE

Tetracaine Hcl Ph Eur

5 %w/v

24

Cooper S.A.
GREECE

Sodium Phosphate Dibasic


Heptahydrate Ph Eur

60 mg

24

Cooper S.A.
GREECE

2.5 mg

24

Cooper S.A.
GREECE

Cooper S.A. - GREECE


Peritoneal Cooper,Solution

Aminophylline,Injectable
Solution

Aminophylline USP

788.

789.

790.

TAN 07,031 S01A COO

TAN 07,019 A06A COO

TAN 07,020 N06A COO

Osaka Pharmaceuticals Pvt.


Lts
INDIA

100 mg

Calcium Chloride Ph Eur


Glucose Ph Eur
Sodium Chloride Ph Eur
Magnesium Chloride Ph Eur
Sodium Acetate Ph Eur
787.

Manufacturer

Colorama Pharmaceuticals - UNITED KINGDOM


Mebendazole USP

Registrant

Shelf life
month

Tetracaine,Ophthalmic
Solution

Enema,Solution

Neostigmine,Injectable
Solution

Neostigmine Methyl
Sulphate Ph Eur

Page 125 of 584

Human Medicinal Products


S/No:

791.

Registration Number

TAN 07,021 COO

Product Name
Pack and Pack size

Ingredient(s) and Strength

Phenylephrine,Ophthalmic
Solution

Phenylephrine
Hydrochloride Ph Eur

792.

TAN 07,022 S01A COO

Sulfacetamide,Ophthalmic
Solution

Sulfacetamide Sodium Ph
Eur

793.

TAN 07,023 N04A COO

TAN 07,024 J01B COO

Sulfanicole,Ophthalmic
Solution

Sulfacetamide Sodium Ph
Eur
Chloramphenicol Sodium
Succinate equivalent to
Chloramphenicol Ph Eur

795.

TAN 07,025 J01H COO

Copercilex,Ophthalmic
Solution

Ampicillin Sodium
equivalent to Ampicillin Ph
Eur

796.

TAN 07,026 S01D COO

Iodocollyre,Ophthalmic
Solution

Sodium Iodide Ph Eur


Calcium Chloride
Hexahydrate Ph Eur

797.

TAN 07,027 S01D COO

Manufacturer

5%

24

Cooper S.A.
GREECE

10 %

24

Cooper S.A.
GREECE

500 mg

36

Cooper S.A.
GREECE

100 mg/ml

36

Cooper S.A.
GREECE

1.5 %

36

Cooper S.A.
GREECE

20 mg
20 mg

24

Cooper S.A.
GREECE

2%

36

Cooper S.A.
GREECE

Lycitrope,Injectable Solution

Suxamethonium Chloride
Ph Eur

794.

Shelf life
month

Pilocollyre,Ophthalmic
Solution

Pilocarpine Hydrochloride
Ph Eur

Page 126 of 584

50 mg/ml

Human Medicinal Products


S/No:

798.

Registration Number

TAN 07,028 S01D COO

Product Name
Pack and Pack size

Ingredient(s) and Strength

Fluroptic,Ophthalmic
Solution

TAN 07,029 S01D COO

Cooper S.A.
GREECE

36

Cooper S.A.
GREECE

3 mg

24

Cooper S.A.
GREECE

1%

24

Cooper S.A.
GREECE

36

Cooper S.A.
GREECE

4 %w/v

36

Cooper S.A.
GREECE

1 %w/v

36

Cooper S.A.
GREECE

Septobore,Ophthalmic
Solution

Naphazoline Nitrate Ph Eur 1 mg


10 mg
Boric Acid Ph Eur

800.

TAN 07,170 J01K COO

Eyetobrin,Ophthalmic
Solution

Tobramycin Sulphate Ph
Eur

801.

TAN 07,018 A03B COO

Atropine,Ophthalmic Solution

Atropine Sulphate Ph Eur

802.

TAN 07,172 B05B COO

Dextrose,Solution

Glucose Anhydrous Ph Eur 50 %w/v

803.

TAN 07,168 S01A COO

Allergotin,Ophthalmic
Solution

Cromoglicate Sodium Ph
Eur

804.

TAN 07,169 H02A COO

Manufacturer

24

Flurbiprofen Sodium Ph Eur 0.03 mg

799.

Shelf life
month

Adelone,Ophthalmic Solution

prednisolone sodium
phosphate Ph Eur

Page 127 of 584

Human Medicinal Products


S/No:

805.

Registration Number

TAN 07,171 B05B COO

Product Name
Pack and Pack size

Ingredient(s) and Strength

807.

TAN 07,167 B05B COO

TAN 07,464 J01K COO

Registrant
808.

TAN 05,098 V07A COR

36

Cooper S.A.
GREECE

5 %w/v
Dextrose Ph Eur
Potassium Chloride Ph Eur 0.2 %w/v

36

Cooper S.A.
GREECE

Ciprofloxacin Ph Eur

3.5 mg/ml

36

Cooper S.A.
GREECE

10 ml

18

Core Healthcare Ltd.


INDIA

809.

810.

TAN 06,393 D07A COS

Clobetasol Propionate BP

0.05 %w/w

18

Cosme Pharma Ltd


INDIA

TAN 06,392 D06A COS

Sodium Fusidate BP

2 %w/w

24

Cosme Pharma Ltd


INDIA

20 %w/v

Potassium Chloride with


dextrose,Solution

Nafloxin,Solution

Core Healthcare Ltd. - INDIA


Water For Injection,Liquid

Water for Injection BP

Registrant

Manufacturer

Mannitol,Injectable Solution

Mannitol Ph Eur

806.

Shelf life
month

Cosme Pharma Ltd - INDIA


Cosvate,Cream

Futop,Ointment

Page 128 of 584

Human Medicinal Products


S/No:

811.

Registration Number

TAN 06,391 D01A COS

Product Name
Pack and Pack size

Ingredient(s) and Strength

813.

814.

815.

816.

TAN 06,390 COS

TAN 06,389 D01A COS

TAN 06,388 M01A COS

TAN 06,394 D07X COS

TAN 07,173 A04A COS

24

Cosme Pharma Ltd


INDIA

0.005 %w/w
Clobetasol Propionate BP
Gentamicin Sulphate
0.1 %w/w
equivalent to Gentamicin BP

18

Cosme Pharma Ltd


INDIA

Benzoyl Peroxide BP

2.5 %w/w

24

Cosme Pharma Ltd


INDIA

Salicylic Acid BP
Flufenamic Acid IH
Mucopolysaccharide
Polysulfate IH

20 mg
30 mg
2 mg

24

Cosme Pharma Ltd


INDIA

Clobesol Propionate BP
Miconazole Nitrate INP
Gentamicin INP

0.05 %w/w
2 %w/w
0.1 %w/w

18

Cosme Pharma Ltd


INDIA

10 mg/2ml

24

Cosme Pharma Ltd


INDIA

TAN 07,175 B02B COS

250 mg/2ml

36

Cosme Pharma Ltd


INDIA

5 %w/w

Cosvate-G,Cream

Pernex AC,Gel

Movelisin,Gel

Cosvate-GM,Cream

Metoclopramide,Injectable
Solution

Metoclopramide
Hydrochloride BP

817.

Manufacturer

Pernex AC,Gel

Benzoyl Peroxide BP

812.

Shelf life
month

Cosklot,Injectable Solution

Etamsylate BP

Page 129 of 584

Human Medicinal Products


S/No:

818.

819.

820.

Registration Number

TAN 07,174 B03A COS

TAN 06,394 D07X COS

TAN 06,390 COS

Product Name
Pack and Pack size

Ingredient(s) and Strength

821.

822.

823.

TAN 00,4092 A10B COS

TAN 00,4457 J01D COS

TAN 00,4450 A03B COS

Manufacturer

Jectocos,Injectable Solution

Iron Sorbitol Dextrin IH

300 mg/ml

36

Cosme Pharma Ltd


INDIA

Clobesol Propionate BP
Miconazole Nitrate INP
Gentamicin INP

0.05 %w/w
2 %w/w
0.1 %w/w

18

Cosme Pharma Ltd


INDIA

18

Cosme Pharma Ltd


INDIA

Metformin Hydrochloride BP 500 mg

24

Cosmos Ltd.
KENYA

Cefaclor USP

125 mg/5ml

24

Cosmos Ltd.
KENYA

Hyoscine Butylbromide BP

10 mg

24

Cosmos Ltd.
KENYA

Cosvate-GM,Cream

Cosvate-G,Cream
0.005 %w/w
Clobetasol Propionate BP
Gentamicin Sulphate
0.1 %w/w
equivalent to Gentamicin BP

Registrant

Shelf life
month

Cosmos Ltd. - KENYA


Glucomet,Tablet

Cosclor,Powder

Hyoscine,Tablet

Page 130 of 584

Human Medicinal Products


S/No:

824.

825.

826.

827.

828.

829.

830.

Registration Number

TAN 00,4455 A02A COS

TAN 00,4451 P02A COS

TAN 00,4456 P01B COS

TAN 00,4452 C03C COS

TAN 05,018 C01K COS

TAN 05,019 C01K COS

TAN 05,017 C01K COS

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Cosmag,Tablet

Aluminium Hydroxide BP
Magnesium Trisilicate BP

120 mg
250 mg

60

Cosmos Ltd.
KENYA

Praziquantel USP

600 mg

36

Cosmos Ltd.
KENYA

Pyrimethamine USP
Sulfamethopyrazine USP

25 mg
500 mg

36

Cosmos Ltd.
KENYA

Frusemide BP

40 mg

48

Cosmos Ltd.
KENYA

Atenolol BP

25 mg

36

Cosmos Ltd.
KENYA

Atenolol BP

50 mg

24

Cosmos Ltd.
KENYA

Atenolol BP

100 mg

36

Cosmos Ltd.
KENYA

Prazitel,Tablet

Kelfalin,Tablet

Frusemide,Tablet

Cardinol,Tablet

Cardinol,Tablet

Cardinol,Tablet

Page 131 of 584

Human Medicinal Products


S/No:

831.

832.

833.

834.

835.

836.

837.

Registration Number

Product Name
Pack and Pack size

TAN 05,099 H02A COS

Prednisolone,Tablet

TAN 05,100 C03A COS

TAN 07,033 D01A COS

TAN 00,1373 J05A COS

TAN 00,1379 N04A COS

TAN 00,1374 P02A COS

TAN 00,1375 J01H COS

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Prednisolone BP

5 mg

36

Cosmos Ltd.
KENYA

Bendrofluazide BP

5 mg

60

Cosmos Ltd.
KENYA

Nystatin BP

100000 IU

36

Cosmos Ltd.
KENYA

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

60

Cosmos Ltd.
KENYA

Diazepam BP

5 mg

60

Cosmos Ltd.
KENYA

Quinine Bisulphate
equivalent to Quinine BP

300 mg

48

Cosmos Ltd.
KENYA

36

Cosmos Ltd.
KENYA

Benduric,Tablet

Nycostat,Lozenges

Cosatrim,Tablet

Cozepam,Tablet

Quini,Tablet

Camox,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

Page 132 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

838.

TAN 00,1380 D01A COS

Nycostat,Suspension

Ingredient(s) and Strength

TAN 00,1378 N02B COS

36

Cosmos Ltd.
KENYA

30 mg

60

Cosmos Ltd.
KENYA

Salbutamol Sulphate
4 mg
equivalent to Salbutamol BP

48

Cosmos Ltd.
KENYA

Pyrimethamine USP
Sulfadoxine USP

25 mg
500 mg

48

Cosmos Ltd.
KENYA

Chlorpheniramine Maleate
BP
Ephedrine Hydrochloride
BP
Menthol BP
Sodium Citrate BP
Ammonium Chloride BP
Glyceryl Guaiacolate IH

2 mg/5ml

36

Cosmos Ltd.
KENYA

Loratadine IH

10 mg

36

Cosmos Ltd.
KENYA

Phenobarbital,Tablet

Phenobarbital BP

840.

841.

842.

843.

TAN 00,1382 C06A COS

TAN 00,1383 P01B COS

TAN 00,2120 R02A COS

TAN 00,2539 D04A COS

Manufacturer

100000 IU/ml

Nystatin BP

839.

Shelf life
month

Salbut,Tablet

Falcidin,Tablet

Coscof,Syrup

8 mg/5ml
1.1 mg/5ml
44 mg/5ml
100 mg/5ml
80 mg/5ml

Lorhistina,Tablet

Page 133 of 584

Human Medicinal Products


S/No:

844.

845.

846.

Registration Number

TAN 00,2538 P01A COS

TAN 00,4450 A03B COS

TAN 05,099 H02A COS

Product Name
Pack and Pack size

Ingredient(s) and Strength

847.

848.

849.

TAN 00,656 C03A CPP

TAN 05,168 J05A CP

TAN 00,656 C03A CPP

Manufacturer

Metrozol,Tablet

Metronidazole BP

200 mg

60

Cosmos Ltd.
KENYA

Hyoscine Butylbromide BP

10 mg

24

Cosmos Ltd.
KENYA

36

Cosmos Ltd.
KENYA

Hyoscine,Tablet

Prednisolone,Tablet

Prednisolone BP

Registrant

Shelf life
month

CP Pharmaceuticals Ltd - UNITED KINGDOM


Frusemide,Tablet

Frusemide Ph Eur

40 mg

36

Wockhardt UK Ltd.
UNITED KINGDOM

Acyclovir Ph Eur

200 mg

36

CP Pharmaceuticals Ltd
UNITED KINGDOM

Frusemide Ph Eur

40 mg

36

Wockhardt UK Ltd.
UNITED KINGDOM

Aciclovir,Tablet

Frusemide,Tablet

Page 134 of 584

Human Medicinal Products


S/No:

850.

851.

852.

853.

Registration Number

TAN 00,657 C06A CPP

TAN 00,658 C06A CPP

TAN 00,661 A10B CPP

A569/2005/1

Registrant
854.

TAN 09,124 M01A CRO

Product Name
Pack and Pack size

Ingredient(s) and Strength

855.

TAN 00,1967 P01B DAF

Manufacturer

Totamol,Tablet

Atenolol Ph Eur

50 mg

24

CP Pharmaceuticals Ltd
UNITED KINGDOM

Atenolol Ph Eur

100 mg

24

CP Pharmaceuticals Ltd
UNITED KINGDOM

Glibenclamide Ph Eur

5 mg

24

Wockhardt UK Ltd.
UNITED KINGDOM

Atenolol Ph Eur

25 mg

36

CP Pharmaceuticals Ltd
UNITED KINGDOM

200 mg

36

Crookes Healthcare Ltd.


UNITED KINGDOM

80 mg/ml

48

Rotexmedica GMBH
GERMANY

Totamol,Tablet

Glibenclamide,Tablet

Totamol,Tablet

Crookes Healthcare Ltd. - UNITED KINGDOM


Nurofen,Tablet

Ibuprofen Ph Eur

Registrant

Shelf life
month

DAFRA PHARMA - KENYA


Artesiane,Injection

B-artemether IP

Page 135 of 584

Human Medicinal Products


S/No:

856.

Registration Number

TAN 05,745 J01D BIL

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,745 J01D BIL

TAN 05,750 J01C BIL

TAN 00,1968 P01B DAF

Artemether
Paediatric,Injectable Solution

B-artemether IH
Beta Arthemether IP

860.

TAN 00,1968 P01B DAF

Artemether
Paediatric,Injectable Solution

B-artemether IH
Beta Arthemether IP

Registrant

24

Bilim Pharmaceuticals A.S,


TURKEY

1000 mg

24

Bilim Pharmaceticals A.S,


TURKEY

24

Bilim Pharmaceticals A.S,


TURKEY

20 mg/ml
20 mg

36

Rotexmedica GMBH
GERMANY

20 mg/ml
20 mg

36

Rotexmedica GMBH
GERMANY

1000 mg

Dafraclav,Suspension

Amoxycillin Trihydrate Ph
Eur
Clavulanic Acid Ph Eur
Clavulanate Potassium Ph
Eur
Amoxicillin Trihydrate
equivalent to Amoxicillin Ph
Eur
859.

1000 mg

Forsef,Powder for Injection

Ceftriaxone Disodium Ph
Eur
Ceftriaxone Disodium
Trihydrate equivalent to
Ceftriaxone Ph Eur
858.

Manufacturer

Cetafor,Powder for Injection

Ceftriaxone Disodium
Trihydrate equivalent to
Ceftriaxone Ph Eur
857.

Shelf life
month

Dafra Pharma Ltd. - KENYA

Page 136 of 584

200 mg/5ml
28 mg/5ml
125 mg
500 mg

Human Medicinal Products


S/No:

861.

862.

Registration Number

TZ11H168

TZ11H169

Registrant
863.

TAN 00,4458 P01B DAF

Product Name
Pack and Pack size

Ingredient(s) and Strength

865.

866.

B304

TAN 00,4416 P01B DAF

TAN 05,638 P01B DAF

Manufacturer

Ceftyl 500,Tablet

Cefuroxime Axetil Ph Eur

600 mg

24

Bilim Pharmaceutials A.S


TURKEY

Cefuroxime Axetil Ph Eur

300 mg

24

Bilim Pharmaceutials A.S


TURKEY

40 mg

36

Erfa nv
BELGIUM

B-artemether IH

20 mg/ml

36

Rotexmedica GMBH
GERMANY

Sulfamethopyrazine IH
Pyrimethamine USP

500 mg
25 mg

36

Erfa nv/sa
BELGIUM

100 mg
250 mg
12.5 mg

36

Erfa nv
BELGIUM

Ceftyl 250,Tablet

Dafra Pharma N.V - BELGIUM


Artesiane,Suppositories

Artemether Ph Eur

864.

Shelf life
month

Artesiane 20,Injectable
Solution

Dafrafin,Tablet

Co Arinate Juniour,Tablet

Artesunate IH
Sulfamethopyrazine IH
Pyrimethamine USP

Page 137 of 584

Human Medicinal Products


S/No:

867.

Registration Number

TAN 05,637 P01B DAF

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,746 J01D BIL

200 mg
500 mg
25 mg

36

Erfa nv
BELGIUM

500 mg/vial

36

Bilim Pharmaceuticals A.S,


TURKEY

Lumefantrine Ph Eur
Artemether IH

18 mg/ml
3 mg/ml

24

MPF BV
NETHERLANDS

Ketoconazole Ph Eur

20 mg/ml

36

Pannoc Chemie
BELGIUM

Ketoconazole Ph Eur

200 mg/ml

24

Pannoc Chemie
BELGIUM

100 mg/ml

24

Rotexmedica GMBH
GERMANY

Cetafor,Powder for Injection

Ceftriaxone Disodium
Trihydrate equivalent to
Ceftriaxone Ph Eur
869.

870.

871.

872.

TAN 06,395 P01B DAF

F150

TAN 07,296 J02A DAF

TAN 10, 008 P01B DAF

Co-Artesiane,Powder for
Reconstitution

Kenazol,Shampoo

Kenazol,Shampoo

Artesiane,Injectable Solution

Artemether BP

Registrant

Manufacturer

Co Arinate,Tablet

Artesunate IH
Sulfamethopyrazine IH
Pyrimethamine USP
868.

Shelf life
month

Denk Pharma GmbH & Co. KG - GERMANY

Page 138 of 584

Human Medicinal Products


S/No:

873.

Registration Number

TAN 09,127 C03C E.D

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 09,126 N02B E.D

TAN 09,125 N02B E.D

Para Co-Denk
1000/60,Suppositories

Paracetamol Ph Eur
Codeine Phosphate
Hemihydrate Ph Eur

876.

877.

878.

879.

TAN 00,4461 A10B E.D

TAN 05,479 J01K E.D

TAN 00,692 J05A E.D

TAN 00,696 A02A E.D

40 mg

60

Pharma GmbH & Co.KG


GERMANY

500 mg
30 mg

24

Bene Avzneimittel GmbH


GERMANY

1000 mg
60 mg

24

Bene Avzneimittel GmbH


GERMANY

Para Co-Denk 500/30,Tablet

Paracetamol Ph Eur
Codeine Phosphate
Hemihydrate Ph Eur
875.

Manufacturer

Furo - Denk 40,Tablet

Frusemide Ph Eur

874.

Shelf life
month

Metformin Denk,Tablet

Metformin Hydrochloride Ph 850 mg


Eur

60

Ciprofloxacin Hydrochloride 500 mg


BP

36

Denk Pharma GmbH & Co.


KG
GERMANY

Cipro Denk,Tablet
Pharma GmbH & Co.KG
GERMANY

Acyclovir Denk,Tablet

Acyclovir Ph Eur

200 mg

48

Ranitidine Hydrochloride
BP

150 mg

36

Denk Pharma GmbH & Co.


KG
GERMANY

Rani Denk,Tablet

Page 139 of 584

Denk Pharma GmbH & Co.


KG
GERMANY

Human Medicinal Products


S/No:

880.

Registration Number

TAN 06,043 V07A E.D

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 06,042 C01E E.D

TAN 09,041 N02B E.D

36

50 mg
25 mg

60

200 mg/5ml

36

Bene Avzneimittel GmbH


GERMANY

Beta Arthemether IP

40 mg

24

A.R.CO Chemie GmBH


GERMANY

Ranitidine Hydrochloride
BP

150 mg

36

Ferrous Fumarate IH

50 mg

48

Amlodipine mesilate IH

10 mg

24

Captopril+ HCT Denk


50/25,Tablet

884.

885.

886.

TAN 09,042 P01B E.D

TAN 00,696 A02A E.D

TAN 10,010 B03A E.D

TAN 10,009 C01K

Denk Pharma GmbH & Co.


KG
GERMANY

Para-Denk 4%,Syrup

Paracetamol BP/Ph.Eur

883.

Denk Pharma GmbH & Co.


KG
GERMANY

200 mg
250 mg

Captopril Ph Eur
Hydrochlorthiazide Ph Eur

882.

Manufacturer

Denkalgin,Tablet

Paracetamol BP
Acetylsalicylic Acid BP

881.

Shelf life
month

AmetherDenk,Capsules

Rani Denk,Tablet
Denk Pharma GmbH & Co.
KG
GERMANY

Ferro - Denk,Tablet
Lomapharm
GERMANY

Amlo-Denk,Tablet

Page 140 of 584

Denk Pharma GmbH & Co.


KG
GERMANY

Human Medicinal Products


S/No:

887.

Registration Number

TAN 10, 059 C01K

Product Name
Pack and Pack size

Ingredient(s) and Strength

TZ11H160

889.

TZ11H186

TZ11H031

TZ11H157

892.

TAN 00,4539 A10B DR.

24

353mg mg

36

0.5 g/vial

36
month
s

1.415mg mg

36
month
s

Denk Pharma GmbH & Co.


KG
GERMANY

ACS DOBFAR SPA-ACSD2


ITALY

Triaxone 0.5g,Injection
ACS DOBFAR SPA-ACSD2
ITALY

Triaxone 1.0g,Injection

Ceftriaxone Sodium USP

Registrant

5 mg

Denk Pharma GmbH & Co.


KG
GERMANY

Triaxone 0.25g,Injection

Cefuroxime Sodium USP

891.

36

Dr. Osman Sabir - TANZANIA


Ceftriaxone Sodium USP

890.

5 mg

Toras-Denk 5,Tablet

Torasemide Ph.Eur/USP

Registrant

Manufacturer

Amlo-Denk,Tablet

Amlodipine mesilate IH

888.

Shelf life
month

ACS DOBFAR SPA-ACSD2


ITALY

Dr. Reddy`s Laboratories Ltd. - INDIA


Diavista,Tablet

Pioglitazone Hydrocloride
equivalent Pioglitazone IH

Page 141 of 584

15 mg

24

Dr. Reddy`s Laboratories


Ltd.
INDIA

Human Medicinal Products


S/No:

893.

894.

895.

896.

897.

898.

899.

Registration Number

TAN 09,290 V03A PRI

TAN 00,550 J05A DR.

TAN 00,554 C01K DR.

TAN 00,556 D01B DR.

TAN 00,546 D01B DR.

TAN 00,670 A10B DR.

TAN 00,671 J03C DR.

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

stamlo beta,Tablet

Amlodipine Besylate BP
Atenolol BP

5 mg
50 mg

24

Acyclovir BP

200 mg

36

Amlodipine Besylate IH

10 mg

36

Fluconazole IH

150 mg

36

Terbinafine Hydrochloride
IH

250 mg

36

Gliclazide BP

80 mg

24

Sparfloxacin IH

200 mg

36

Dr. Reddy`s Laboratories


Ltd.
INDIA

Klovir,Tablet
Dr. Reddy`s Laboratories
Ltd.
INDIA

Stamlo,Tablet
Dr. Reddy`s Laboratories
Ltd.
INDIA

Zolstan,Tablet
Dr. Reddy`s Laboratories
Ltd.
INDIA

Exifine,Tablet
Dr. Reddy`s Laboratories
Ltd.
INDIA

Reclide,Tablet
Dr. Reddy`s Laboratories
Ltd.
INDIA

Sparflo,Tablet

Page 142 of 584

Dr. Reddy`s Laboratories


Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

Registrant
900.

901.

902.

903.

904.

TAN 00,068 C01E E.R

TAN 00,1050 C01E E.R

TAN 00,067 C01E E.R

TAN 00,064 H02A E.R

TAN 00,065 D07X E.R

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 00,066 D07X E.R

Manufacturer

E.R Squibb & Sons Ltd. - UNITED KINGDOM


Capozide,Tablet

Hydrochlorthiazide Ph Eur
Captopril USP

25 mg
50 mg

36

E.R Squibb & Sons Ltd.


UNITED KINGDOM

Captopril USP

25 mg

36

E.R Squibb & Sons Ltd.


UNITED KINGDOM

Captopril USP

50 mg

E.R Squibb & Sons Ltd.


UNITED KINGDOM

Gramicidin USP
Nystatin USP
Neomycin Sulphate USP
Triamcinolone USP

0.2 mg
20.83 mg
4.24 mg
1 mg

24

0.25 mg
100000 IU
1000 mg

48

E.R Squibb & Sons Ltd.


UNITED KINGDOM

36

E.R Squibb & Sons Ltd.


UNITED KINGDOM

Capoten,Tablet

Capoten,Tablet

Kenacomb,Cream
beiersdorf consummer
product (T) Ltd
SOUTH AFRICA

Kenacomb,Ointment

Gramicidin USP
Nystatin USP
Triamcinolone Acetonide
USP
Neomycin Sulphate USP
905.

Shelf life
month

2.5 mg

Kenalog in orabase,Ointment

Triamcinolone Acetonide
USP

Page 143 of 584

0.1 g/100g

Human Medicinal Products


S/No:

906.

Registration Number

TAN 00,064 H02A E.R

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 00,065 D07X E.R

TAN 00,066 D07X E.R

909.

910.

911.

TAN 00,1051 N02B ECP

TAN 00,1052 N02B ECP

TAN 00,4201 M01A EGY

24

0.25 mg
100000 IU
1000 mg

48

E.R Squibb & Sons Ltd.


UNITED KINGDOM

36

E.R Squibb & Sons Ltd.


UNITED KINGDOM

2.5 mg

Kenalog in orabase,Ointment

Triamcinolone Acetonide
USP

Registrant

beiersdorf consummer
product (T) Ltd
SOUTH AFRICA

0.2 mg
20.83 mg
4.24 mg
1 mg

Kenacomb,Ointment

Gramicidin USP
Nystatin USP
Triamcinolone Acetonide
USP
Neomycin Sulphate USP
908.

Manufacturer

Kenacomb,Cream

Gramicidin USP
Nystatin USP
Neomycin Sulphate USP
Triamcinolone USP
907.

Shelf life
month

0.1 g/100g

Egyptian Co. for Chemicals & Pharmaceuticals S.A.E - EGYPT


Amadol,Injectable Solution

Tramadol Hydrochloride IH 100 mg/2ml

36

Tramadol Hydrochloride IH 50 mg

36

Egyptian Co. for Chemicals


& Pharmaceuticals S.A.E
EGYPT

Amadol,Capsules
Egyptian Co. for Chemicals
& Pharmaceuticals S.A.E
EGYPT

Profenazone,Capsules

Ibuprofen BP
Chlorzoxazone USP

Page 144 of 584

200 mg
250 mg

36

Egyptian Co. for Chemicals


& Pharmaceuticals S.A.E
EGYPT

Human Medicinal Products


S/No:

912.

913.

Registration Number

TAN 05,021 N02B EGY

TAN 05,020 G02A EGY

Registrant
914.

TAN 00,701 J01C EIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

916.

917.

TAN 00,707 R05C EIP

TAN 00,1578 D07A EIP

TAN 00,1579 D07A EIP

Manufacturer

Amadol SR,Tablet

Tramadol Hydrochloride IH 100 mg

36

Misoprostol IH

24

Egyptian Co. for Chemicals


& Pharmaceuticals S.A.E
EGYPT

Vagiprost,Pessaries
25 mcg

Egyptian Co. for Chemicals


& Pharmaceuticals S.A.E
EGYPT

EIPICO - EGYPT
Flumox,Suspension

Flucloxacillin Sodium
125 mg/5ml
Monohydrate equivalent to
Flucloxacillin BP
Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP
915.

Shelf life
month

24

EIPICO
EGYPT

48

EIPICO
EGYPT

36

EIPICO
EGYPT

36

EIPICO
EGYPT

Bronchophane,Syrup

Dextromethorphan USP
Diphenydramine
Hydrochloride USP
Ephedrine Hydrochloride
USP
Guaiphenesin USP

125 mg/100ml
100 mg/100ml

Betamethasone BP

100 mg

150 mg/100ml
1 mg/100ml

Betaderm,Cream

Betaderm,Ointment

Betamethasone Valerate BP 0.1 %w/w

Page 145 of 584

Human Medicinal Products


S/No:

918.

Registration Number

TAN 00,2324 J01D EIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Epicephin,Powder for
Injection

920.

921.

922.

TAN 00,4359 P01A EGY

TAN 00,4358 P01A EGY

TAN 05,757 J02A EGY

TAN 07,177 A11E EIP

Registrant

Manufacturer

36

EIPICO
EGYPT

2 mg/100ml
Diloxanide Furoate BP
Metronidazole Benzoate BP 4 mg/100ml

36

EIPICO
EGYPT

250 mg
Diloxanide Furoate BP
Metronidazole Benzoate BP 200 mg

36

EIPICO
EGYPT

Fluconazole IH

150 mg

36

EIPICO
EGYPT

Thiamine Hydrochloride BP
Cyanocobalamine BP
Riboflavine BP
Nicotinamide BP
Calcium D Panthothenate
BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Folic Acid USP

50 mg
0.25 mg
15 mg
100 mg
50 mg

36

EIPICO
EGYPT

Ceftriaxone Disodium
Trihydrate equivalent to
Ceftriaxone USP

919.

Shelf life
month

1g

Furazole,Suspension

Furazole,Tablet

Treflucan,Capsules

Neurofol,Tablet

200 mg
0.5 mg

Eli Lilly & Company Ltd. - UNITED KINGDOM

Page 146 of 584

Human Medicinal Products


S/No:

923.

Registration Number

TAN 09,128 N06A ELI

Product Name
Pack and Pack size

Ingredient(s) and Strength

924.

TAN 07,298 N04A ELI

36

Patheon France
FRANCE

10 mg

36

Lilly S.A
SPAIN

100 IU/ml

24

Lilly Egypt S.A.E


EGYPT

100 IU/ml

24

Lilly Egypt S.A.E


EGYPT

100 IU/ml

24

Lilly Egypt S.A.E


EGYPT

100 IU/ml

24

Lilly France S.A.S


FRANCE

Eli Lilly (Suisse) S.A - KENYA


Zyprexa,Tablet

Olanzapine IH

925.

TAN 05,486 A10A ELI

Humulin 70/30,Suspension

Human Insulin
(Recombinant DNA origin)
Ph Eur
926.

TAN 05,482 A10A ELI

Humulin Regular,Injectable
Solution

Insulin Regular Ph Eur

927.

TAN 05,481 A10A ELI

Humulin Isophane,Injectable
Solution

Isophane Insulin Ph Eur

928.

TAN 05,483 A10A ELI

Manufacturer

Prozac,Tablet

Fluoxetine Hydrochloride IH 20 mg

Registrant

Shelf life
month

Humulin Regular,Injectable
Solution

Human Insulin
(Recombinant DNA origin)
Ph Eur

Page 147 of 584

Human Medicinal Products


S/No:

929.

930.

931.

932.

933.

Registration Number

TAN 05,759 G04B ELI

TAN 05,758 G04B ELI

TAN 06,140 G04B ELI

TAN 06,139 G04B ELI

TAN 07,299 N04A ELI

Registrant
934.

TAN 00,029 J01D ELI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Yentreve,Capsules

Duloxetine Hydrochloride
equivalent to Duloxetine IH

20 mg

24

Lilly S.A
SPAIN

Duloxetine Hydrochloride
equivalent to Duloxetine IH

40 mg

24

Lilly S.A
SPAIN

Duloxetine Hydrochloride
30 mg
equivalent to Duloxetine IHS

24

Lilly S.A
SPAIN

Duloxetine Hydrochloride
equivalent to Duloxetine IH

60 mg

24

Lilly S.A
SPAIN

Olanzapine IH

5 mg

36

Lilly S.A
SPAIN

500 mg

36

Eli Lilly Italia S.p.A


ITALY

Yentreve,Capsules

Cymbalta,Capsules

Cymbalta,Capsules

Zyprexa,Tablet

Eli Lilly Italia S.p.A - ITALY


Keflex,Capsules

Cephalexin Monohydrate
equivalent to Cephalexin
Anhydrous Ph Eur

Registrant

Shelf life
month

El-Nasr Pharmaceutical and Chemical Company - EGYPT

Page 148 of 584

Human Medicinal Products


S/No:

935.

936.

937.

938.

Registration Number

TAN 00,2546 A12C ELN

TAN 00,2548 B05B ELN

TAN 00,4278 B05B ELN

TAN 06,141 B05B ELN

Registrant
939.

TAN 05,488 C01E ELP

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 05,489 J01C ELP

Manufacturer

Sodium Chloride,Solution

Sodium Chloride BP

0.9 %w/v

60

Mannitol BP

10 %w/v

36

Sodium Chloride BP
Potassium Chloride BP
Dextrose Anhydrous BP
Sodium Acetate BP

1.46
0.55
9.99
2.72

24

Dextrose BP
Sodium Chloride BP

5g
0.9 g

El-Nasr Pharmaceutical and


Chemical Company
EGYPT

Mannitol,Solution
El-Nasr Pharmaceutical and
Chemical Company
EGYPT

Rehydration,Solution

Sodium Chloride +
Dextrose,Infusion

mg
g
g
g

54

El-Nasr Pharmaceutical and


Chemical Company
EGYPT

El-Nasr Pharmaceutical and


Chemical Company
EGYPT

Elpen Pharmaceutical Co.Inc - GREECE


Pertacilon,Tablet

Captopril Ph Eur

940.

Shelf life
month

25 mg

24

Elpen Pharmaceutical
Co.Inc
GREECE

Fugentin,Tablet
125 mg
Clavulanic Acid Ph Eur
Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin Ph
Eur

Page 149 of 584

24

Elpen Pharmaceutical
Co.Inc
GREECE

Human Medicinal Products


S/No:

941.

942.

943.

944.

945.

946.

947.

Registration Number

Product Name
Pack and Pack size

TAN 05,487 J01C ELP

Fugentin,Powder for
Suspension

TAN 06,044 C01D ELP

TAN 06,045 J01C ELP

TAN 06,046 J01D ELP

TAN 06,047 J01D ELP

TAN 06,048 C01K ELP

TAN 06,142 J01F ELP

Ingredient(s) and Strength

Shelf life
month

31.25 mg/5ml
Clavulanic Acid Ph Eur
Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin Ph
Eur

24

Diltiazem Hydrochloride
USP

36

Manufacturer

Elpen Pharmaceutical
Co.Inc
GREECE

Dipen,Tablet
60 mg

Fugentin,Powder for
Suspension

62.5 mg/5ml
Clavulanic Acid Ph Eur
Amoxicillin Trihydrate
250 mg/5ml
equivalent to Amoxicillin Ph
Eur

18

Cefatrizine Ph Eur

500 mg

36

Cefatrizine Ph Eur

250 mg/5ml

24

Nifedipine USP

20 mg

36

Clarithromycin USP

500 mg

36

Elpen Pharmaceutical
Co.Inc
GREECE

Elpen Pharmaceutical
Co.Inc
GREECE

Cetrizin,Capsules

Cetrizin,Powder for
Suspension

Elpen Pharmaceutical
Co.Inc
GREECE

Elpen Pharmaceutical
Co.Inc
GREECE

Macorel,Capsules
Elpen Pharmaceutical
Co.Inc
GREECE

Claripen,Tablet

Page 150 of 584

Elpen Pharmaceutical
Co.Inc
GREECE

Human Medicinal Products


S/No:

948.

Registration Number

TAN 06,396 J01F ELP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Claripen,Granules for
suspension

Clarithromycin USP

949.

TAN 06,399 C04A ELP

951.

952.

TAN 06,398 C04A ELP

TAN 06,397 C04A ELP

TAN 07,470 J01F ELP

953.

TAN 00,1397 M01A ELY

24

20 mg

60

Elpen Pharmaceutical
Co.Inc
GREECE

Elpen Pharmaceutical
Co.Inc
GREECE

Pensordil,Tablet

Isosorbide Dinitrate Ph Eur 5 mg

60

Isosorbide Dinitrate Ph Eur 10 mg

60

Elpen Pharmaceutical
Co.Inc
GREECE

Pensordil,Tablet

Claripen,Powder for
Suspension

Clarithromycin USP

Registrant

250 mg/5ml

Manufacturer

Monosordil,Capsules

Isosorbide Mononitrate Ph
Eur

950.

Shelf life
month

125 mg/5ml

36

Elpen Pharmaceutical
Co.Inc
GREECE

Elpen Pharmaceutical
Co.Inc
GREECE

Elys Chemical industries Ltd. - KENYA


Elymol,Suspension

Paracetamol BP

Page 151 of 584

120 mg/5ml

24

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

954.

Registration Number

TAN 00,4543 A11G ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

956.

957.

958.

959.

960.

TAN 00,4544 R06A ELY

TAN 00,4545 B03A ELY

TAN 00,4546 N04A ELY

TAN 00,2128 J01K ELY

TAN 00,2330 D07A ELY

TAN 00,2327 A12A ELY

Manufacturer

Ascorbic Acid,Tablet
100 mg

36

Promethazine BP

25 mg

36

Folic Acid BP

5 mg

48

Chlorpromazine
Hydrochloride BP

100 mg

36

Ciprofloxacin IH

500 mg

36

Hydrocortisone BP

1 %w/w

36

Ascorbic Acid BP

955.

Shelf life
month

Elys Chemical industries


Ltd.
KENYA

Promethazine,Tablet
Elys Chemical industries
Ltd.
KENYA

Folic Acid,Tablet
Elys Chemical industries
Ltd.
KENYA

Chlorpromazine,Tablet
Elys Chemical industries
Ltd.
KENYA

Ciflo,Tablet
Elys Chemical industries
Ltd.
KENYA

Elycort,Ointment

Feritone B,Syrup

Page 152 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Nicotinamide BP
Pyridoxine Hydrochloride
BP
Thiamine Hydrochloride BP
Ferric Ammonium Citrate
BP
Riboflavine BP
961.

TAN 00,2331 A11B ELY

5 mg/5ml
1 mg/5ml

963.

964.

965.

TAN 00,2334 N02B ELY

TAN 00,2332 P01A ELY

TAN 00,4462 J01A ELY

TAN 05,491 D04A ELY

24

Manufacturer
Elys Chemical industries
Ltd.
KENYA

2 mg/5ml
200 mg/5ml
0.5 mg/5ml

Elydac,Syrup
5 mg/5ml
Nicotinamide IH
Riboflavine Sodium
0.5 mg/5ml
Phosphate IH
Thiamine Hydrochloride IH 0.5 mg/5ml
20 mg/5ml
Ascorbic Acid IH
1500 IU/5ml
Vitamin A IH
250 mg/5ml
Cholecalciferol IH

962.

Shelf life
month

24

Elys Chemical industries


Ltd.
KENYA

Mefenamic Acid,Capsules

Mefanamic Acid BP

250 mg

36

Tinidazole BP

500 mg

36

Tetracycline Hydrochloride
BP

250 mg

36

0.3 g

36

Elys Chemical industries


Ltd.
KENYA

Tidazol,Tablet
Elys Chemical industries
Ltd.
KENYA

Elytetra,Capsules
Elys Chemical industries
Ltd.
KENYA

Mepyramine maleate,Cream

Mepyramine Maleate BP

Page 153 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

966.

967.

968.

969.

970.

971.

972.

Registration Number

TAN 05,490 J03A ELY

TAN 05,640 R02A ELY

TAN 05,760 N02B ELY

TAN 00,1392 J01C ELY

TAN 00,1394 D01A ELY

TAN 00,1395 D01A ELY

TAN 00,1396 P01B ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Sulfa,Ointment
36

Sulphur BP

10 %w/w

Folic Acid BP

5 mg

Caffeine BP
Paracetamol BP
Acetylsalicylic Acid BP

60 mg
250 mg
600 mg

48

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

36

Clotrimazole BP

100 mg

36

Nystatin BP

100000 IU

24

Pyrimethamine BP
Sulfadoxine BP

25 mg
500 mg

48

Elys Chemical industries


Ltd.
KENYA

Folic Acid,Tablet
Elys Chemical industries
Ltd.
KENYA

Homadex,Tablet
Elys Chemical industries
Ltd.
KENYA

Ampicillin,Capsules
Elys Chemical industries
Ltd.
KENYA

Candistat,Pessaries
Elys Chemical industries
Ltd.
KENYA

Fungistin,Pessaries
Elys Chemical industries
Ltd.
KENYA

Orodar,Tablet

Page 154 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

973.

Registration Number

TAN 00,1401 P02X ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 00,1402 P01B ELY

TAN 00,1403 P02X ELY

977.

978.

979.

TAN 00,1404 R03A ELY

TAN 00,1406 P01A ELY

TAN 06,485 P01B ELY

TAN 00,1977 M02A ELY

30

50 mg/5ml

24

100 mg/5ml

24

Elys Chemical industries


Ltd.
KENYA

Elys Chemical industries


Ltd.
KENYA

Wormol,Suspension

Mebendazole BP

976.

40 mg/5ml

Emoquin,Suspension

Amodiaquine USP

975.

Manufacturer

Vumtrex,Syrup

Levamisole BP

974.

Shelf life
month

Elys Chemical industries


Ltd.
KENYA

Ventosal,Syrup

Salbutamol Sulphate
2 mg/5ml
equivalent to Salbutamol BP

24

Metronidazole Benzoate BP 200 mg/5ml

24

Sulfadoxine BP
Pyrimethamine BP

24

Elys Chemical industries


Ltd.
KENYA

Elogyl,Suspension
Elys Chemical industries
Ltd.
KENYA

Orodar,Suspension

Nauma Pain Balm,Ointment

Page 155 of 584

250 mg/5ml
12.5 mg/5ml

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

980.

981.

982.

983.

Registration Number

TAN 06,049 M02A ELY

TAN 00,192 P02X ELY

TAN 00,1391J01C ELY

TAN 00,1393 D01A ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

Camphor oil BP
Eucalyptus Oil BP
Methyl Salicylate

5 %w/w
5 %w/w
10 %w/w

Methyl Salicylate BP
Turpentine Oil BP
Menthol BP
Clove Oil BP

2 %w/w
4.5 %w/w
1 %w/w

Camphor oil BP
Eucalyptus Oil BP
Turpentine Oil BP
Methyl Salicylate BP
Capsicum Oleoresin USP

0.4 %w/v
0.4 %w/v
40 %w/v
3 %w/v
0.6 %w/v

TAN 00,1408 J01H ELY

24

Manufacturer
Elys Chemical industries
Ltd.
KENYA

Nauma,Liniment
24

Elys Chemical industries


Ltd.
KENYA

Cloxacillin,Syrup

Cloxacillin Sodium
125 mg/5ml
equivalent to Cloxacillin BP

30

Ampicillin Trihydrate
equivalent to Ampicillin BP

125 mg/5ml

36

6 %w/w
3 %w/w

36

Elys Chemical industries


Ltd.
KENYA

Ampicillin,Powder
Elys Chemical industries
Ltd.
KENYA

Whitfield Ointment,Ointment

Benzoic Acid BP
Salicylic Acid BP

984.

Shelf life
month

Elyclox,Powder for
Suspension

Ampicillin Trihydrate
143.8 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
136.3 mg
equivalent to Cloxacillin BP
Page 156 of 584

30

Elys Chemical industries


Ltd.
KENYA

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

985.

986.

987.

988.

989.

Registration Number

TAN 00,2330 D07A ELY

TAN 00,2330 D07A ELY

TAN 00,2327 A12A ELY

TAN 00,2327 A12A ELY

TAN 00,2334 N02B ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

TAN 00,2334 N02B ELY

Manufacturer

Elycort,Ointment

Hydrocortisone BP

1 %w/w

36

Hydrocortisone BP

1 %w/w

36

Nicotinamide BP
Pyridoxine Hydrochloride
BP
Thiamine Hydrochloride BP
Ferric Ammonium Citrate
BP
Riboflavine BP

5 mg/5ml
1 mg/5ml

24

Nicotinamide BP
Pyridoxine Hydrochloride
BP
Thiamine Hydrochloride BP
Ferric Ammonium Citrate
BP
Riboflavine BP

5 mg/5ml
1 mg/5ml

Elys Chemical industries


Ltd.
KENYA

Elycort,Ointment
Elys Chemical industries
Ltd.
KENYA

Feritone B,Syrup
Elys Chemical industries
Ltd.
KENYA

2 mg/5ml
200 mg/5ml
0.5 mg/5ml

Feritone B,Syrup
24

Elys Chemical industries


Ltd.
KENYA

2 mg/5ml
200 mg/5ml
0.5 mg/5ml

Mefenamic Acid,Capsules

Mefanamic Acid BP

990.

Shelf life
month

250 mg

36

250 mg

36

Elys Chemical industries


Ltd.
KENYA

Mefenamic Acid,Capsules

Mefanamic Acid BP

Page 157 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

991.

992.

993.

994.

995.

996.

997.

Registration Number

TAN 00,1775 P01B ELY

TAN 00,1778 D07A ELY

TAN 00,1779 J01H ELY

TAN 00,1782 J01H ELY

TAN 00,1784 N02B ELY

TAN 00,1786 P01A ELY

TAN 00,1789 M01A ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Quinine Sulphate,Tablet

Quinine Sulphate BP

300 mg

36

Hydrocortisone BP

1 %w/w

36

Elys Chemical industries


Ltd.
KENYA

Elycort,Cream
Elys Chemical industries
Ltd.
KENYA

Cloxacillin,Capsules

Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

30

Phenoxymethyl Penicillin BP 250 mg

30

Paracetamol BP

500 mg

48

Metronidazole BP

200 mg

48

25 mg

36

Elys Chemical industries


Ltd.
KENYA

Elypen,Tablet
Elys Chemical industries
Ltd.
KENYA

Elymol,Tablet
Elys Chemical industries
Ltd.
KENYA

Elogyl,Tablet
Elys Chemical industries
Ltd.
KENYA

Indomethacin,Capsules

Indomethacin BP

Page 158 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

998.

999.

Registration Number

TAN 00,1791 M01A ELY

TAN 00,1792 M01A ELY

1,000 TAN 00,1971 A11E ELY

1,001 TAN 00,1390 J01C ELY

1,002 TAN 00,1776 D01B ELY

1,003 TAN 00,1584 J01F ELY

1,004 TAN 00,1398 J03B ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Ibufen,Tablet

Ibuprofen BP

200 mg

36

Acetylsalicylic Acid BP

300 mg

48

Elys Chemical industries


Ltd.
KENYA

Aspirin,Tablet
Elys Chemical industries
Ltd.
KENYA

Vitamin B Complex,Tablet

Thiamine Hydrochloride BP 1.1 mg


1.15 mg
Riboflavin BP
16.5 mg
Nicotinamide BP

30

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

36

Griseofulvin BP

24

Elys Chemical industries


Ltd.
KENYA

Elymox,Syrup
Elys Chemical industries
Ltd.
KENYA

Grisefulvin,Tablet
500 mg

Elys Chemical industries


Ltd.
KENYA

Elocin,Syrup

Erythromycin
125 mg/5ml
Ethylsuccinate equivalent to
Erythromycin BP

30

Sulfamethoxazole BP
Trimethoprim BP

24

Elys Chemical industries


Ltd.
KENYA

Alprim,Suspension

Page 159 of 584

200 mg/5ml
40 mg/5ml

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

1,005 TAN 00,1399 A07A ELY

1,006 TAN 00,1400 P02X ELY

1,007 TAN 00,1780 H02A ELY

1,008 TAN 00,1793 D07X ELY

1,009 TAN 00,1794 A03B ELY

1,010 TAN 00,1795 D01A ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Oral Rehydration Salt,Powder

Glucose Anhydrous BP
Sodium Chloride BP
Potassium Chloride BP
Sodium Citrate Dihydrate
BP

20 mg
3.5 mg
3.5 mg
2.9 mg

36

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

36

Prednisolone BP

5 mg

30

Clotrimazole BP
Beclomethasone
Dipropionate BP
Gentamicin BP

1 %w/w
0.025 %w/w

30

Hyoscine Butylbromide BP

10 mg

36

Miconazole Nitrate BP

1 %w/w

36

Elys Chemical industries


Ltd.
KENYA

Alprim,Tablet
Elys Chemical industries
Ltd.
KENYA

Prednisolone,Tablet
Elys Chemical industries
Ltd.
KENYA

Elyclob G,Cream
Elys Chemical industries
Ltd.
KENYA

0.2 %w/w

Bukol,Tablet
Elys Chemical industries
Ltd.
KENYA

Fungistat,Cream

Page 160 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

1,011 TAN 00,1796 D07A ELY

1,012 TAN 00,1797 C03C ELY

1,013 TAN 00,1798 J01F ELY

1,014 TAN 00,1972 J01C ELY

1,015 TAN 00,1800 R05A ELY

1,016 TAN 00,1801 D07A ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Elyvate,Ointment

Betamethasone Valerate BP 0.1 %w/w

36

Frusemide BP

24

Elys Chemical industries


Ltd.
KENYA

Frusemide,Tablet
40 mg

Elys Chemical industries


Ltd.
KENYA

Elocin,Tablet

Erythromycin Stearate eq to 250 mg


Erythromycin BP

24

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

36

Paracetamol BP
Chlorpheniramine Maleate
BP
Phenylephrine BP
Caffeine BP

36

Elys Chemical industries


Ltd.
KENYA

Elymox,Capsules
Elys Chemical industries
Ltd.
KENYA

Cold Flu,Capsules
400 mg
4 mg

Elys Chemical industries


Ltd.
KENYA

5 mg
30 mg

Elyvate,Cream

Betamethasone Valerate BP 0.1 %w/w

1,017 TAN 00,1973 P02X ELY

Shelf life
month

Vumtrex,Tablet

Page 161 of 584

36

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Levamisole Hydrochloride
BP

1,018 TAN 00,1975 R03A ELY

1,019 TAN 00,2329 A02A ELY

1,020 TAN 00,1790 A02A ELY

1,021 TAN 00,2129 P02X ELY

1,022 TAN 00,2131 A11B ELY

40 mg

Shelf life
month
24

Manufacturer
Elys Chemical industries
Ltd.
KENYA

Ventosal,Tablet

Salbutamol Sulphate
4 mg
equivalent to Salbutamol BP

48

Aluminium Hdroxide Gel


equivalent to Aluminium
Hydroxide BP
Magnesium Trisilicate BP

120 mg

24

Aluminium Hydroxide BP
Magnesium Trisilicate BP

120 mg
250 mg

48

Mebendazole BP

100 mg

48

7.5 mg
Nicotinamide IH
Thiamine Hydrochloride IH 1 mg
15 mg
Ascorbic Acid IH
2500 IU
Vitamin A IH
0.5 mg
Riboflavine IH
250 IU
Cholecalciferol IH

36

Elys Chemical industries


Ltd.
KENYA

Alugel,Suspension
Elys Chemical industries
Ltd.
KENYA

250 mg

Stomacid,Tablet
Elys Chemical industries
Ltd.
KENYA

Wormol,Tablet
Elys Chemical industries
Ltd.
KENYA

Multivitamin,Tablet

Page 162 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

1,023 TAN 00,2328 J01B ELY

1,024 TAN 00,4095 P01B ELY

1,025 TAN 00,1392 J01C ELY

Product Name
Pack and Pack size

Ingredient(s) and Strength

Chloramphenicol IH

250 mg

36

Pyrimethamine BP
Sulfamethopyrazine IH

25 mg
500 mg

24

250 mg

36

250 mg

36

1,028 TAN 00,1406 P01A ELY

Registrant

Elys Chemical industries


Ltd.
KENYA

Ekelfin,Tablet
Elys Chemical industries
Ltd.
KENYA

Ampicillin,Capsules
Elys Chemical industries
Ltd.
KENYA

Ampicillin,Capsules

Ampicillin Trihydrate
equivalent to Ampicillin BP

1,027 TAN 00,1406 P01A ELY

Manufacturer

Elycetin,Capsules

Ampicillin Trihydrate
equivalent to Ampicillin BP

1,026 TAN 00,1392 J01C ELY

Shelf life
month

Elys Chemical industries


Ltd.
KENYA

Elogyl,Suspension

Metronidazole Benzoate BP 200 mg/5ml

24

Metronidazole Benzoate BP 200 mg/5ml

24

Elys Chemical industries


Ltd.
KENYA

Elogyl,Suspension

Emcure Pharmaceuticals Ltd. - INDIA

Page 163 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

1,029 TAN 09,129 C01K EMC

1,030 TAN 09,133 J01F EMC

1,031 TAN 09,130 J05A EMC

1,032 TAN 09,131 J05A EMC

1,033 TAN 09,132 J05A EMC

1,034 TAN 00,1802 J01K EMC

1,035 TAN 00,1803 J01K EMC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Asomex-2.5,Tablet

Amlodipine Besylate IH

2.5 mg

24

Clarithromycin USP

500 mg

36

Atazanavir sulfate IH

200 mg

36

Atazanavir sulfate IH

150 mg

24

Atazanavir sulfate IH

200 mg

36

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin
USP

18

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin
USP

18

Emcure Pharmaceuticals
Ltd.
INDIA

Acem,Tablet
Emcure Pharmaceutical
Ltd.
INDIA

Atazor,Capsules
Emcure Pharmaceuticals
Ltd
INDIA

Atazor,Capsules
Emcure Pharmaceuticals
Ltd
INDIA

Atazor,Tablet
Emcure Pharmaceuticals
Ltd
INDIA

Augpen,Tablet
Emcure Pharmaceuticals
Ltd
INDIA

Augpen,Tablet

Page 164 of 584

Emcure Pharmaceutical
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,036 TAN 00,2335 R05C EMC

1,037 TAN 00,2555 B03A EMC

1,038 TAN 00,2550 J01D EMC

1,039 TAN 00,2551 J01D EMC

1,040 TAN 00,2557 J01D HAR

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,042 TAN 00,2560 B02A HAR

Manufacturer

Vifex,Syrup

Bromhexine Hydrochloride 2 mg/5ml


BP
50 mg/5ml
Guaiphenesin BP
Salbutamol Sulphate
1 mg/5ml
equivalent to Salbutamol BP

24

Iron (III) Hydroxide


Polymatose Complex BP

50 mg/5ml

36

Cefixime Trihydrate USP

200 mg

24

Cefixime Trihydrate USP

50 mg/5ml

24

1g

24

Diclofenac Sodium BP

100 mg

36

Etamsylate BP

500 mg

24

Emcure Pharmaceuticals
Ltd.
INDIA

Orofer,Syrup
Emcure Pharmaceuticals
Ltd.
INDIA

C Tax,Tablet
Natco Pharma Ltd.
INDIA

C Tax P,Syrup
Emcure Pharmaceuticals
Ltd.
INDIA

C Tri,Powder for Injection

Ceftriaxone USP

1,041 TAN 00,2554 M05A EMC

Shelf life
month

Emcure Pharmaceuticals
Ltd.
INDIA

Diclomove sr,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Sylate,Tablet

Page 165 of 584

Emcure Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,043 TAN 00,2559 A11J HAR

1,044 TAN 00,2558 J01K HAR

1,045 TAN 00,4096 B03A EMC

1,046 TAN 09,130 J05A EMC

1,047 TAN 00,4468 C01K EMC

1,048 TAN 00,4467 J05A EMC

1,049 TAN 00,4465 J05A EMC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Caloshell,Tablet

Cholecalciferol BP
Calcium Carbonate IH

250 IU
1250 mg

36

Norfloxacin USP

400 mg

36

Folic Acid BP
Iron (III) Hydroxide
Polymatose Complex IH

350 mg
100 mg

36

Atazanavir sulfate IH

200 mg

36

Losartan Potassium IH

50 mg

24

Zidovudine USP
Lamivudine IH

300 mg
150 mg

24

Nevirapine IH

200 mg

24

Emcure Pharmaceuticals
Ltd.
INDIA

Zeflox,Tablet
IQ Fenamex S.A. DE C.V
MEXICO

Orofer,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Atazor,Capsules
Emcure Pharmaceuticals
Ltd
INDIA

Nusar,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Lazid,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Nevir,Tablet

Page 166 of 584

Emcure Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,050 TAN 00,4466 J05A EMC

1,051 TAN 00,4501 J05A EMC

1,052 TAN 05,022 B04A EMC

1,053 TAN 00,4548 M01A EMC

1,054 TAN 05,106 B03A EMC

1,055 TAN 05,105 J05A EMC

1,056 TAN 05,104 J05A EMC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Lavir,Tablet

Lamivudine IH

150 mg

24

Zidovudine USP

100 mg

24

Atorvastatin Calcium eq to
Atorvastatin IH
Atorvastatin Calcium
equivalent to Atorvastatin
IH

10 mg

24

Emcure Pharmaceuticals
Ltd.
INDIA

Zidine,Capsules
Emcure Pharmaceuticals
Ltd.
INDIA

Atorec,Tablet

10 mg

Emcure Pharmaceuticals
Ltd.
INDIA

Diclomove NDS,Cream

Diclofenac Sodium BP

1 %w/w

24

Iron (III) Hydroxide


Polymatose Complex IH

50 mg/ml

36

Zidovudine USP

50 mg/5ml

24

Nevirapine IH

50 mg/5ml

24

Emcure Pharmaceuticals
Ltd.
INDIA

Orofer,Solution
Emcure Pharmaceuticals
Ltd.
INDIA

Zidine,Solution
Emcure Pharmaceutical
Ltd.
INDIA

Nevir,Suspension

Page 167 of 584

Emcure Pharmaceutical
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,057 TAN 05,103 J05A EMC

1,058 TAN 05,173 C01K EMC

1,059 TAN 05,641 C01K EMC

1,060 TAN 07,035 J05A EMC

1,061 TAN 07,036 J05A EMC

1,062 TAN 00,2132 B03A EMC

1,063 TAN 00,2132 B03A EMC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Efcure,Tablet

Efavirenz IH

600 mg

24

Amlodipine Besylate IH

2.5 mg

24

Amlodipine Besylate IH

5 mg

24

Didanosine IH

100 mg

24

Lamivudine IH

50 mg/5ml

24

Folic Acid BP
Iron (Ferrous Sulphate) IH
Iron (III) Hydroxide
Polymatose Complex IH

550 mcg
100 mg
100 mg

24

Folic Acid BP
Iron (Ferrous Sulphate) IH
Iron (III) Hydroxide
Polymatose Complex IH

550 mcg
100 mg
100 mg

24

Emcure Pharmaceutical
Ltd.
INDIA

Asomex-2.5,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Asomex-5,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Dinor,Tablet
Emcure Pharmaceutical
Ltd.
INDIA

Lavir,Solution
Emcure Pharmaceutical
Ltd.
INDIA

Orofer,Capsules
Emcure Pharmaceuticals
Ltd.
INDIA

Orofer,Capsules

Page 168 of 584

Emcure Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,064 TAN 00,2554 M05A EMC

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,066 TAN 00,2560 B02A HAR

1,067 TAN 00,2560 B02A HAR

1,068 TAN 00,2559 A11J HAR

1,069 TAN 00,2559 A11J HAR

1,070 TAN 05,103 J05A EMC

Manufacturer

Diclomove sr,Tablet
100 mg

36

Diclofenac Sodium BP

100 mg

36

Etamsylate BP

500 mg

24

Etamsylate BP

500 mg

24

Cholecalciferol BP
Calcium Carbonate IH

250 IU
1250 mg

36

Cholecalciferol BP
Calcium Carbonate IH

250 IU
1250 mg

36

Efavirenz IH

600

24

Diclofenac Sodium BP

1,065 TAN 00,2554 M05A EMC

Shelf life
month

Emcure Pharmaceuticals
Ltd.
INDIA

Diclomove sr,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Sylate,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Sylate,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Caloshell,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Caloshell,Tablet
Emcure Pharmaceuticals
Ltd.
INDIA

Efcure,Tablet

Page 169 of 584

Emcure Pharmaceutical
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,071 TZ10H122

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,075 TAN 07,300 D07A ESA

1,076 TAN 05,080 R06A SCH

Emcure Pharmaceuticals
Ltd.
INDIA

24

Emcure Pharmaceuticals
Ltd.
INDIA

24

Emcure Pharmaceuticals
Ltd.
INDIA

Esapharm Srl. - ITALY


Movate,Cream

Clobetasol Propionate Ph
Eur

Registrant

24

Vintor,Injectable Solution

Recombinant human
2000 IU/ml
erythropoietin concentrated
solution IH

Registrant

Emcure Pharmaceuticals
Ltd.
INDIA

Lomoh,Injectable Solution

Enoxaparin Sodium Ph Eur 60 mg/0.6ml

1,074 TZ11H184

24

Lomoh,Injectable Solution

Enoxaparin Sodium Ph Eur 60 mg/0.6ml

1,073 TZ11H165

Manufacturer

Encifer,Injectable Solution

Ferric hydroxide in complex 100 mg/5ml


with sucrose IH

1,072 TZ11H164

Shelf life
month

0.05 %w/w

24

Esapharm Srl.
ITALY

Essex Chemie AG Scientific Office - Egypt, - EGYPT


Aerius,Syrup

Desloratadine USP/NF

Page 170 of 584

0.5 mg/ml

24

Schering Plough
Laboratories N.V
BELGIUM

Human Medicinal Products


S/No:

Registration Number

1,077 TAN 05,080 R06A SCH

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,078 TAN 09,012 J05B FLR

1,079 TAN 00,4549 V07A FLR

1,080 TAN 00,4550 V07A FLR

1,081 TAN 00,2135 J05A FLR

1,082 TAN 00,2137 N04B FLR

5 mg/ml

24

Schering Plough
Laboratories N.V
BELGIUM

F. Hoffman La Roche - SWITZERLAND


Neupogen,Injectable Solution

Filgrastim IH

Registrant

Manufacturer

Aerius,Tablet

Desloratadine USP/NF

Registrant

Shelf life
month

30 MU

24

F.Hoffman-La Roche Ltd


SWITZERLAND

F.Hoffman-La Roche Ltd - SWITZERLAND


Pegasys,Injection

Peginterferon Alfa-2a Ph
Eur

135 mcg/0.5ml

24

F.Hoffman-La Roche Ltd


SWITZERLAND

Peginterferon Alfa-2a Ph
Eur

180 mcg/0.5ml

24

F.Hoffman-La Roche Ltd


SWITZERLAND

Saquinavir Mesylate IH

200 mg

36

F.Hoffman-La Roche Ltd


SWITZERLAND

5 mg/5ml

36

F.Hoffman-La Roche Ltd


SWITZERLAND

Pegasys,Injection

Invirase,Capsules

Dormicum,Injectable Solution

Midazolam Ph Eur

Page 171 of 584

Human Medicinal Products


S/No:

Registration Number

1,083 TAN 00,2133 J01D FLR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Rocephin IM,Powder for


Injection

F.Hoffman-La Roche Ltd


SWITZERLAND

36

F.Hoffman-La Roche Ltd


SWITZERLAND

36

F.Hoffman-La Roche Ltd


SWITZERLAND

24

F.Hoffman-La Roche Ltd


SWITZERLAND

36

F.Hoffman-La Roche Ltd


SWITZERLAND

Ceftriaxone Sodium Ph Eur 1 g

24

F.Hoffman-La Roche Ltd


SWITZERLAND

Carvedilol IH

36

Roche Diagnostics GmbH


GERMANY

Rocephin IM,Powder for


Injection

Ceftriaxone Sodium Ph Eur 500 mg/vial

1,085 TAN 00,2136 J01D FLR

Rocephin IM,Powder for


Injection

Ceftriaxone Sodium Ph Eur 250 mg

1,086 TAN 00,2139 J01D FLR

Rocephin IV,Powder for


Injection

Ceftriaxone Sodium Ph Eur 250 mg

1,087 TAN 00,2138 J01D FLR

Rocephin IV,Powder for


Injection

Ceftriaxone Sodium Ph Eur 500 mg

1,088 TAN 00,2140 J01D FLR

1,089 TAN 05,024 C06A FLR

Manufacturer

36

Ceftriaxone Sodium Ph Eur 1 g

1,084 TAN 00,2134 J01D FLR

Shelf life
month

Rocephin IV,Powder for


Injection

Dilatrend,Tablet

Page 172 of 584

12.5 mg

Human Medicinal Products


S/No:

Registration Number

1,090 TAN 00,1055 J05A FLR

1,091 TAN 05,761 L01D FLR

1,092 TAN 06,052 A08A FLR

1,093 TAN 00,2140 J01D FLR

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,095 TAN 07,302 C06A F.H

1,096 TAN 07,303 J05A F.H

Manufacturer

Viracept,Tablet

Nelfinavir Mesylate
equivalent to Nelfinavir IH

15 mg

36

Roche Farma SA
SPAIN

Mycophenolate Mefetil IH

500 mg

36

Syntex Puerto Rico Inc.


PUERTO RICO

Orlistat IH

120 mg

36

F.Hoffman-La Roche Ltd


SWITZERLAND

24

F.Hoffman-La Roche Ltd


SWITZERLAND

Ceftriaxone Sodium Ph Eur 1 g

24

F.Hoffman-La Roche Ltd


SWITZERLAND

Carvedilol IH

25 mg

24

Roche S.p.A. Milan


ITALY

Saquinavir Mesylate IH

500 mg

24

F.Hoffman-La Roche Ltd


SWITZERLAND

Cellcept,Tablet

Xenical,Capsules

Rocephin IV,Powder for


Injection

Ceftriaxone Sodium Ph Eur 1 g

1,094 TAN 00,2140 J01D FLR

Shelf life
month

Rocephin IV,Powder for


Injection

Dilatrend,Tablet

Invirase,Tablet

Page 173 of 584

Human Medicinal Products


S/No:

Registration Number

1,097 TAN 07,301 V03A FLR

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,100 TAN 09,015 P01B F.H

1,101 TAN 05,492 A10B FLR

25 mg
500 mg

36

F.Hoffman-La Roche Ltd


SWITZERLAND

100 mg/4ml

24

Genentech Inc.
USA

60

Roche Products(Pty) Ltd


SOUTH AFRICA

5 mg

48

Roche Diagnostics GmbH


GERMANY

1 mg/ml

36

F.Hoffmann-La-Roche Ltd
SWITZERLAND

Fansidar,Tablet
25 mg
500 mg

F.Hoffmann-La-Roche Ltd - SWITZERLAND


Euglucon,Tablet

Glibenclamide Ph Eur

1,102 TAN 06,279 A04A F.H

F.Hoffman-La Roche Ltd


SWITZERLAND

F.Hoffmann-la Roche (Pty) Ltd - SOUTH AFRICA


Pyrimethamine Ph Eur
Sulfadoxine Ph Eur

Registrant

24

Avastin,Injectable Solution

Bevacizumab IH

Registrant

150 mg

Fansidar,Injectable Solution

Pyrimethamine Ph Eur
Sulfadoxine Ph Eur

1,099 TAN 09,014 V03A FLR

Manufacturer

Bonviva,Tablet

Ibandronic acid IH

1,098 TAN 00,1056 P01B FLR

Shelf life
month

KYTRIL,Injectable Solution

Granisetron IH

Page 174 of 584

Human Medicinal Products


S/No:

Registration Number

1,103 TAN 06,280 L01B F.H

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,105 TAN 06,283 A04A F.H

1,106 TAN 08,006 N04B F.H

500 mg

48

F.Hoffmann-La-Roche Ltd
SWITZERLAND

Granisetron Eur/USP

3 mg/3ml

36

F.Hoffmann-La-Roche Ltd
SWITZERLAND

Granisetron IH

1 mg

48

F.Hoffmann-La-Roche Ltd
SWITZERLAND

50 mg/10ml

60

F.Hoffmann-La-Roche Ltd
SWITZERLAND

15 mg/3ml

60

F.Hoffmann-La-Roche Ltd
SWITZERLAND

Oseltamivir Phosphate
75 mg
equivalent to Oseltamivir IH

60

F.Hoffman-La Roche Ltd


SWITZERLAND

Capecitabine Ph Eur

24

F.Hoffmann-La-Roche Ltd
SWITZERLAND

KYTRIL,Injectable Solution

KYTRIL,Tablet

Dormicum,Injectable Solution

Midazolam IH

1,107 TAN 08,007 N04B F.H

Dormicum,Injectable Solution

Midazolam IH

1,108 TAN 09,016 J05A F.H

1,109 TAN 09,013 L01B FLR

Manufacturer

Xeloda,Tablet

Capecitabine IH

1,104 TAN 06,281 A04A F.H

Shelf life
month

Tamiflu,Capsules

Xeloda,Tablet

Page 175 of 584

150 mg

Human Medicinal Products


S/No:

Registration Number

Registrant
1,110 TAN 08,117 G03A FAM

1,111 TAN 05,762 G03A FAM

1,112 TAN 05,763 G03A FAM

1,113 TAN 06,284 G03A FAM

1,114 TZ10H104

Registrant
1,115 TAN 06,144 J01H FAR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Famy Care Ltd - INDIA


Depo Progestin,Injection

Medroxyprogesterone
Acetate USP

150 mg/ml

36

PT Harsen Laboratories
INDONESIA

Ferrous Fumarate BP
Levonorgestrel BP
Ethinylestradiol BP

75 mg
0.15 mg
0.0306 mg

36

Famy Care Ltd


INDIA

Levonorgestrel BP

0.03 mg

24

Famy Care Ltd


INDIA

Ferrous Fumarate USP


Ethinylestradiol USP
Norgestrel USP

75 mg
0.0306 mg
0.3 mg

24

Famy Care Ltd


INDIA

Levonorgestrel BP

0.75 mg

24

Famy Care Ltd


INDIA

250 mg

36

Farabi Pharmaceuticals
IRAN

Oralcon-F,Tablet

Hyan,Tablet

Lusia-F,Tablet

P2,Tablets

Farabi Pharmaceuticals - IRAN


Faramox 250,Capsules

Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

Page 176 of 584

Human Medicinal Products


S/No:

Registration Number

1,116 TAN 06,145 J01H FAR

Product Name
Pack and Pack size

Ingredient(s) and Strength

125 mg/5ml

24

Farabi Pharmaceuticals
IRAN

500 mg

36

Farabi Pharmaceuticals
IRAN

50 mg
Artesunate IH
Amodiaquine Hydrochloride 200 mg
equivalent to Amodiaquine
BP

24

Farma Italia SPA


ITALY

Faramox 500,Capsules

Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

Registrant
1,118 TAN 07,297 P01B DAF

Registrant
1,119 TAN 00,1808 A07C FDC

1,120 TAN 00,1805 S01D FDC

1,121 TAN 00,1808 A07C FDC

Manufacturer

Faramox 125,Dry Powder

Amoxicillin Trihydrate
equivalent to Amoxicillin
USP
1,117 TAN 06,143 J01H FAR

Shelf life
month

Farma Italia SPA - ITALY


Amonate FDC,Tablet

FDC Ltd. - INDIA


Electral Forte,Granules

Sodium Chloride BP
Sodium Citrate BP
Potassium Chloride BP

3.5 g/30g
2.9 g/30g
1.5 g/30g

24

FDC Ltd.
INDIA

Norfloxacin USP

0.3 %w/v

24

FDC Ltd.
INDIA

3.5 g/30g
2.9 g/30g
1.5 g/30g

24

FDC Ltd.
INDIA

Norzen,Solution

Electral Forte,Granules

Sodium Chloride BP
Sodium Citrate BP
Potassium Chloride BP

Page 177 of 584

Human Medicinal Products


S/No:

Registration Number

1,122 TAN 00,1416 D01B FDC

1,123 TAN 00,2141 D01B FDC

1,124 TAN 05,107 J03B FDC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Fluconazole USP

150 mg

36

FDC Ltd.
INDIA

Fluconazole USP

200 mg

24

FDC Ltd.
INDIA

400 mg
80 mg

36

FDC Ltd.
INDIA

125 mg/5ml

24

FDC Ltd.
INDIA

2 %w/w

24

FDC Ltd.
INDIA

0.7 %w/v

24

FDC Ltd.
INDIA

Ciprofloxacin Hydrochloride 0.3 %w/v


USP

24

FDC Ltd.
INDIA

Zocon,Tablet

Co-trimoxazole,Tablet

Salmadol,Suspension

Paracetamol BP

1,126 TAN 00,1804 J01K FDC

Allercrom,Ophthalmic
Solution

Cromolyn Sodium USP

1,127 TAN 00,1806 S01D FDC

Moisol,Ophthalmic Solution

Hydroxy Propyl Methyl


Cellulose USP

1,128 TAN 00,1807 S01D FDC

Manufacturer

Zocon,Tablet

Sulfamethoxazole BP
Trimethoprim BP

1,125 TAN 05,176 N02B FDC

Shelf life
month

Zoxan,Solution

Page 178 of 584

Human Medicinal Products


S/No:

Registration Number

1,129 TAN 00,4100 J01K FDC

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,130 TAN 09,136 J02A FOU

1,133 TAN 05,765 M01A FOU

1,134 TAN 05,764 A02A FOU

FDC Ltd.
INDIA

Fungistop,Tablet
150 mg

36

5 mg
500 mg

36

Natures Grace medicine


SDN BHD
MALAYSIA

Glifil M Forte,Tablet

Glibenclamide BP
Metformin BP

1,132 TAN 00,4340 D04A FOU

36

Fourrts(India) Laboratories Pvt. Ltd. - INDIA


Fluconazole USP

1,131 TAN 09,135 A10B FOU

Manufacturer

Zoxan,Tablet

Ciprofloxacin Hydrochloride 500 mg


IP

Registrant

Shelf life
month

Natures Grace medicine


SDN BHD
MALAYSIA

Profil,Tablet

Promethazine Hydrochloride 25 mg
BP

36

Diclofenac Sodium BP

36

Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Diclofen,Tablet
50 mg

Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Tumbosin,Tablet

Dried Aluminium Hydroxide 120 mg


BP
Magnesium Trisilicate BP 250 mg

Page 179 of 584

36

Natures Grace medicine


SDN BHD
MALAYSIA

Human Medicinal Products


S/No:

Registration Number

1,135 TAN 06,054 P01A FOU

1,136 TAN 06,053 N02B FOU

1,137 TAN 07,038 M01A FOU

1,138 TAN 07,039 J01A FOU

1,139 TAN 05,887 A02B FOU

1,140 TAN 08,098 P02X FOU

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Fogyl,Suspension

Metronidazole BP

200 mg/5ml

36

Paracetamol BP

120 mg/5ml

24

Piroxicam USP

20 mg

36

Doxycycline Hyclate BP

100 mg

36

Omeprazole IH

20 mg

18

400 mg/10ml

36

5 mg
500 mg

36

Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Parafil 120,Syrup
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Felcine,Capsules
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Doxefil,Capsules
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Omfil,Capsules
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Finazol 400 S,Suspension

Albendazole USP

1,141 TAN 09,135 A10B FOU

Shelf life
month

Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Glifil M Forte,Tablet

Glibenclamide BP
Metformin BP

Page 180 of 584

Natures Grace medicine


SDN BHD
MALAYSIA

Human Medicinal Products


S/No:

Registration Number

1,142 TAN 00,4398 N02B FOU

1,143 TAN 00,4344 D01B FOU

1,144 TAN 00,4344 D01B FOU

1,145 TAN 00,4341 J01F FOU

1,146 TAN 00,4341 J01F FOU

1,147 TAN 00,4398 N02B FOU

1,148 TAN 10, 062

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Parafil,Tablet

Paracetamol BP

500 mg

36

Griseofulvin BP

500 mg

36

Griseofulvin BP

500 mg

36

Erythromycin Stearate
equivalent to Erythromycin
BP

250 mg

36

Erythromycin Stearate
equivalent to Erythromycin
BP

250 mg

36

Paracetamol BP

500 mg

36

Natures Grace medicine


SDN BHD
MALAYSIA

Griseofil,Tablet
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Griseofil,Tablet
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Erythrofil,Tablet
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Erythrofil,Tablet
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Parafil,Tablet

Redin PN,Syrup

Page 181 of 584

Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Folic Acid BP
Manganese Sulphate BP
Zinc Sulphate BP
Copper Sulfate
Pentahydrate BP
Cyanocobalamin (Vitamin
B12) BP
Calcium Lactate
Pentahydrate BP
Protein Hydrolysate IH
Ferric Ammonium Citrate IH
Sodium Selenite IH
1,149 TZ10H086

1,151 TZ10H105

1,152 TAN 00,4344 D01B FOU

1,153 TAN 00,4341 J01F FOU

24

Manufacturer
Natures Grace medicine
SDN BHD
MALAYSIA

7.7 mg/10ml
51 mg/10ml
105 mg/10ml
237 mg/10ml
0.055 mg/10ml

Sucrafil O Gel,Suspension

Oxetacaine BP
Sucralfate USP

1,150 TZ10H103

1 mg/10ml
0.25 mg/10ml
35 mg/10ml
0.025 mg/10ml

Shelf life
month

20 mg/10ml
1 mg/10ml

36

Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Quadrajel,Gel

Metronidazole Benzoate BP 1 %w/w


Chlorhexidine Gluconate BP 1 %w/w
Lidocaine Hydrochloride BP 2 %w/w

24

Clotrimazole USP

2 %w/w

36

Griseofulvin BP

500 mg

36

Erythromycin Stearate
equivalent to Erythromycin
BP

250 mg

36

Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Fungifen,Cream
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Griseofil,Tablet
Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Erythrofil,Tablet

Page 182 of 584

Fourrts(India) Laboratories
Pvt. Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

Registrant
1,154 TAN 00,951 A07A FRS

1,155 TAN 00,952 A07C FRS

1,156 TAN 00,953 A01A FRS

1,157 TAN 05,108 B05B FRS

1,158 TAN 09,280 B05B FRS

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,159 TAN 00,1064 B05B FRS

Manufacturer

Fresenius Kabi India Ltd. - INDIA


Sodium Chloride +
Glucose,Solution

5 %w/v
0.9 %w/v

36

Fresenius Kabi India Ltd.


INDIA

Sodium Chloride BP

0.9 %w/v

36

Fresenius Kabi India Ltd.


INDIA

Calcium Chloride BP
Sodium Chloride BP
Sodium Lactate BP
Potassium Chloride BP

0.02 g/100ml
0.6 g/100ml
0.32 g/100ml
0.04 g/100ml

36

Fresenius Kabi India Ltd.


INDIA

Glucose Anhydrous BP

10 g/100ml

36

0.9 %w/v

36

Glucose Anhydrous BP
Sodium Chloride BP

Sodium Chloride,Solution

Compound Sodium
Lactate,Solution

Glucose,Solution
Fresenius Kabi India Pvt
Ltd
INDIA

Sodium Chloride,Infusion

Sodium Chloride BP

Registrant

Shelf life
month

Fresenius Kabi India Ltd.


INDIA

Fresenius Kabi India Pvt Ltd - INDIA


Sodium Chloride,Solution

Sodium Chloride BP

Page 183 of 584

0.9 %w/v

36

Fresenius Kabi India Pvt


Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

1,160 TAN 00,1065 B05B FRS

Registrant
1,161 TAN 00,1063 B05B FRS

Product Name
Pack and Pack size
Compound Sodium
Lactate,Solution

Ingredient(s) and Strength

Calcium Chloride BP
Sodium Chloride BP
Sodium Lactate BP
Potasium Iodide BP

1,164 TAN 05,766 B05B FRS

Registrant
1,165 TAN 06,287 N01A FRE

Fresenius Kabi India Pvt


Ltd
INDIA

Glucose,Solution
5 %w/v

36

0.5 %w/v

36

Ciprofloxacin Lactate USP

0.2 %w/v

24

Sodium Chloride BP
Potassium Chloride BP
Sodium Lactate IH

200 mg
130 mg
300 mg

36

Fresenius Kabi India Ltd.


INDIA

Metronidazole,Solution

Metronidazole USP

1,163 TAN 00,2147 J01K FRS

36

Manufacturer

Fresenius Kabi India Pvt. Ltd - INDIA


Glucose Anhydrous BP

1,162 TAN 00,2148 J01K FRS

0.27 g/100ml
0.4 g/100ml
3.2 g/100ml
6 g/100ml

Shelf life
month

Fresenius Kabi India Pvt.


Ltd
INDIA

Ciprofloxacin,Solution
Fresenius Kabi India Pvt.
Ltd
INDIA

Darrows,Solution
Fresenius Kabi India Pvt
Ltd
INDIA

Fresenius Kabi SA (Pty) Ltd - SOUTH AFRICA


Propofol,Injectable Solution

Propofol IH

Page 184 of 584

10 mg/ml

36

Fresenius Kabi SA (Pty) Ltd


SOUTH AFRICA

Human Medicinal Products


S/No:

Registration Number

1,166 TAN 06,286 N01A FRE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Thiopentone
Sodium,Injectable Solution

Thiopentone Sodium Ph Eur 0.5 mg/20ml

Registrant
1,167 TZ11H026

1,169 TAN 05,496 J01D GEN

36

150 mg

36

Galentic Pharma (India) PVT


Ltd
INDIA

Galentic Pharma (India) PVT


Ltd
INDIA

Generics International (SA) Pty Ltd. - SOUTH AFRICA


Rociject,Powder for Injection

Pen & Strep,Powder for


Injection

Benzathine Penicillin
Sodium BP

1,171 TAN 05,494 J01H GEN

10 mg

Caladin Lotion,Lotion

Ceftriaxone Sodium BP

1,170 TAN 05,493 J01H GEN

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Netracort Skin Cream,Cream

Calamine Lotion BP

Registrant

48

Manufacturer

Galentic Pharma (India) PVT Ltd - INDIA


Hydrocortisone Acetate BP

1,168 TZ11H027

Shelf life
month

1g

24

600 mg

24

500 mg

24

Harbin Pharmaceutical
Group Co.Ltd.
CHINA

Harbin Pharmaceutical
Group Co.Ltd.
CHINA

Ampiject,Powder for Injection

Ampicillin Sodium
equivalent to Ampicillin BP

Page 185 of 584

Harbin Pharmaceutical
Group Co.Ltd.
CHINA

Human Medicinal Products


S/No:

Registration Number

1,172 TAN 05,495 J01H GEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,173 TAN 00,4551 D07A GAL

24

15 mg

36

100000 IU

24

Gland Pharma Ltd


INDIA

10mg mg

24

Gland Pharma Ltd


INDIA

Betamethasone Valerate BP 0.5 mg


Lidocaine Hydrochloride BP 25 mg
Phenylephrine
1 mg
Hydrochloride BP

36

Gland Pharma Ltd


INDIA

Miconazole Nitrate BP

24

Gland Pharma Ltd


INDIA

Gland Pharma Ltd - INDIA


Netracort,Ointment

Netracycline,Ophthalmic
Ointment

Oxytetracycline
Hydrochloride BP

1,176 TAN 00,4279 D07X GAL

1,177 TAN 00,2451 D01A GAL

Galentic Pharma (India) PVT


Ltd
INDIA

Candistatin,Ointment

Nystatin USP

1,175 TAN 00,2338 S01A GAL

Harbin Pharmaceutical
Group Co.Ltd.
CHINA

1000 mg

Hydrocortisone Acetate BP

1,174 TAN 07,178 D01A GAL

Manufacturer

Ampiject,Powder for Injection

Ampicillin Sodium
equivalent to Ampicillin BP

Registrant

Shelf life
month

Pyloocain,Ointment

Fungigen,Cream

Page 186 of 584

2 %w/w

Human Medicinal Products


S/No:

Registration Number

1,178 TAN 00,2450 D01A GAL

1,179 TAN 00,4106 S01D GAL

1,180 TAN 00,4280 J01B GAL

1,181 TAN 00,4597 D01A GAL

1,182 TAN 05,109 J03C GAL

1,183 TAN 05,767 D07A GAL

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Candigen,Cream

Clotrimazole USP

1 %w/w

24

Acyclovir BP

3 mg/g

36

Chloramphenicol BP

10 mg/g

36

Benzoic Acid BP
Salicylic Acid BP

60 mg
30 mg

36

Silver Sulphadiazine USP

1 %w/w

36

Gland Pharma Ltd


INDIA

Netravir,Ointment
Galentic Pharma (India) PVT
Ltd
INDIA

Kloraxin,Ointment
Galentic Pharma (India) PVT
Ltd
INDIA

Whitefield,Ointment
Galentic Pharma (India) PVT
Ltd
INDIA

Silvadex,Cream
Galentic Pharma (India) PVT
Ltd
INDIA

Netracort,Ointment

Hydrocortisone Acetate USP 10 mg

1,184 TAN 05,769 D07A GAL

Shelf life
month

36

Galentic Pharma (India) PVT


Ltd
INDIA

Betamethasone,Cream

Betamethasone Valerate
USP

Page 187 of 584

0.1 %

36

Gland Pharma Ltd


INDIA

Human Medicinal Products


S/No:

Registration Number

1,185 TAN 05,768 M01A GAL

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Rubigel,Gel

Diclofenac Sodium BP
Linseed Oil IH
Menthol USP
Methyl Salicylate

10 mg
30 mg
50 mg
100 mg

24

Gland Pharma Ltd


INDIA

10mg mg

24

Gland Pharma Ltd


INDIA

24

GlaxoSmithkline (K) Ltd.


KENYA

36

GlaxoSmithkline (K) Ltd.


KENYA

24

GlaxoSmithKline Egypt
EGYPT

Methyl Salicylate USP/NF


1,186 TAN 00,2338 S01A GAL

Netracycline,Ophthalmic
Ointment

Oxytetracycline
Hydrochloride BP

Registrant
1,187 TAN 00,321 R03A GLA

GlaxoSmithkline (K) Ltd. - KENYA


Ventolin,Syrup

Salbutamol Sulphate
2 mg/5ml
equivalent to Salbutamol BP

1,188 TAN 00,329 R05D GLA

Actifed Compound,Syrup

Codeine Phosphate BP
Codeine Phosphate BP
Pseudoephedrine
Hydrochloride BP
Pseudoephedrine
Hydrochloride BP
Triprolidone Hydrochloride
BP
Triprolidone Hydrochloride
BP
1,189 TAN 00,397 R03B GLA

10 mg/5ml
10 mg/5ml
30 mg/5ml
30 mg/5ml
1.25 mg/5ml
1.25 mg/5ml

Ventolin G,Syrup

Salbutamol Sulphate
2 mg/10ml
equivalent to Salbutamol BP
Guaiphenesin Sulphate BP 100 mg/10ml
Page 188 of 584

Human Medicinal Products


S/No:

Registration Number

1,190 TAN 00, 590 J01C SMI

1,191 TAN 00,1070 D07A GLA

1,192 TAN 07,040 J03B GSK

1,193 TAN 00,1425 J05A GLA

1,194 TAN 00,1425 J05A GLA

1,195 TAN 00,1427 J01D GLA

1,196 TAN 00,1606 J05A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Clavulin,Tablet

Amoxicillin Trihydrate
875 mg
equivalent to Amoxicillin BP
Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid BP

24

Fluticasone Propionate IH

0.05 %w/w

24

Sulfamethoxazole Ph Eur
Trimethoprim Ph Eur

400 mg/5ml
80 mg/5ml

36

Zidovudine IH

50 mg/5ml

36

Zidovudine IH

50 mg/5ml

36

Cefuroxime USP

750 mg

24

Abacavir Sulphate IH

200 mg/ml

24

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Flixonase,Solution
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Septrin,Injectable Solution
Draxis Pharma Inc
CANADA

Retrovir,Syrup
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Retrovir,Syrup
Hilton Pharma (PVT) Ltd.
PAKISTAN

Zinacef,Powder for Injection


GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Ziagen,Solution

Page 189 of 584

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,197 TAN 09,142 A02B GSK

1,198 TAN 09,138 J02A GSK

1,199 TAN 09,143 J05A GSK

1,200 TAN 09,137 J05A GSK

1,201 TAN 09,141 J02A GSK

1,202 TAN 00,2150 R03A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Zantac,Injection

Ranitidine Hydrochloride Ph 50 mg/2ml


Eur

36

GlaxoSmithkline S.P.A
ITALY

Acetylsalicylic Acid USP

75 mg

15

USV Ltd.
INDIA

Zidovudine Ph Eur

10 mg/ml

24

GlaxoSmithKline Inc
CANADA

Lamivudine Ph Eur
Zidovudine Ph Eur

150 mg
300 mg

24

Fluconazole IH

50 mg/5ml

36

Ecoric 75,Tablet

Retrovil,Syrup

Combivir,Tablet
Aurobindo Pharma Ltd.
Unit III Formulations
INDIA

Zilcan,Suspension
Medreich Sterilab Ltd.
INDIA

Ventolin,Aerosol

Salbutamol Sulphate
0.1 mg/dose
equivalent to Salbutamol BP

1,203 TAN 00,2151 A02B GLA

Shelf life
month

36

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Zantac,Injectable Solution

Ranitidine Ph Eur

Page 190 of 584

50 mg/2ml

36

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,204 TAN 00,2153 R05D GLA

1,205 TAN 00,2149 D07A GLA

1,206 TAN 00,4285 D04A GLA

1,207 TAN 00,1818 J01D GLA

1,208 TAN 00,4284 R03A GLA

1,209 TAN 00,4286 R05D GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Piriton,Syrup
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Chlorpheniramine Maleate
BP

2 mg/5ml

36

Fluticasone Propionate BP

0.05 %w/w

24

Pseudoephedrine
Hydrochloride IH
Triprolidine Hydrochloride
IH

60 mg

36

Cefuroxime Axetil
equivalent to Cefuroxime
USP

250 mg

36

Salbutamol Sulphate eq
Salbutamol Ph Eur

2 mg

36

GlaxoSmithKline Egypt
EGYPT

36

GlaxoSmithKline Egypt
EGYPT

Cutivate,Cream
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Actifed,Tablet
GlaxoSmithKline Egypt
EGYPT

2.5 mg

Zinnat,Tablet
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Ventolin,Tablet

Actifed Compound,Syrup

Triprolidine Hydrochloride 1.25 mg


BP
Codeine Phosphate Ph Eur 10 mg
Pseudoephedrine
30 mg
Hydrochloride Ph Eur

Page 191 of 584

Human Medicinal Products


S/No:

Registration Number

1,210 TAN 00,397 R03B GLA

1,211 TAN 00,397 R03B GLA

1,212 TAN 00, 590 J01C SMI

1,213 TAN 00, 590 J01C SMI

1,214 TAN 00,1070 D07A GLA

1,215 TAN 00,1070 D07A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Ventolin G,Syrup

Salbutamol Sulphate
2 mg/10ml
equivalent to Salbutamol BP
Guaiphenesin Sulphate BP 100 mg/10ml

24

GlaxoSmithKline Egypt
EGYPT

Salbutamol Sulphate
2 mg/10ml
equivalent to Salbutamol BP
Guaiphenesin Sulphate BP 100 mg/10ml

24

GlaxoSmithKline Egypt
EGYPT

Amoxicillin Trihydrate
875 mg
equivalent to Amoxicillin BP
Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid BP

24

Amoxicillin Trihydrate
875 mg
equivalent to Amoxicillin BP
Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid BP

24

Fluticasone Propionate IH

0.05 %w/w

24

Fluticasone Propionate IH

0.05 %w/w

24

Ventolin G,Syrup

Clavulin,Tablet
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Clavulin,Tablet
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Flixonase,Solution
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Flixonase,Solution

Page 192 of 584

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,216 TAN 00,088 R05D GLA

1,217 TAN 00,317 A02B GLA

1,218 TAN 00,330 R05F GLA

1,219 TAN 00,561 R05A GLA

1,220 TAN 00,399 D07A GLA

1,221 TAN 00,416 J03B GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Cofta,Tablet

Menthol BP
Tincture of Capsicum BP
Glycyrrhiza Extract IH

9.98 mg
0.02 ml
35 mg

60

GlaxoSmithkline (K) Ltd.


KENYA

Ranitidine BP

150 mg

36

GlaxoSmithkline (K) Ltd.


KENYA

Guaiphenesin BP
Pseudoephedrine
Hydrochloride BP
Triprolidine Hydrochloride
BP

100 mg/5ml
30 mg/5ml

36

GlaxoSmithKline Egypt
EGYPT

Pseudoephedrine
Hydrochloride Ph Eur
Triprolidine Hydrochloride
Ph Eur

60 mg

48

GlaxoSmithKline Egypt
EGYPT

Clobetasol Propionate BP

0.0525 %w/w

24

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

36

Zantac,Tablet

Actifed,Syrup

1.25 mg/5ml

Actifed,Tablet

2.5 mg

Dermovate,Cream
GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Septrin,Suspension

Page 193 of 584

GlaxoSmithKline Egypt
EGYPT

Human Medicinal Products


S/No:

Registration Number

1,222 TAN 00,1607 J05A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

300 mg

24

Glaxo Operations UK Ltd.


UNITED KINGDOM

1g

36

GlaxoSmithkline S.P.A
ITALY

Atracurium Besylate Ph Eur 10 mg/ml

24

GlaxoSmithkline S.P.A
ITALY

Acetylsalicylic Acid USP

75 mg

15

USV Ltd.
INDIA

Zidovudine Ph Eur

10 mg/ml

24

GlaxoSmithKline Inc
CANADA

Fosamprenavir Calcium IHS 50 mg/5ml

24

Glaxo Operations UK Ltd.


UNITED KINGDOM

Fosamprenavir Calcium IHS 700 mg

36

Glaxo Operations UK Ltd.


UNITED KINGDOM

Fortum,Injectable Solution

Ceftazidine Pentahydrate
equivant to Ceftazidine Ph
Eur
1,224 TAN 00,1814 N02A GLA

1,225 TAN 09,138 J02A GSK

1,226 TAN 09,143 J05A GSK

1,227 TAN 05,771 J05A GSK

1,228 TAN 05,770 J05A GSK

Manufacturer

Ziagen,Tablet

Abacavir Sulphate BP

1,223 TAN 00,1426 J01D GLA

Shelf life
month

Tracrium,Injectable Solution

Ecoric 75,Tablet

Retrovil,Syrup

Telzir,Suspension

Telzir,Tablet

Page 194 of 584

Human Medicinal Products


S/No:

Registration Number

1,229 TAN 00,1427 J01D GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,231 TAN 06,148 J05A GSK

1,232 TAN 06,149 J02A GSK

1,233 TAN 06,150 J02A GSK

1,234 TAN 06,147 J02A GSK

1,235 TAN 00,1606 J05A GLA

Manufacturer

Zinacef,Powder for Injection


GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

750 mg

24

Cefuroxime USP

750 mg

24

Abacavir Sulphate IH
Lamivudine IH

600 mg
300 mg

36

Glaxo Operations UK Ltd.


UNITED KINGDOM

Fluconazole IH

200 mg

36

Medreich Sterilab Ltd.


INDIA

Fluconazole IH

50 mg

36

Medreich Sterilab Ltd.


INDIA

Fluconazole IH

150 mg

36

Medreich Sterilab Ltd.


INDIA

Abacavir Sulphate IH

200 mg/ml

24

Cefuroxime USP

1,230 TAN 00,1427 J01D GLA

Shelf life
month

Zinacef,Powder for Injection


GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Kivexa,Tablet

Zilcan,Capsules

Zilcan,Capsules

Zilcan,Capsules

Ziagen,Solution

Page 195 of 584

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,236 TAN 00,1606 J05A GLA

1,237 TAN 06,401 J01C GSK

1,238 TAN 06,400 R03A GSK

1,239 TAN 07,042 D06A GSK

1,240 TAN 00,2150 R03A GLA

1,241 TAN 00,2150 R03A GLA

1,242 TAN 00,2151 A02B GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Ziagen,Solution

Abacavir Sulphate IH

200 mg/ml

24

Amoxycillin Ph Eur
Clavulanic Acid Ph Eur

875 mg
125 mg

36

Salmeterol Xinafoate
25 mcg
equivalent to Salmeterol IH

24

Mupirocin Calcium IH

18

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Augmentin,Tablet
GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Serevent,Aerosol
Glaxo Wellcom Production
FRANCE

Bactroban,Cream
2 %w/w

SmithKline Beecham
Plc(Trading as SmithKline
Beech
UNITED KINGDOM

Ventolin,Aerosol

Salbutamol Sulphate
0.1 mg/dose
equivalent to Salbutamol BP

36

Salbutamol Sulphate
0.1 mg/dose
equivalent to Salbutamol BP

36

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Ventolin,Aerosol
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Zantac,Injectable Solution

Ranitidine Ph Eur

Page 196 of 584

50 mg/2ml

36

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,243 TAN 00,2151 A02B GLA

1,244 TAN 00,2149 D07A GLA

1,245 TAN 00,2149 D07A GLA

1,246 TAN 00,2153 R05D GLA

1,247 TAN 00,1990 P01B LAB

1,248 TAN 07,304 R03A GSK

1,249 TAN 07,306 R03A GSK

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Zantac,Injectable Solution

Ranitidine Ph Eur

50 mg/2ml

36

Fluticasone Propionate BP

0.05 %w/w

24

Fluticasone Propionate BP

0.05 %w/w

24

Chlorpheniramine Maleate
BP

2 mg/5ml

36

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Cutivate,Cream
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Cutivate,Cream
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Piriton,Syrup
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Halfan,Suspension

Halofantrine Hydrochloride 100 mg/5ml


IH

36

Salmeterol Xinafoate
25 mcg
equivalent to Salmeterol Ph
Eur
50 mcg
Fluticasone Propionate IH

24

Laboratories SmithKline &


French, S.A
FRANCE

Seretide,Inhaler

Seretide,Inhaler

Page 197 of 584

Glaxo Wellcom Production


FRANCE

Human Medicinal Products


S/No:

Registration Number

1,250 TAN 07,305 A10B GSK

1,251 TAN 00,1424 P01B GLA

1,252 TAN 00,4285 D04A GLA

1,253 TAN 00,1818 J01D GLA

1,254 TAN 00,4286 R05D GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Salmeterol Xinafoate
25 mcg
equivalent to Salmeterol Ph
Eur
Fluticasone Propionate Ph 125 mcg
Eur

18

Glaxo Wellcom Production


FRANCE

Rosiglitazone Maleate
Eur/USP

24

Glaxo Wellcome S.A


SPAIN

Proguanil Hydrochloride Ph 100 mg


Eur
250 mg
Atovaquone IH

36

GlaxoSmithKline Inc
CANADA

Pseudoephedrine
Hydrochloride IH
Triprolidine Hydrochloride
IH

60 mg

36

GlaxoSmithKline Egypt
EGYPT

Cefuroxime Axetil
equivalent to Cefuroxime
USP

250 mg

Avandia,Tablet
4 mg

Malanil,Tablet

Actifed,Tablet

2.5 mg

Zinnat,Tablet
36

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Actifed Compound,Syrup

Triprolidine Hydrochloride 1.25 mg


BP
Codeine Phosphate Ph Eur 10 mg
Pseudoephedrine
30 mg
Hydrochloride Ph Eur

Page 198 of 584

36

GlaxoSmithKline Egypt
EGYPT

Human Medicinal Products


S/No:

Registration Number

1,255 TAN 08,134 M03A GSK

Product Name
Pack and Pack size

Ingredient(s) and Strength

2 mg/ml

24

GlaxoSmithkline S.P.A
ITALY

1g

36

GlaxoSmithkline S.P.A
ITALY

Human Papillomavirus type 20 mcg


16 L1 Protein IH
Human Papillomavirus type 20 mcg
18 L1 Protein IH
3 - O - deacyl- 450 mcg
monophosphoryl lipid A IH

36

GlaxoSmithKline Biologicals
BELGIUM

Cefuroxime Axetil Ph Eur

250 mg

36

Cefuroxime Axetil Ph Eur

500 mg

36

Fortum,Injectable Solution

Ceftazidine Pentahydrate
equivant to Ceftazidine Ph
Eur
1,257 TAN 08,160 J07A GSK

1,258 TAN 09,045 J01D GSK

1,259 TAN 09,044 J01D GSK

1,260 TAN 07,041 J01C GSK

Manufacturer

Nimbex,Injection

Cisatricurium Besylate IH

1,256 TAN 00,1426 J01D GLA

Shelf life
month

Cervarix,Suspension

Proximexa,Tablet
GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Proximexa,Tablet
GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Augmentin,Syrup

Clavulanate Potassium Ph 59.85 mg/5ml


Eur
Amoxicillin Trihydrate
400 mg/5ml
equivalent to Amoxicillin Ph
Eur

Page 199 of 584

18

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,261 TAN 10,012 A11A GSK

1,262 TAN 00,088 R05D GLA

1,263 TAN 00,317 A02B GLA

1,264 TAN 00,561 R05A GLA

1,265 TAN 00,399 D07A GLA

1,266 TAN 00,416 J03B GLA

1,267 TAN 00,1607 J05A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Relenza Rotadisk,Powder

Zanamivir IH

5 mg

60

Glaxo Wellcom Production


FRANCE

Menthol BP
Tincture of Capsicum BP
Glycyrrhiza Extract IH

9.98 mg
0.02 ml
35 mg

60

GlaxoSmithkline (K) Ltd.


KENYA

Ranitidine BP

150 mg

36

GlaxoSmithkline (K) Ltd.


KENYA

Pseudoephedrine
Hydrochloride Ph Eur
Triprolidine Hydrochloride
Ph Eur

60 mg

48

GlaxoSmithKline Egypt
EGYPT

Clobetasol Propionate BP

0.0525 %w/w

24

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

36

GlaxoSmithKline Egypt
EGYPT

Abacavir Sulphate BP

300 mg

24

Glaxo Operations UK Ltd.


UNITED KINGDOM

Cofta,Tablet

Zantac,Tablet

Actifed,Tablet

2.5 mg

Dermovate,Cream
GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Septrin,Suspension

Ziagen,Tablet

Page 200 of 584

Human Medicinal Products


S/No:

Registration Number

1,268 TAN 00,1426 J01D GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

1g

36

GlaxoSmithkline S.P.A
ITALY

1g

36

GlaxoSmithkline S.P.A
ITALY

Atracurium Besylate Ph Eur 10 mg/ml

24

GlaxoSmithkline S.P.A
ITALY

Proguanil Hydrochloride Ph 100 mg


Eur
250 mg
Atovaquone IH

36

GlaxoSmithKline Inc
CANADA

Sulfamethoxazole Ph Eur
Trimethoprim Ph Eur

400 mg
80 mg

60

GlaxoSmithKline Egypt
EGYPT

300 mg
250 mg

60

GlaxoSmithKline Egypt
EGYPT

Fortum,Injectable Solution

Ceftazidine Pentahydrate
equivant to Ceftazidine Ph
Eur
1,270 TAN 00,1814 N02A GLA

1,271 TAN 00,1424 P01B GLA

1,272 TAN 00,4282 J03B GLA

Registrant
1,273 TAN 00,355 M03B AMO

Tracrium,Injectable Solution

Malanil,Tablet

Septrin,Tablet

GlaxoSmithKline Egypt - EGYPT


Myolgin,Capsules

Paracetamol BP
Chlorzoxazone USP

Registrant

Manufacturer

Fortum,Injectable Solution

Ceftazidine Pentahydrate
equivant to Ceftazidine Ph
Eur
1,269 TAN 00,1426 J01D GLA

Shelf life
month

GlaxoSmithKline International - UNITED KINGDOM

Page 201 of 584

Human Medicinal Products


S/No:

Registration Number

1,274 TAN 00,271 J05A SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,276 TAN 00,291 J01F SKB

1,277 TAN 00,2203 J01D SKB

1,278 TAN 00,2203 J01D SKB

1,279 TAN 00,288 P02X SKB

1,280 TAN 00,265 P02X SKB

Manufacturer

Penbritin,Powder for Injection


Karnataka Antibiotics &
Pharmaceuticals Ltd.
INDIA

250 mg

36

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

36

Erythromycin Stearate
equivalent to Erythromycin
BP

250 mg

24

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

Medreich Sterilab Ltd.


INDIA

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

Hilton Pharma (PVT) Ltd.


PAKISTAN

Metronidazole BP

200 mg

36

Medreich Sterilab Ltd.


INDIA

Albendazole USP

200 mg/5ml

36

Ampicillin Trihydrate
equivalent to Ampicillin BP

1,275 TAN 00,271 J05A SKB

Shelf life
month

Penbritin,Powder for Injection


Hilton Pharma (PVT) Ltd.
PAKISTAN

Rythro,Tablet
GlaxoSmithKline
Pharmaceuticals (India) Ltd.
INDIA

Penamox,Capsules

Penamox,Capsules

Zagole,Tablet

Azentel,Suspension

Page 202 of 584

Medreich Formulation Pvt


Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,281 TAN 00,266 P02X SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,284 TAN 00,266 P02X SKB

1,285 TAN 00,265 P02X SKB

1,286 TAN 00,265 P02X SKB

1,287 TAN 00,266 P02X SKB

Medreich Formulation Pvt


Ltd.
INDIA

400 mg

36

10 mcg

36

GlaxoSmithKline Biologicals
BELGIUM

Hepatitis B Vaccine IH

20 mcg

36

GlaxoSmithKline Biologicals
BELGIUM

Albendazole USP

400 mg

36

Albendazole USP

200 mg/5ml

36

Albendazole USP

200 mg/5ml

36

Albendazole USP

400 mg

36

Engerix B,Injectable Solution

Hepatitis B Vaccine IH

1,283 TAN 05,644 J07A GSK

Manufacturer

Azentel,Tablet

Albendazole USP

1,282 TAN 05,645 J07A GSK

Shelf life
month

Engerix B,Injectable Solution

Azentel,Tablet
Medreich Formulation Pvt
Ltd.
INDIA

Azentel,Suspension
Medreich Formulation Pvt
Ltd.
INDIA

Azentel,Suspension
Medreich Formulation Pvt
Ltd.
INDIA

Azentel,Tablet

Page 203 of 584

Medreich Formulation Pvt


Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,288 TAN 00,266 P02X SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,293 TAN 00,1520 J01C SKB

36

GlaxoSmithKline Biologicals
BELGIUM

10 mcg

36

GlaxoSmithKline Biologicals
BELGIUM

20 mcg

36

GlaxoSmithKline Biologicals
BELGIUM

20 mcg

36

GlaxoSmithKline Biologicals
BELGIUM

Engerix B,Injectable Solution

Hepatitis B Vaccine IH

Registrant

10 mcg

Engerix B,Injectable Solution

Hepatitis B Vaccine IH

1,292 TAN 05,644 J07A GSK

36

Engerix B,Injectable Solution

Hepatitis B Vaccine IH

1,291 TAN 05,644 J07A GSK

Medreich Formulation Pvt


Ltd.
INDIA

400 mg

Engerix B,Injectable Solution

Hepatitis B Vaccine IH

1,290 TAN 05,645 J07A GSK

Manufacturer

Azentel,Tablet

Albendazole USP

1,289 TAN 05,645 J07A GSK

Shelf life
month

GlaxoSmithKline Ltd. - KENYA


Clavulin,Powder for
Suspension

Potassium Clavulanate eq to 28 mg/5ml


Clavulanic Acid BP
Amoxicillin Trihydrate
200 mg/5ml
equivalent to Amoxicillin Ph
Eur

Page 204 of 584

24

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,294 TAN 00,400 D07A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,296 TAN 00,1708 J01H SKB

1,297 TAN 00,1711 J01C SKB

1,298 TAN 00,1712 J01C SKB

1,299 TAN 09,144 J05A GSK

1,300 TAN 00,1713 J01C SKB

Manufacturer

Dermovate,Ointment
0.05 %w/w

24

Mupirocin Calcium IH

2 %w/w

24

Amoxicillin Trihydrate BP

250 mg/5ml

24

Amoxicillin Trihydrate Ph
Eur

250 mg

60

Clobesol Propionate IH

1,295 TAN 00,1707 D06A SKB

Shelf life
month

GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Bactroban,Ointment
GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Amoxil,Suspension
GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Amoxil,Capsules
GlaxoSmithKline
International
UNITED KINGDOM

Amoxil,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

60

Lamivudine IH

24

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Epivir,Syrup

Ampiclox,Capsules

Page 205 of 584

10 mg/ml

GlaxoSmithKline Inc
CANADA

Human Medicinal Products


S/No:

Registration Number

1,301 TAN 00,4108 N02B GLA

1,302 TAN 00,1697 N02B SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,304 TAN 00,1296 N02B SKB

1,305 TAN 00,1297 N02B SKB

1,306 TAN 00,1521 J01C SKB

Manufacturer

Ampicillin Sodium
250 mg
equivalent to Ampicillin Ph
Eur
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin Ph
Eur

36

Medreich Sterilab Ltd.


INDIA

Paracetamol IH

120 mg/5ml

36

GlaxoSmithKline Egypt
EGYPT

65 mg
500 mg

60

GlaxoSmithkline (K) Ltd.


KENYA

Calpol,Suspension

Panadol Extra,Tablet

Caffeine Ph Eur
Paracetamol Ph Eur

1,303 TAN 00,1077 D07A GLA

Shelf life
month

Betnovate,Cream
GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Betamethasone Valerate Ph 0.1 %w/w


Eur

24

Acetaminophen USP

500 mg

60

GlaxoSmithKline Ltd.
KENYA

Paracetamol BP
Caffeine Ph Eur
Acetylsalicylic Acid USP

200 mg
50 mg
400 mg

36

GlaxoSmithkline (K) Ltd.


KENYA

Flucloxacillin Sodium Ph
Eur

250 mg

36

Panadol,Tablet

Hedex,Tablet

Floxapen,Capsules

Page 206 of 584

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,307 TAN 00,2045 P02X SKB

1,308 TAN 00,2045 P02X SKB

1,309 TAN 00,1816 D04A GLA

1,310 TAN 00,4281 R06A GLA

1,311 TAN 00,4598 A07D GSK

1,312 TAN 05,178 J01A GSK

1,313 TAN 00,283 J01H SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Zentel,Suspension

Albendazole IH

400 mg

60

Glaxo Wellcome Production


FRANCE

Albendazole IH

400 mg

60

Glaxo Wellcome Production


FRANCE

Chlorpheniramine Maleate
BP

4 mg

36

GlaxoSmithKline Ltd.
KENYA

Chlorpheniramine Maleate
BP
Ammonium Chloride BP

4 mg/10ml

36

GlaxoSmithKline Ltd.
KENYA

Loperamide Hydrochloride
USP

2 mg

36

Medreich Sterilab Ltd.


INDIA

Doxycycline Hyclate BP

100 mg

36

Medreich Sterilab Ltd.


INDIA

36

Medreich Sterilab Ltd.


INDIA

Zentel,Suspension

Piriton,Tablet

Piriton,Syrup

200 mg/10ml

Diocalm,Capsules

Eskadox,Capsules

Penamox,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

Page 207 of 584

Human Medicinal Products


S/No:

Registration Number

1,314 TAN 00,318 A02B GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

300 mg

36

0.05 %w/w

24

Ampiclox
Neonatal,Suspension

Ampicillin Trihydrate
60 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
30 mg
equivalent to Cloxacillin BP

1,317 TAN 00,1517 J01C SKB

1,318 TAN 00,1518 A02A SKB

1,319 TAN 00,1519 A02A SKB

36

GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Floxapen,Suspension

Flucloxacillin Sodium BP

125 mg/5ml

36

Sodium Bicarbonate BP
Sodium Carbonate BP

2.06 g
0.45 g

24

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Lemon Eno,Powder
GlaxoSmithKline Ltd.
KENYA

Actal Tums,Tablet

Calcium Carbonate Ph Eur 500 mg

1,320 TAN 00,1704 J01C SKB

GlaxoSmithKline Egypt
EGYPT

Dermovate,Ointment

Clobesol Propionate IH

1,316 TAN 00,1700 J01C SKB

Manufacturer

Zantac,Tablet

Ranitidine BP

1,315 TAN 00,400 D07A GLA

Shelf life
month

Augmentin,Powder for
Injection

Potassium Clavulanate eq to 200 mg


Clavulanic Acid Ph Eur
Amoxicillin Sodium Ph Eur 1000 mg

Page 208 of 584

60

24

GlaxoSmithKline
International
UNITED KINGDOM

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,321 TAN 00,1710 J01C SKB

1,322 TAN 09,144 J05A GSK

1,323 TAN 00,1520 J01C SKB

1,324 TAN 00,1520 J01C SKB

1,325 TAN 00,085 R05D GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Amoxil,Capsules

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

60

Lamivudine IH

24

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Epivir,Syrup

Clavulin,Powder for
Suspension

Clavulin,Powder for
Suspension

10 mg/ml

Potassium Clavulanate eq to 28 mg/5ml


Clavulanic Acid BP
Amoxicillin Trihydrate
200 mg/5ml
equivalent to Amoxicillin Ph
Eur

24

Potassium Clavulanate eq to 28 mg/5ml


Clavulanic Acid BP
Amoxicillin Trihydrate
200 mg/5ml
equivalent to Amoxicillin Ph
Eur

24

GlaxoSmithKline Inc
CANADA

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Bronchomint,Syrup

Anise Oil BP
Peppermint oil
dementholised BP
Vinegar of Ipecac IH
1,326 TAN 00,1707 D06A SKB

Shelf life
month

0.0002 ml/5ml
0.03 ml/5ml

36

GlaxoSmithkline (K) Ltd.


KENYA

0.159 g/5ml

Bactroban,Ointment

Mupirocin Calcium IH

Page 209 of 584

2 %w/w

24

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,327 TAN 00,1708 J01H SKB

1,328 TAN 00,1711 J01C SKB

1,329 TAN 00,1712 J01C SKB

1,330 TAN 00,964 G01A AMO

1,331 TAN 00,357 N04C AMO

1,332 TAN 00,1705 J01C SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Amoxil,Suspension

Amoxicillin Trihydrate BP

250 mg/5ml

24

Amoxicillin Trihydrate Ph
Eur

250 mg

60

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Amoxil,Capsules
GlaxoSmithKline
International
UNITED KINGDOM

Amoxil,Suspension
GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

60

Econazole Nitrate BP

150 mg

36

GlaxoSmithKline Egypt
EGYPT

Bromazepam IH

3 mg

48

GlaxoSmithKline Egypt
EGYPT

100 mg

24

Gynoryl,Pessaries

Calmepam,Tablet

Augmentin,Powder for
Injection

Potassium Clavunate
Equivalent to Clavulanic
Acid Ph Eur
Amoxicillin Sodium Ph Eur

1,333 TAN 08,059 J01D GSK

Shelf life
month

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

500 mg

Proximexa,Suspension

Cefuroxime Axetil Ph Eur

Page 210 of 584

125 mg/5ml

24

GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Human Medicinal Products


S/No:

Registration Number

1,334 TAN 08,058 J01D GSK

Product Name
Pack and Pack size

Ingredient(s) and Strength

250 mg/5ml

1,337 TAN 00,1713 J01C SKB

1,338 TAN 00,4108 N02B GLA

1,339 TAN 00,1697 N02B SKB

24

GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Augmentin,Tablet

Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid Ph Eur
Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin Ph
Eur
1,336 TAN 00,1714 J01H SKB

Manufacturer

Proximexa,Oral Suspension

Cefuroxime Axetil Ph Eur

1,335 TAN 00,348 J01C SKB

Shelf life
month

36

GlaxoSmithKline
International
UNITED KINGDOM

Ampiclox,Suspension

Cloxacillin Sodium
125 mg/5ml
equivalent to Cloxacillin BP
Ampicillin Trihydrate
125 mg/5ml
equivalent to Ampicillin BP

36

Medreich Sterilab Ltd.


INDIA

Ampicillin Sodium
250 mg
equivalent to Ampicillin Ph
Eur
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin Ph
Eur

36

Medreich Sterilab Ltd.


INDIA

Paracetamol IH

120 mg/5ml

36

GlaxoSmithKline Egypt
EGYPT

65 mg
500 mg

60

GlaxoSmithkline (K) Ltd.


KENYA

Ampiclox,Capsules

Calpol,Suspension

Panadol Extra,Tablet

Caffeine Ph Eur
Paracetamol Ph Eur

Page 211 of 584

Human Medicinal Products


S/No:

Registration Number

1,340 TAN 00,1077 D07A GLA

1,341 TAN 00,1296 N02B SKB

1,342 TAN 00,1521 J01C SKB

1,343 TAN 00,1521 J01C SKB

1,344 TAN 00,2045 P02X SKB

1,345 TAN 00,1816 D04A GLA

1,346 TAN 00,1702 J01C SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Betnovate,Cream
GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Betamethasone Valerate Ph 0.1 %w/w


Eur

24

Acetaminophen USP

500 mg

60

Flucloxacillin Sodium Ph
Eur

250 mg

36

Flucloxacillin Sodium Ph
Eur

250 mg

36

Albendazole IH

400 mg

60

Glaxo Wellcome Production


FRANCE

Chlorpheniramine Maleate
BP

4 mg

36

GlaxoSmithKline Ltd.
KENYA

Panadol,Tablet
GlaxoSmithKline Ltd.
KENYA

Floxapen,Capsules
GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Floxapen,Capsules
GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Zentel,Tablets

Piriton,Tablet

Augmentin,Tablet

Page 212 of 584

Human Medicinal Products


S/No:

Registration Number

1,347 TAN 00,4281 R06A GLA

1,348 TAN 00,283 J01H SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,351 TAN 00,1518 A02A SKB

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

36

Chlorpheniramine Maleate
BP
Ammonium Chloride BP

36

GlaxoSmithKline Ltd.
KENYA

36

Medreich Sterilab Ltd.


INDIA

Piriton,Syrup
4 mg/10ml
200 mg/10ml

Penamox,Suspension

Augmentin BD,Syrup

Clavulanate Potassium BP 28.5 mg/5ml


Amoxicillin Trihydrate
200 mg/5ml
equivalent to Amoxicillin Ph
Eur
1,350 TAN 00,1700 J01C SKB

Manufacturer

Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid Ph Eur
Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

1,349 TAN 00,384 J01C SKB

Shelf life
month

Ampiclox
Neonatal,Suspension

24

Ampicillin Trihydrate
60 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
30 mg
equivalent to Cloxacillin BP

36

Sodium Bicarbonate BP
Sodium Carbonate BP

24

SmithKline Beecham
Plc(Trading as SmithKline
Beech
UNITED KINGDOM

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Lemon Eno,Powder

Page 213 of 584

2.06 g
0.45 g

GlaxoSmithKline Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

1,352 TAN 00,1519 A02A SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,354 TAN 00,1710 J01C SKB

1,355 TAN 00,1905 A02A SKB

Augmentin,Powder for
Injection

1,357 TAN 09,049 J05A GLA

1,358 TAN 09,047 J05A GLA

60

Potassium Clavulanate eq to 200 mg


Clavulanic Acid Ph Eur
Amoxicillin Sodium Ph Eur 1000 mg

24

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

60

GlaxoSmithKline
International
UNITED KINGDOM

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Amoxil,Capsules

Andrews Liver Salts


Regular,Powder for
Magnesium Sulphate USP
Reconstitution

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

SmithKline Beecham
Consumer Health Care Ltd.
KENYA

0.88 g/5g
2.28 g/5g

24

Paracetamol Ph Eur

120 mg/5ml

36

Glaxo Wellcome.
FRANCE

Abacavir Sulphate IH

20 mg/ml

24

GlaxoSmithKline Inc
CANADA

Abacavir Sulphate IH

300 mg

36

GlaxoSmithkline Operations
UNITED KINGDOM

Sodium Bicarbonate USP

1,356 TAN 09,046 N02B GSK

Manufacturer

Actal Tums,Tablet

Calcium Carbonate Ph Eur 500 mg

1,353 TAN 00,1704 J01C SKB

Shelf life
month

Panadol,Suspension

Ziagen,Suspension

Ziagen,Tablet

Page 214 of 584

Human Medicinal Products


S/No:

Registration Number

1,359 TZ10H028

1,360 TZ10H022

1,361 TZ11H004

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,363 TAN 00,318 A02B GLA

1,364 TAN 00,400 D07A GLA

Lamivudine IH
Zidovudine IH

150 mg
300 mg

24

Aspen Pharmacare Ltd


SOUTH AFRICA

Lamivudine IH

150 mg

24

Aspen Pharmacare Ltd


SOUTH AFRICA

0.0275 mcg/actuation

36

Epivir,Tablet

Avamys,Nasal Spray
GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Penamox,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

36

Medreich Sterilab Ltd.


INDIA

Ranitidine BP

300 mg

36

GlaxoSmithKline Egypt
EGYPT

0.05 %w/w

24

125 mg/5ml

36

Zantac,Tablet

Dermovate,Ointment

Clobesol Propionate IH

1,365 TAN 00,1517 J01C SKB

Manufacturer

Combivir,Tablet

Fluticasone Furoate
(micronised)
GlaxoSmithKline
1,362 TAN 00,283 J01H SKB

Shelf life
month

GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Floxapen,Suspension

Flucloxacillin Sodium BP

Page 215 of 584

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,366 TAN 00,1518 A02A SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

2.06 g
0.45 g

1,369 TAN 00,1710 J01C SKB

1,370 TZ11H011

1,371 TZ10H124

1,372 TZ10H132

24

GlaxoSmithKline Ltd.
KENYA

Actal Tums,Tablet

Calcium Carbonate Ph Eur 500 mg

1,368 TAN 00,1704 J01C SKB

Manufacturer

Lemon Eno,Powder

Sodium Bicarbonate BP
Sodium Carbonate BP

1,367 TAN 00,1519 A02A SKB

Shelf life
month

Augmentin,Powder for
Injection

60

Potassium Clavulanate eq to 200 mg


Clavulanic Acid Ph Eur
Amoxicillin Sodium Ph Eur 1000 mg

24

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

60

GlaxoSmithKline
International
UNITED KINGDOM

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Amoxil,Capsules
GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Panadol Advance,Tablet

Paracetamol Ph Eur

500 mg

24

Albendazole IH

400 mg

60

Artemether Ph Eur
Lumefantrine Ph Eur

20 mg
120 mg

36

GlaxoSmithKline
Dungarvan Ltd.
REPUBLIC OF IRELAND

Zentel,Suspension
GlaxoSmithKline South
Africa (Pty) Limited
SOUTH AFRICA

Colart,Tablets

Page 216 of 584

IPCA Laboratories Ltd.


INDIA

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

1,373 TAN 00,085 R05D GLA

Bronchomint,Syrup

Ingredient(s) and Strength

Anise Oil BP
Peppermint oil
dementholised BP
Vinegar of Ipecac IH
1,374 TAN 00,085 R05D GLA

Panadol Sinus Relief


PE,Caplets

Paracetamol BP
Phenylephrine
Hydrochloride BP

1,376 TAN 00,1705 J01C SKB

Augmentin,Powder for
Injection

Potassium Clavunate
Equivalent to Clavulanic
Acid Ph Eur
Amoxicillin Sodium Ph Eur

1,377 TAN 00,348 J01C SKB

1,378 TAN 00,348 J01C SKB

Manufacturer

36

GlaxoSmithkline (K) Ltd.


KENYA

36

GlaxoSmithkline (K) Ltd.


KENYA

0.159 g/5ml

Bronchomint,Syrup

Anise Oil BP
Peppermint oil
dementholised BP
Vinegar of Ipecac IH
1,375 TZ11H019

0.0002 ml/5ml
0.03 ml/5ml

Shelf life
month

0.0002 ml/5ml
0.03 ml/5ml
0.159 g/5ml

500 mg
5 mg

24

100 mg

24

GlaxoSmithKline Australia
Pty Ltd
AUSTRALIA

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

500 mg

Augmentin,Tablet

Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid Ph Eur
Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin Ph
Eur

36

Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid Ph Eur
Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin Ph
Eur

36

GlaxoSmithKline
International
UNITED KINGDOM

Augmentin,Tablet

Page 217 of 584

GlaxoSmithKline
International
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,379 TAN 00,1714 J01H SKB

1,380 TAN 00,1702 J01C SKB

1,381 TAN 00,384 J01C SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,382 TAN 00,1072 J05A GLA

1,383 TAN 00,722 J05A GLA

1,384 TAN 00,1073 D07A GLA

Manufacturer

Ampiclox,Suspension

Cloxacillin Sodium
125 mg/5ml
equivalent to Cloxacillin BP
Ampicillin Trihydrate
125 mg/5ml
equivalent to Ampicillin BP

36

Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid Ph Eur
Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

36

Medreich Sterilab Ltd.


INDIA

Augmentin,Tablet
GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Augmentin BD,Syrup

Clavulanate Potassium BP 28.5 mg/5ml


Amoxicillin Trihydrate
200 mg/5ml
equivalent to Amoxicillin Ph
Eur

Registrant

Shelf life
month

24

SmithKline Beecham
Plc(Trading as SmithKline
Beech
UNITED KINGDOM

GlaxoSmithkline Operations(UK) Ltd. - UNITED KINGDOM


Epivir,Solution

Lamivudine IH

10 mg/ml

24

Lamivudine IH
Zidovudine IH

150 mg
300 mg

24

0.05 %w/w

36

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Combivir,Tablet
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Eumovate,Ointment

Clobetasone Butylate Ph
Eur

Page 218 of 584

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,385 TAN 00,1074 D07A GLA

1,386 TAN 00,1075 J01D GLA

1,387 TAN 09,145 R03A GSK

1,388 TAN 00,4204 J01D GLA

1,389 TAN 00,722 J05A GLA

1,390 TAN 00,722 J05A GLA

1,391 TAN 00,1073 D07A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Eumovate,Cream

Clobetasone Butylate Ph
Eur

0.05 %w/w

24

Cefuroxime Axetil BP

250 mg/5ml

24

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Zinnat,Suspension
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Ventolin evohaler,Inhaler

Salbutamol Sulphate
120.5 mcg/actuation
equivalent to Salbutamol IH

24

GlaxoSmithkline Operations
UNITED KINGDOM

Ceftazidime Pentahydrate
IH

1g

36

GlaxoSmithkline S.P.A
ITALY

Lamivudine IH
Zidovudine IH

150 mg
300 mg

24

Lamivudine IH
Zidovudine IH

150 mg
300 mg

24

0.05 %w/w

36

Fortum,Injection

Combivir,Tablet
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Combivir,Tablet
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Eumovate,Ointment

Clobetasone Butylate Ph
Eur

Page 219 of 584

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,392 TAN 00,1073 D07A GLA

1,393 TAN 00,1074 D07A GLA

1,394 TAN 00,1074 D07A GLA

1,395 TAN 00,1075 J01D GLA

1,396 TAN 00,1075 J01D GLA

1,397 TAN 00,1075 J01D GLA

1,398 TAN 00,721 J05A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Eumovate,Ointment

Clobetasone Butylate Ph
Eur

0.05 %w/w

36

Clobetasone Butylate Ph
Eur

0.05 %w/w

24

Clobetasone Butylate Ph
Eur

0.05 %w/w

24

Cefuroxime Axetil BP

250 mg/5ml

24

Cefuroxime Axetil BP

250 mg/5ml

24

Cefuroxime Axetil BP

250 mg/5ml

24

Zidovudine IH

100 mg

36

GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Eumovate,Cream
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Eumovate,Cream
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Zinnat,Suspension
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Zinnat,Suspension
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Zinnat,Suspension
GlaxoSmithkline
Operations(UK) Ltd.
UNITED KINGDOM

Retrovir,Capsules

Page 220 of 584

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

1,399 TAN 00,721 J05A GLA

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,400 TAN 00,1078 A02A GLE

1,401 TAN 00,4553 A12A GLE

1,402 TAN 00,4552 A02B GLE

1,403 TAN 05,497 D01A GLE

1,404 TAN 05,646 J01K GLE

Manufacturer

Retrovir,Capsules

Zidovudine IH

Registrant

Shelf life
month

100 mg

36

GlaxoSmithKline
Pharmaceuticals
UNITED KINGDOM

Glenmark Pharmaceuticals Ltd. - INDIA


Relcer,Gel
48

Deglycelizinated Liquorice
gel IH
Simethicone USP
Magnesium Hydroxide USP
Aluminium Hydroxide USP

400 mg/5ml

Cholecalciferol IH
Calcium Citrate USP

200 IU
1000 mg

24

Esomeprazole Magnesium
Trihydrate IH
Esomeprazole Magnesium
Trihydrate IHS
Esomeprazole Magnesium
Trihydrate equivalent to
Esomeprazole IH

40 mg

24

Clotrimazole USP

1 %w/v

36

Linezolid IH

600 mg

24

100 mg/5ml
80 mg/5ml
365 g/5ml

Glenmark Pharmaceuticals
Ltd.
INDIA

Milical,Tablet
Glenmark Pharmaceuticals
Ltd
INDIA

Esoz 40,Tablet

40 mg

Glenmark Pharmaceuticals
Ltd
INDIA

40 mg

Candid,Lotion
Glenmark Pharmaceuticals
Ltd
INDIA

Lizolid,Tablet

Page 221 of 584

Glenmark Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,405 TAN 06,290 A10B GLE

1,406 TAN 06,291 D07A GLE

1,407 TAN 06,348 D11A GLE

1,408 TAN 06,292 D07A GLE

1,409 TAN 06,288 A10B GLE

1,410 TAN 06,293 J01F GLE

1,411 TAN 06,289 J01F GLE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Rosicon-2,Tablet

Rosiglitazone Maleate
equivalent to Rosiglitazone
IH

2 mg

24

Clobetasol Propionate BP

0.05 %w/w

24

Beclomethasone
Dipropionate BP
Chloramphenicol BP

0.025 %w/v

18

Glenmark Pharmaceuticals
Ltd.
INDIA

Powercort,Cream

candibiotic Ear
Drops,Solution

5 %w/v

Glenmark Pharmaceuticals
Ltd.
INDIA

Glenmark Pharmaceuticals
Ltd.
INDIA

Momate Cream,Cream

Mometasone Furoate USP

0.1 %

24

Rosiglitazone Maleate
equivalent to Rosiglitazone
IH

5.4 mg

24

Clarithromycin USP

500 mg

24

Clarithromycin USP

250 mg

24

Glenmark Pharmaceuticals
Ltd.
INDIA

Rosicon-4,Tablet
Glenmark Pharmaceuticals
Ltd.
INDIA

Maclar-500,Tablet
Glenmark Pharmaceuticals
Ltd.
INDIA

Maclar-250,Tablet

Page 222 of 584

Glenmark Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,412 TAN 07,179 J02A GLE

1,413 TAN 07,180 J02A GLE

1,414 TAN 07,308 V03A GLE

1,415 TAN 00,1821 D01A GLE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Fluconazole IH

150 mg

24

Fluconazole IH

200 mg

24

Sibutramine Hydrochloride
Monohydrate IH

10 mg

24

2 %w/v
1 %w/v

24

1,418 TAN 05,646 J01K GLE

Glenmark Pharmaceuticals
Ltd
INDIA

Fluconazole,Tablet
Glenmark Pharmaceuticals
Ltd
INDIA

Sibutrim,Capsules
Glenmark Pharmaceuticals
Ltd
INDIA

Keto Plus Shampoo,Solution


Glenmark Pharmaceuticals
Ltd.
INDIA

Mumfer,Syrup
5

1,417 TAN 05,497 D01A GLE

Manufacturer

Fluconazole,Tablet

Ketoconazole BP
Zinc Pyrithione IH

1,416 TAN 07, 307 B03A GLE

Shelf life
month

Glenmark Pharmaceuticals
Ltd
INDIA

Candid,Lotion

Clotrimazole USP

1 %w/v

36

Linezolid IH

600 mg

24

Glenmark Pharmaceuticals
Ltd
INDIA

Lizolid,Tablet

Page 223 of 584

Glenmark Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,419 TZ10H120

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,420 TAN 05,110 D01A GLO

1,421 TAN 05,111 C01E GLO

1,422 TAN 05,113 C01E GLO

1,423 TAN 05,112 M01A GLO

Registrant
1,424 TAN 05,772 J01H GLO

Manufacturer

Candid V-1,Pessaries

Clotrimazole USP

Registrant

Shelf life
month

500 mg

48

Glenmark Pharmaceuticals
Ltd
INDIA

global marine products co llc - U.A.E


Tiocon,Cream

Tioconazole USP

1%

36

Lisinopril Dihydrate USP

10 mg

36

Lisinopril Dihydrate USP

5 mg

36

Tenoxicam BP

20 mg

36

global marine products co


llc
U.A.E

Sinopril,Tablet
global marine products co
llc
U.A.E

Sinopril,Tablet
global marine products co
llc
U.A.E

Soral,Capsules
global marine products co
llc
U.A.E

Global Pharma.Co. LLC - UNITED ARAB EMIRATES


Glomox,Capsules

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

Page 224 of 584

54

Global Pharma.Co. LLC


UNITED ARAB EMIRATES

Human Medicinal Products


S/No:

Registration Number

1,425 TAN 05,773 A02B GLO

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,427 TAN 06,294 J01C GLO

Registrant
1,428 TAN 07,181 P01B GUI

1,429 TAN 08,008 P01B GUI

Registrant
1,430 TAN 10, 014 A11A GUL

Manufacturer

Glotac,Tablet
150 mg

54

Global Pharma.Co. LLC


UNITED ARAB EMIRATES

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin
USP

24

Global Pharma.Co. LLC


UNITED ARAB EMIRATES

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin
USP

24

Global Pharma.Co. LLC


UNITED ARAB EMIRATES

Ranitidine Hydrochloride
USP

1,426 TAN 06,055 J01C GLO

Shelf life
month

Gloclav,Tablet

Gloclav,Tablet

Guilin Pharmaceuticals Ltd - CHINA


Artesun,Powder for Injection

Artesunate IP/INH

60 mg

36

Guilin Pharmaceuticals Ltd


CHINA

Pyrimethamine USP
Sulfadoxine USP
Artesunate IP

25 mg
200 mg
50 mg

24

Guilin Pharmaceuticals Ltd


CHINA

Artescope,Tablet

Gulf Pharmaceutical Industries (JULPHAR) - UNITED ARAB EMIRATES


3V,Tablet

Pyridoxine Hydrochloride
200 mg
BP
200 mcg
Cyanocobalamin Ph Eur
Thiamine Monohydrate USP 100 mg

Page 225 of 584

24

Gulf Pharmaceutical
Industries (JULPHAR)
UNITED ARAB EMIRATES

Human Medicinal Products


S/No:

Registration Number

1,431 TAN 10, 015 V07A GUL

1,432 TZ11H005

1,433 TZ11H006

1,434 TZ11H173

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,435 TAN 00,212 D07C AUR

Ginseng BP

40 mg

36

Paracetamol BP

250 mg

60

Paracetamol BP

250 mg

60

1.16 g

36

5.75 %w/w
0.65 %w/w

36

1,436 TAN 00,1388 M01A ELY

400 mg
50 mg
200 mg

24

Gulf Pharmaceutical
Industries (JULPHAR)
UNITED ARAB EMIRATES

Adol,Suppositories
Gulf Pharmaceutical
Industries (JULPHAR)
UNITED ARAB EMIRATES

Nefloc Cremagel,Gel
Gulf Pharmaceutical
Industries (JULPHAR)
UNITED ARAB EMIRATES

Hastand E.M.P LTD - INDIA


Betacort N,Cream
Aurochem Pharmaceuticals
(I) Pvt. Ltd
INDIA

HB Wordwide Ltd - TANZANIA


Dawa Tatu,Tablet

Acetylsalicylic Acid BP
Caffeine Anhydrous BP
Paracetamol BP

Registrant

Gulf Pharmaceutical
Industries (JULPHAR)
UNITED ARAB EMIRATES

Adol,Suppositories

Neomycin Sulphate BP
Betamethasone
Dipropionate USP

Registrant

Manufacturer

Ginsavit,Capsules

Diclofenac
Diethylammonium
equivalent to Diclofenac
Sodium BP

Registrant

Shelf life
month

Helm Pharmaceuticals GmbH - GERMANY


Page 226 of 584

Elys Chemical industries


Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

1,437 TAN 05,498 G03A HEL

Product Name
Pack and Pack size

Ingredient(s) and Strength

Petogen-fresenius,Injectable
Solution

1,439 TAN 05,573 J05A HET

1,440 TAN 05,572 J05A HET

1,441 TAN 05,571 J05A HET

1,442 TAN 05,568 J05A HET

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

36

150 mg/ml

36

Nevirapine IH

200 mg

24

Hetero Drugs Ltd.


INDIA

Stavudine IH

30 mg

24

Hetero Drugs Ltd.


INDIA

Indinavir Sulphate IH

400 mg

24

Hetero Drugs Ltd.


INDIA

Zidovudine IH

300 mg

24

Hetero Drugs Ltd.


INDIA

Petogen-fresenius,Injectable
Solution

Medroxyprogesterone
Acetate Ph Eur

Registrant

Manufacturer

150 mg/ml

Medroxyprogesterone
Acetate Ph Eur

1,438 TAN 05,498 G03A HEL

Shelf life
month

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Hetero Drugs Ltd. - INDIA


Nevivir,Tablet

Stag,Capsules

Indivir,Capsules

Zido H,Tablet

Page 227 of 584

Human Medicinal Products


S/No:

Registration Number

1,443 TAN 05,567 J05A HET

1,444 TAN 05,566 J05A HET

1,445 TAN 05,565 J05A HET

1,446 TAN 05,574 J05A HET

1,447 TAN 05,564 J05A HET

1,448 TAN 08,135 J05A HET

Registrant

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Estiva,Capsules

Efavirenz IH

200 mg

24

Hetero Drugs Ltd.


INDIA

Efavirenz IH

600 mg

24

Hetero Drugs Ltd.


INDIA

Lamivudine IH
Nevirapine IH
Stavudine IH

150 mg
200 mg
40 mg

24

Hetero Drugs Ltd.


INDIA

Lamivudine BP

150 mg

24

Hetero Drugs Ltd.


INDIA

Lamivudine IH
Nevirapine IH
Stavudine IH

150 mg
20 mg
30 mg

24

Hetero Drugs Ltd.


INDIA

Stavudine IH
Lamivudine USP

30 mg
150 mg

24

Hetero Drugs Ltd.


INDIA

Estiva,Tablet

Nevilast,Tablet

Heptavir,Tablet

Nevilast,Tablet

Lamistar-30,Tablet

Hilton Pharma (Pvt) Ltd. - PAKISTAN

Page 228 of 584

Human Medicinal Products


S/No:

Registration Number

1,449 TAN 10,015, V07A HIL

1,450 TAN 05,499 B02A HIL

1,451 TAN 05,500 B02A HIL

1,452 TAN 06,056 B03A HIL

1,453 TAN 06,057 B03A HIL

1,454 TAN 06,151 B03A HIL

1,455 TAN 09,146 N06A HIL

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Hilac,Solution

Lactulose BP

68 %w/v

35

Hilton Pharma (PVT) Ltd.


PAKISTAN

Tranexamic Acid JP

250 mg

24

Hilton Pharma (PVT) Ltd.


PAKISTAN

Tranexamic Acid IH

500 mg

48

Hilton Pharma (PVT) Ltd.


PAKISTAN

Iron (III) Hydroxide


Polymatose Complex IH
Folic Acid IH

333.97 mg

24

Hilton Pharma (PVT) Ltd.


PAKISTAN

Iron (III) Hydroxide


Polymatose Complex IH

50 mg/5ml

24

Hilton Pharma (PVT) Ltd.


PAKISTAN

Iron (III) Hydroxide


Polymatose Complex IH

100 mg

36

Hilton Pharma (PVT) Ltd.


PAKISTAN

Fluoxetine Hydrochloride
USP

20 mg

24

Hilton Pharma (PVT) Ltd.


PAKISTAN

Trexamin,Capsules

Trexamin,Capsules

Ferosoft-FA,Tablet

0.3675 mg

Ferosoft,Syrup

Ferosoft,Tablet

Flux,Tablet

Page 229 of 584

Human Medicinal Products


S/No:

Registration Number

1,456 TAN 06,406 R03A HIL

1,457 TAN 06,404 R03A HIL

1,458 TAN 06,402 A02C HIL

1,459 TAN 06,405 A02C HIL

1,460 TAN 06,403 A02C HIL

Registrant
1,461 TAN 00,4111 J01H HIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Myteka,Tablet

Montelukast Sodium IH

10 mg

24

Hilton Pharma (PVT) Ltd.


PAKISTAN

Montelukast Sodium IH

5 mg

24

Hilton Pharma (PVT) Ltd.


PAKISTAN

Gabapentin IH

100 mg

36

Hilton Pharma (PVT) Ltd.


PAKISTAN

Gabapentin IH

400 mg

36

Hilton Pharma (PVT) Ltd.


PAKISTAN

Gabapentin IH

300 mg

36

Hilton Pharma (PVT) Ltd.


PAKISTAN

36

Hindustan Antibiotics Ltd.


INDIA

Myteka,Tablet

Neogab,Capsules

Neogab,Capsules

Neogab,Capsules

Hindustan Antibiotics Ltd. - INDIA


Sodicillin,Powder for Injection

Benzyl penicillin Sodium BP 5000000 IU

Page 230 of 584

Human Medicinal Products


S/No:

Registration Number

1,462 TAN 06,299 J01H HIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,463 TAN 00,4555 J05A HOE

1,464 TAN 00,4600 A01A HOE

1,465 TAN 00,2563 D07C HOE

1,466 TAN 00,4113 D06A HOE

1,467 TAN 00,4470 J02A HOE

Manufacturer

Procillin Forte,Powder

Benzyl penicillin Sodium BP 1000000 IU


3000000 IU
Procaine Penicillin BP

Registrant

Shelf life
month

48

Hindustan Antibiotics Ltd.


INDIA

Hoe Pharmaceuticals Sdn Bhd - MALAYSIA


Declovir,Cream

Acyclovir BP
Tea Tree Oil IH

5 %w/w
5 mg

36

Triamcinolone Acetonide
USP

0.1 %w/w

36

Sodium Fusidate BP
Betamethasone
Dipropionate USP

2 %w/w
0.064 %w/w

36

Fusidic Acid BP

2 %w/w

36

Clotrimazole BP

1 %w/w

36

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

Orrepaste,Paste
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Fobancort,Ointment
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Foban,Cream
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Cancazole,Cream

Page 231 of 584

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

Human Medicinal Products


S/No:

Registration Number

1,468 TAN 05,026 J01F HOE

1,469 TAN 05,027 J01F HOE

1,470 TAN 00,2564 D01A HOE

1,471 TAN 00,2565 D07B HOE

1,472 TAN 00,2566 D07X HOE

1,473 TAN 00,2664 D06A HOE

1,474 TAN 00,2570 D07A HOE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

C-Mycin,Lotion

Clindamycin Phosphate
USP

1.2 %w/v

36

Clindamycin Phosphate
USP

1.2 %w/w

36

Ketoconazole USP

2 %w/v

36

Betamethasone
Dipropionate USP
Salicylic Acid USP

0.064 %w/w

36

Clotrimazole USP
Hydrocortisone USP

1 %w/w
1 %w/w

36

Sodium Fusidate BP

2 %w/w

36

0.064 %w/w

36

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

C-Mycin,Gel
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Dezor,Shampoo
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Beprosalic,Ointment

3 %w/w

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

Candacort,Cream
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Foban,Ointment
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Beprosone,Ointment

Betamethasone
Dipropionate USP

Page 232 of 584

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

Human Medicinal Products


S/No:

Registration Number

1,475 TAN 00,2567 D07A HOE

1,476 TAN 00,2568 D07A HOE

1,477 TAN 00,2572 D07A HOE

1,478 TAN 00,2569 D01A HOE

1,479 TAN 00,2571 D07C HOE

1,480 TAN 05,026 J01F HOE

1,481 TAN 05,027 J01F HOE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Beprosone,Cream

Betamethasone
Dipropionate USP

0.064 %w/w

36

Clobetasol Propionate BP

0.0568 %w/w

36

Clobetasol Propionate BP

0.0568 %w/w

36

Ketoconazole USP

2 %w/w

36

Fusidic Acid BP
Betamethasone
Dipropionate USP

2 %w/w
0.064 %w/w

36

Clindamycin Phosphate
USP

1.2 %w/v

36

Clindamycin Phosphate
USP

12 %w/w

36

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

Cloderm,Ointment
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Cloderm,Cream
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Dezor,Cream
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Fobancort,Cream
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

C-Mycin,Lotion
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

C-Mycin,Gel

Page 233 of 584

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

Human Medicinal Products


S/No:

Registration Number

1,482 TAN 00,2564 D01A HOE

1,483 TAN 00,2564 D01A HOE

1,484 TAN 00,2566 D07X HOE

1,485 TAN 00,2566 D07X HOE

Registrant
1,486 TAN 09,282 D06A HOE

1,487 TAN 09,281 D07A HOE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Dezor,Shampoo

Ketoconazole USP

2 %w/v

36

Ketoconazole USP

2 %w/v

36

Clotrimazole USP
Hydrocortisone USP

1 %w/w
1 %w/w

36

Clotrimazole USP
Hydrocortisone USP

1 %w/w
1 %w/w

36

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

Dezor,Shampoo
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Candacort,Cream
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Candacort,Cream
Hoe Pharmaceuticals Sdn
Bhd
MALAYSIA

Hoe Pharmaceuticals SDN.BHD - MALAYSIA


Muprin,Ointment

Mupirocin USP

2 %w/w

36

Clobetasone Butyrate BP

0.05 %w/w

36

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

U- Closone,Cream

Page 234 of 584

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

Human Medicinal Products


S/No:

Registration Number

1,488 TAN 10, 016 P03A HOE

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,489 TAN 09,147 J01C HOV

1,491 TAN 05,714 M01A HOV

1,492 TAN 05,562 J01D HOV

1,493 TAN 05,561 J01H HOV

Hoe Pharmaceuticals Sdn


Bhd
MALAYSIA

5 %w/v

36

125 mg/5ml

24

Hovid Bhd
MALAYSIA

Hovid Bhd - MALAYSIA


Clamovid,Granules for
suspension

Amoxicillin Trihydrate Ph
Eur
Potassium Clavunate
Equivalent to Clavulanic
Acid Ph Eur

1,490 TAN 05,563 J01D HOV

Manufacturer

A Scabs,Lotion

Permethrin IH

Registrant

Shelf life
month

31.25 mg/5ml

Celexin 500,Capsules

Cefalexin BP

500 mg

36

Hovid Bhd
MALAYSIA

Diclofenac Sodium BP

50 mg

36

Hovid Bhd
MALAYSIA

Cefalexin BP

250 mg

36

Hovid Bhd
MALAYSIA

36

Hovid Bhd
MALAYSIA

Clofenac-50,Tablet

Celexin 250,Tablet

Amoxigran,Powder

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

Page 235 of 584

Human Medicinal Products


S/No:

Registration Number

1,494 TAN 05,713 J01A HOV

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,496 TAN 06,152 J05A HOV

1,497 TAN 06,301 A10B HOV

1,498 TAN 06,300 M01A HOV

100 mg

36

Hovid Bhd
MALAYSIA

500 mg
Amoxycillin Trihydrate Ph
Eur
Potassium Clavulanate eq to 125 mg
Clavulanic Acid Ph Eur

24

Bilim Pharmaceticals A.S,


TURKEY

Acyclovir BP

200 mg

36

Hovid Bhd
MALAYSIA

Metformin Hydrochloride BP 500 mg

36

Hovid Bhd
MALAYSIA

36

Hovid Bhd
MALAYSIA

36

Hovid Bhd
MALAYSIA

Clamovid 625,Tablet

Virest,Tablet

Diabetmin,Tablet

Flucor Day,Capsules

Paracetamol BP
Dextromethorphan
Hydrochloride BP
Pseudoephedrine
Hydrobromide BP
1,499 TAN 06,407 J01H HOV

Manufacturer

Doxycap,Capsules

Doxycycline Hydrochloride
EP

1,495 TAN 05,560 J01C HOV

Shelf life
month

250 mg
10 mg
30 mg

Amoxicap,Capsules

Amoxicillin Trihydrate eq to 250 mg


Amoxicillin BP

Page 236 of 584

Human Medicinal Products


S/No:

Registration Number

1,500 TAN 07,044 J01F HOV

1,501 TAN 07,043 D04A HOV

1,502 TAN 07,183 A02B HOV

1,503 TAN 07,309 V07A HOV

1,504 TAN 07,310 J02A HOV

1,505 TAN 10, 066 M01A

1,506 TZ10H125

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Erotab,Tablet

Erythromycin Stearate eq to 250 mg


Erythromycin BP

36

Hovid Bhd
MALAYSIA

Loratadine IH

10 mg

36

Hovid Bhd
MALAYSIA

Omeprazole IH

20 mg

24

Hovid Bhd
MALAYSIA

Thiamine Mononitrate BP
Cyanocobalamin BP
Pyridoxine Hydrochloride
Ascorbic Acid BP

242 mg
1 mg
250 mg

36

Hovid Bhd
MALAYSIA

Ketoconazole BP

200 mg

24

Hovid Bhd
MALAYSIA

Diclofenac Sodium BP

100 mg

24

Hovid Bhd
MALAYSIA

Sulfamethoxazole BP
Trimethoprim BP

800 mg
160 mg

36

Hovid Bhd
MALAYSIA

Loratyn,Tablet

Omezole,Capsules

Neurovit Forte,Tablet

Ketovid,Tablet

Clofenac SR,Tablet

Suprim,Tablets

Page 237 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
1,507 TAN 06,058 D01A IND

1,508 TAN 06,060 D01A IND

1,509 TAN 06,061 D01A IND

1,510 TAN 06,059 D06A IND

1,511 TAN 07,312 J03C IND

1,512 TAN 07,481 D01B IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Indi Pharma Pvt Ltd. - INDIA


Persol Forte,Cream

Precipated Sulphur IP
Anhydrous Benzoyl
Peroxide BP

5 %w/w
10 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Benzoyl Peroxide BP

5 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Hydrous Benzoyl Peroxide


BP

2.5 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Sodium Fusidate IP

20 mg

24

Indi Pharma Pvt Ltd.


INDIA

Allantoin IH
Aloe Extract USP
Silver Sulphadiazine USP
Chlorhexidine Gluconate
USP

15 %w/w
0.2 %w/w
1.033 %w/w
1.273 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Terbinafine Hydrochloride
IH

1%

24

Indi Pharma Pvt Ltd.


INDIA

Persol 5.0 gel,Gel

Persol,Gel

Fusiderm,Ointment

Dermogard,Cream

Terbinyl,Cream

Page 238 of 584

Human Medicinal Products


S/No:

Registration Number

1,513 TAN 07,311 J01F IND

1,514 TAN 06,058 D01A IND

1,515 TAN 06,058 D01A IND

1,516 TAN 06,060 D01A IND

1,517 TAN 06,060 D01A IND

1,518 TAN 06,061 D01A IND

1,519 TAN 06,061 D01A IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Clincin,Gel

Clindamycin Hydrochloride 1 %w/v


USP

48

Indi Pharma Pvt Ltd.


INDIA

Precipated Sulphur IP
Anhydrous Benzoyl
Peroxide BP

5 %w/w
10 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Precipated Sulphur IP
Anhydrous Benzoyl
Peroxide BP

5 %w/w
10 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Benzoyl Peroxide BP

5 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Benzoyl Peroxide BP

5 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Hydrous Benzoyl Peroxide


BP

2.5 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Hydrous Benzoyl Peroxide


BP

2.5 %w/w

24

Indi Pharma Pvt Ltd.


INDIA

Persol Forte,Cream

Persol Forte,Cream

Persol 5.0 gel,Gel

Persol 5.0 gel,Gel

Persol,Gel

Persol,Gel

Page 239 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

1,520 TAN 06,059 D06A IND

Fusiderm,Ointment

Ingredient(s) and Strength

24

Indi Pharma Pvt Ltd.


INDIA

20 mg

24

Indi Pharma Pvt Ltd.


INDIA

Paracetamol BP
Dicyclomine Hydrochloride
BP

500 mg
20 mg

36

Indoco Remedies Ltd.


INDIA

Folic Acid BP
Iron (III) Hydroxide
Polymatose Complex IH

350 mcg
100 mg

24

Indoco Remedies Ltd.


INDIA

Atenolol BP

50 mg

36

Indoco Remedies Ltd


INDIA

Diclofenac Sodium BP

50 mg

36

Indoco Remedies Ltd


INDIA

Fusiderm,Ointment

Sodium Fusidate IP

Registrant
1,522 TAN 00,2347 A03D IND

1,523 TAN 00,4291 B03A IND

1,524 TAN 05,028 C01K IND

1,525 TAN 00,4601 M01A IND

Manufacturer

20 mg

Sodium Fusidate IP

1,521 TAN 06,059 D06A IND

Shelf life
month

Indoco Remedies Ltd. - INDIA


Cyclopam,Tablet

Fevorit,Tablet

Altol-50,Tablet

Osteoflam,Tablet

Page 240 of 584

Human Medicinal Products


S/No:

Registration Number

1,526 TAN 05,501 J01K IND

1,527 TAN 00,4556 D01A IND

1,528 TAN 05,647 M01A IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

Ciprofloxacin Hydrochloride 500 mg


USP

36

Indoco Remedies Ltd


INDIA

Clotrimazole USP

1%

36

Indoco Remedies Ltd.


INDIA

25 mg/ml

24

Indoco Remedies Ltd.


INDIA

125 mg/ml

24

Indoco Remedies Ltd.


INDIA

Albendazole USP

200 mg/ml

36

Indoco Remedies Ltd.


INDIA

Albendazole USP

400 mg

36

Indoco Remedies Ltd.


INDIA

Ciprofloxacin USP

500 mg

36

Indoco Remedies Ltd.


INDIA

Clob,Cream

Osteoflam,Injectable Solution

Hemsyl,Injectable Solution

Etamsylate BP

1,530 TAN 07,315 P02X IND

1,531 TAN 07,314 P02X IND

1,532 TAN 07,313 J01K IND

Manufacturer

Ciprind-500,Tablet

Diclofenac Sodium BP

1,529 TAN 07,046 B02B IND

Shelf life
month

Albendazole,Suspension

Albendazole,Tablet

Ciprind-500,Tablet

Page 241 of 584

Human Medicinal Products


S/No:

Registration Number

1,533 TAN 07,484 A03D IND

1,534 TAN 07,483 J01F IND

1,535 TAN 07,482 S01C IND

1,536 TAN 00,2457 D01A IND

1,537 TAN 00,2344 A04A IND

1,538 TAN 00,2349 M01A IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Colirem,Tablet
500 mg
Paracetamol BP
Dicycloverine Hydrochloride 20 mg
BP

48

Indoco Remedies Ltd


INDIA

Erythromycin Stearate eq to 250 mg


Erythromycin BP

24

Indoco Remedies Ltd.


INDIA

Clotrimazole BP
Betamethasone
Dipropionate BP
Gentamycin Sulphate
equivalent to Gemtamicin
BP

1 %w/w
0.025 %w/w

36

Indoco Remedies Ltd.


INDIA

Beclomethasone
Dipropionate BP
Clotrimazole BP

0.025 %w/w

36

Indoco Remedies Ltd.


INDIA

Pyridoxine Hydrochloride
10 mg
BP
Doxylamine Succinate USP 10 mg

24

Indoco Remedies Ltd.


INDIA

Diclofenac Sodium BP
Paracetamol BP
Chlorzoxazone USP

24

Indoco Remedies Ltd.


INDIA

Indo 250,Tablet

Cloben-G,Cream

0.1 %w/w

Cloben,Cream

1 %w/w

Nosic,Tablet

Flamar-mx,Tablet

Page 242 of 584

50 mg
325 mg
250 mg

Human Medicinal Products


S/No:

Registration Number

1,539 TAN 00,2349 M01A IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

325 mg
50 mg
250 mg

36

Indoco Remedies Ltd.


INDIA

10 mg/ml

36

Indoco Remedies Ltd


INDIA

Fexofenadine Hydrochloride 180 mg


IH

24

Ind-Swift Ltd
INDIA

Nitazoxanide BP

200 mg

18

Ind-Swift Ltd
INDIA

Clarithromycin USP

500 mg

24

Ind-Swift Ltd
INDIA

Atorvastatin Calcium IH

20 mg

24

Ind-Swift Ltd
INDIA

Cyclopam,Injectable Solution

Dicyclomine Hydrochloride
USP

Registrant
1,541 TAN 09,149 R06A IND

1,542 TAN 07,317 A07F IND

1,543 TAN 10,022 J01F IND

1,544 TAN 10,021 B04A IND

Manufacturer

Flamar MX,Tablet

Paracetamol BP
Diclofenac Potassium BP
Chlorzoxazone USP
1,540 TAN 08,060 A03D IND

Shelf life
month

Ind-Swift Ltd - INDIA


Fexidine,Tablet

Netazox,Tablet

Clarie - OD,Tablet

Atstat,Tablet

Page 243 of 584

Human Medicinal Products


S/No:

Registration Number

1,545 TAN 10, 018 N05A IND

1,546 TAN 10,017 N05A IND

1,547 TAN 10, 019 B04A IND

1,548 TAN 10, 020 R06A IND

1,549 TZ11H175

Registrant
1,550 TAN 09,150 A04A IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Lopram,Tablet
Indi - Swift Laboratories
Ltd.
INDIA

Citalopram Hydrobromide
(eq to Citalopram) IH

10 mg

24

Citalopram Hydrobromide
(eq to Citalopram) IH

20 mg

24

Atorvastatin Calcium IH

10 mg

24

Fexofenadine Hydrochloride 60 mg
IH

24

Metformin Hydrochloride BP 500 mg

36

Ind-Swift Ltd
INDIA

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Lopram,Tablet
Ind-Swift Ltd
INDIA

Atstat,Tablet
Indi - Swift Laboratories
Ltd.
INDIA

Fexidine Kid Tab,Tablet


Indi - Swift Laboratories
Ltd.
INDIA

Metswift,Tablet

Indus Pharma (Pvt) Ltd. - PAKISTAN


Metoclon,Injectable Solution

Metoclopramide
Hydrochloride BP

Page 244 of 584

10 mg/2ml

Human Medicinal Products


S/No:

Registration Number

1,551 TAN 09,150 A04A IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

10 mg/2ml

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

75 mg/3ml

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

250 mg/5ml

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

1g

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

500 mg

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Cephradine Monohydrate
eq to Cephradine USP

250 mg

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Mecobalamine IH

500 mcg

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Diclo,Injectable Solution

Diclofenac Sodium BP

1,553 TAN 07,321 J01D IND

Vericef,Powder for Suspension

Cephradine Monohydrate
eq to Cephradine USP

1,554 TAN 07,326 J01D IND

Vericef,Powder for Injection

Cephradine Monohydrate
eq to Cephradine USP

1,555 TAN 07,320 J01D IND

Vericef,Powder for Injection

Cephradine Monohydrate
eq to Cephradine USP

1,556 TAN 07,322 J01D IND

1,557 TAN 07,327 A11H IND

Manufacturer

Metoclon,Injectable Solution

Metoclopramide
Hydrochloride BP

1,552 TAN 07,047 M01A IND

Shelf life
month

Vericef,Powder for Injection

Incobal,Tablet

Page 245 of 584

Human Medicinal Products


S/No:

Registration Number

1,558 TAN 07,325 N04B IND

1,559 TAN 07,319 J01D IND

1,560 TAN 07,318 J01D IND

1,561 TAN 07,324 J01D IND

1,562 TAN 07,486 A11H IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

Midazolam BP

5 mg/ml

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Cephradine Monohydrate
eq to Cephradine USP

500 mg

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Ceftriaxone Sodium eq to
Ceftriaxone USP

250 mg

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Ceftriaxone Sodium eq to
Ceftriaxone USP

500 mg

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

500 mcg/ml

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

1g

36

Indus Pharma (Pvt) Ltd.


PAKISTAN

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Vericef,Capsules

Maxef,Injection

Maxef,Injection

Incobal,Injectable Solution

Maxef,Powder for Injection

Ceftriaxone Disodium USP

1,564 TAN 07,485 A02B IND

Manufacturer

Milam,Injection

Mecobalamine IH

1,563 TAN 07,487 J01D IND

Shelf life
month

Anzol,Injectable Solution

Ranitidine Hydrochloride
50 mg/2ml
equivalent to Ranitidine BP

Page 246 of 584

Human Medicinal Products


S/No:

Registration Number

1,565 TAN 08,100 N02A IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

0.5 mg

36

Inga Laboratories Pvt Ltd.


INDIA

75 mg/3ml

36

Intas Pharmaceuticals Ltd


INDIA

300 mg/ml

36

Intas Pharmaceuticals Ltd


INDIA

30 mg/ml

Ketasol,Injectable Solution

Ketamine Hydrochloride BP 250 mg/5ml

1,567 TAN 08,137 N01A IND

Ketasol,Injectable Solution

Ketamine Hydrochloride BP 100 mg/2ml

Registrant
1,568 TAN 07,048 ING

Inga Laboratories Pvt Ltd. - INDIA


Goutnil,Tablet

Colchicine BP

Registrant
1,569 TAN 00,484 M01A INT

Intas Pharmaceuticals Ltd - INDIA


Dicloflame,Injectable Solution

Diclofenac Sodium BP

1,570 TAN 00,485 P01B INT

Manufacturer

Pentazogon,Injection

Pentazocine BP

1,566 TAN 08,136 N01A IND

Shelf life
month

Kwinil,Injectable Solution

Quinine Dihydrochloride
BP

Page 247 of 584

Human Medicinal Products


S/No:

Registration Number

1,571 TAN 00,4557 A10B INT

1,572 TAN 00,1434 A02B INT

1,573 TAN 00,726 J01K INT

1,574 TAN 00,731 C01E INT

1,575 TAN 09,152 A10B INT

1,576 TAN 00,4292 B04A INT

1,577 TAN 00,4363 B01A INT

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Glitas 30,Tablet

Pioglitazone Hydrocloride
equivalent Pioglitazone IH

30 mg

24

Intas Pharmaceutical Ltd.


INDIA

Lansoprazole USP

30 mg

24

Intas Pharmaceuticals Ltd


INDIA

Gentamicin Sulphate
80 mg/2ml
equivalent to Gentamicin BP

36

Intas Pharmaceuticals Ltd.


INDIA

Losartan Potassium IH

50 mg

24

Intas Pharmaceuticals Ltd.


INDIA

Glimepiride USP

2.0 mg

24

Intas Pharmaceutical Ltd.


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

24

Clopidogrel Bisulfate IH

75 mg

24

Lan,Capsules

Intagenta,Injectable Solution

Losartas,Tablet

Zoryl-2,Tablet

Lipicure,Tablet
Intas Biopharmaceuticals
Ltd.
INDIA

Clavix,Tablet

Page 248 of 584

Intas Pharmaceuticals Ltd.


INDIA

Human Medicinal Products


S/No:

Registration Number

1,578 TAN 00,4472 C01L INT

Product Name
Pack and Pack size

Ingredient(s) and Strength

50 mg
12.5 mg

36

Intas Pharmaceuticals Ltd.


INDIA

75 mg/3ml

36

Intas Pharmaceuticals Ltd


INDIA

Quinine Dihydrochloride
BP

300 mg/ml

36

Intas Pharmaceuticals Ltd


INDIA

Losartan Potasium IH

25 mg

24

Intas Pharmaceuticals Ltd


INDIA

Amlodipine Besylate USP

5 mg

36

Intas Pharmaceuticals Ltd.


INDIA

Aceclofenac BP

100 mg

24

Intas Pharmaceutical Ltd.


INDIA

Drotaverine Hydrochloride
IH

40 mg

24

Intas Pharmaceutical Ltd.


INDIA

Dicloflame,Injectable Solution

Diclofenac Sodium BP

1,580 TAN 00,485 P01B INT

1,581 TAN 05,179 C01E INT

1,582 TAN 00,725 C01K INT

1,583 TAN 06,153 M01A INT

1,584 TAN 07,049 A03A INT

Manufacturer

Losartas HT,Tablet

Losartan Potassium USP


Hydrochlorthiazide USP

1,579 TAN 00,484 M01A INT

Shelf life
month

Kwinil,Injectable Solution

Losartas,Tablet

Amtas,Tablet

Hifenac,Tablet

Doverin-40,Tablet

Page 249 of 584

Human Medicinal Products


S/No:

Registration Number

1,585 TAN 00,1609 J01A INT

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,587 TAN 07,328 A02B INT

1,588 TAN 00,2154 A02B INT

100 mg

36

Intas Pharmaceuticals Ltd


INDIA

Praziquantel BP

600 mg

36

Intas Pharmaceuticals Ltd


INDIA

Omeprazole USP

20 mg

24

Intas Pharmaceuticals Ltd.


INDIA

500 mg
30 mg
250 mg

24

Intas Pharmaceuticals Ltd.


INDIA

Fexofenadine Hydrochloride 180 mg


IH

36

Intas Pharmaceuticals Ltd


INDIA

Fexofenadine Hydrochloride 180 mg


IH

36

Intas Pharmaceuticals Ltd


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

24

Inta Praziquantel,Tablet

Omey-20,Capsules

Heligo,Capsule & tablets

Tinidazole BP
Lansoprazole IH
Clarithromycin USP
1,589 TAN 00,4294 D04A INT

1,590 TAN 00,4294 D04A INT

1,591 TAN 00,4292 B04A INT

Manufacturer

Doxytas,Capsules

Doxycycline Hydrochloride
BP

1,586 TAN 00,1614 P02A INT

Shelf life
month

Allegix,Tablet

Allegix,Tablet

Lipicure,Tablet

Page 250 of 584

20 mg

Intas Biopharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,592 TAN 08,139 A11E INT

1,593 TAN 08,138 C01K INT

1,594 TAN 00,729 D01B INT

1,595 TAN 00,734 P01B INT

1,596 TAN 09,283 A10B INT

1,597 TAN 10, 023 M01A INT

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Vitamin B Complex,Injection
24

Intas Pharmaceuticals Ltd.


INDIA

5 mg
50 mg

24

Intas Pharmaceuticals
INDIA

Ketoconazole USP

200 mg

36

Intas Pharmaceuticals Ltd


INDIA

Pyrimethamine USP
Sulfadoxine USP

25 mg
500 mg

36

Intas Pharmaceutical Ltd.


INDIA

Glimepiride BP

1 mg

24

Intas Pharmaceutical Ltd.


INDIA

Aceclofenac BP

100 mg

24

Intas Pharmaceuticals
INDIA

Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Riboflavine Sodium
Phosphate USP
Thiamine Mononitrate USP
Panthenol USP

20 mg/ml
2 mg/ml

Amlodipine Besylate BP
Atenolol BP

2 mg/ml
5 mg/ml
3 mg/ml

Amtas-AT,Tablet

Kezole,Tablet

Malostat,Tablet

Zoryl -1,Tablet

Hifenac,Tablet

Page 251 of 584

Human Medicinal Products


S/No:

Registration Number

1,598 TAN 10,024 A02B INT

1,599 TAN 05,179 C01E INT

1,600 TAN 05,179 C01E INT

1,601 TAN 00,725 C01K INT

1,602 TAN 00,4294 D04A INT

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,603 TAN 06,071 J03B IDA

Manufacturer

Rabtas,Tablet
Intas Biopharmaceuticals
Ltd.
INDIA

Rabeprazole Sodium IH

20 mg

24

Losartan Potasium IH

25 mg

24

Intas Pharmaceuticals Ltd


INDIA

Losartan Potasium IH

25 mg

24

Intas Pharmaceuticals Ltd


INDIA

Amlodipine Besylate BP

7.128 mg

36

Intas Pharmaceuticals Ltd.


INDIA

36

Intas Pharmaceuticals Ltd


INDIA

Losartas,Tablet

Losartas,Tablet

Amtas,Tablet

Allegix,Tablet

Fexofenadine Hydrochloride 180 mg


IH

Registrant

Shelf life
month

International Dispensary Association. - NETHERLANDS


Co-trimoxazole,Tablet

Sulfamethoxazole BP
Trimethoprim BP

Page 252 of 584

100 mg
20 mg

36

Micro Labs Ltd.


INDIA

Human Medicinal Products


S/No:

Registration Number

1,604 TAN 09,153 J01A IDA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Tetracycline,Ophthalmic
Ointment

Tetracycline USP

1,605 TAN 00,1835 D08A IDA

10 mg

36

FDC Ltd.
INDIA

10 mg/ml

48

Purna Pharmaceuticals
BELGIUM

24

Laboratoire Renaudin
FRANCE

400 mg
80 mg

48

Micro Labs Ltd.


INDIA

250 mg

36

Micro Labs Ltd.


INDIA

36

Cipla Ltd.
INDIA

Epinephrine,Injection

Adrenaline Tartrate Ph Eur 1 mg/ml

1,607 TAN 05,073 J03B IDA

Co-trimoxazole,Tablet

Sulfamethoxazole BP
Trimethoprim BP

1,608 TAN 05,074 P01A IDA

Metronidazole,Tablet

Metronidazole BP

1,609 TAN 05,662 R03A IDA

Salbutamol,Inhaler

Salbutamol Sulphate
0.1 mg/dose
equivalent to Salbutamol BP

1,610 TAN 05,774 D01A IDA

Manufacturer

Povidone Iodine,Solution

Povidone Iodine EP

1,606 TAN 00,2159 C01C IDA

Shelf life
month

Nystatin,Suspension

Nystatin BP

Page 253 of 584

100000 Armour Units


IU/ml

24

Cipla Ltd at Mediorals


Laboratories PVT Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,611 TAN 05,775 H02A IDA

1,612 TAN 06,069 A02C IDA

1,613 TAN 06,072 J01H IDA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Dexamethasone Sodium
Phosphate USP

5 mg/ml

24

Gland Pharma Ltd.


INDIA

Albendazole USP

200 mg

36

Micro Labs Ltd.


INDIA

250 mg

36

50 mg

36

Albendazole,Tablet

Amoxicillin,Capsules

Gentamycin,Injectable
Solution

Gentamycin Sulphate Ph
Eur

1,617 TAN 06,162 J01H IDA

Micro Labs Ltd.


INDIA

Ciprofloxacin,Tablet

Ciprofloxacin Hydrochloride 500 mg


USP

1,616 TAN 06,161 J01K IDA

Brown & Burk


Pharmaceuticals Ltd.
INDIA

Hydrochlorothiazide,Tablet

Hydrochlorthiazide BP

1,615 TAN 06,160 J01K IDA

Manufacturer

Dexamethasone,Injection

Amoxicillin Sodium BP

1,614 TAN 06,070 C01K IDA

Shelf life
month

Phenoxymethylpenicillin,Tabl
et

Phenoxymethyl Penicillin
Potassium BP

Page 254 of 584

24

Brown & Burk


Pharmaceuticals Ltd.
INDIA

80 mg/ml

36

Gland Pharma Ltd.


INDIA

250 mg

36

Medreich Sterilab Ltd.


INDIA

Human Medicinal Products


S/No:

Registration Number

1,618 D543

Product Name
Pack and Pack size

Ingredient(s) and Strength

36

1000 mg

36

300 mg/ml

36

Gland Pharma Ltd.


INDIA

20 g
3.5 g
2.9 g
1.5 g

36

FDC Ltd.
INDIA

1 mg/ml

36

Grand Pharma Ltd.


INDIA

Ampicillin Sodium BP

500 mg

36

Sulfadoxine USP
Pyrimethamine USP

500 mg
25 mg

48

Ampicilin,Powder for
Injection

Quinine
Dihydrochloride,Injectable
Quinine Dihydrochloride
Solution

BP

1,621 TAN 06,159 A07C IDA

Atropine,Injectable Solution

Atropine Sulphate BP

1,623 TAN 06,158 J01H IDA

1,624 TAN 06,168 P01B IDA

Harbin Pharmaceutical
Group Co.Ltd.
CHINA

Oral Rehydration Salt,Powder

Anhydrous Glucose BP
Sodium Chloride BP
Sodium Citrate BP
Potassium Chloride BP
1,622 TAN 06,167 A03B IDA

Micro Labs Ltd.


INDIA

200 mg

Ampicillin Sodium
equivalent to Ampicillin BP

1,620 TAN 06,165 P01B IDA

Manufacturer

Ibuprofen,Tablet

Ibuprofen BP

1,619 TAN 06,176 J01H IDA

Shelf life
month

Ampicilin,Injectable Solution

Pyrimethamine +
Sulfadoxine,Tablet

Page 255 of 584

Harbin Pharmaceutical
Group Co.Ltd.
CHINA

Brown & Burk


Pharmaceuticals Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

1,625 TAN 06,164 N06A IDA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Neostigmine,Injectable
Solution

1,627 TAN 06,171 D01A IDA

1,628 TAN 06,172 D01A IDA

1,629 TAN 06,173 J01A IDA

24

Farmchem Ltd.
TANZANIA

Digoxin Ph Eur

0.5 mg/ml

36

Gland Pharma Ltd.


INDIA

Nystatin USP

100000 IU

24

Cipla Ltd.
INDIA

Nystatin USP

100000 IU

24

Cipla Ltd.
INDIA

100 mg

36

Medopharm
INDIA

50 mg/2ml

36

Gland Pharma Ltd.


INDIA

75 mg/3ml

36

Gland Pharma Ltd.


INDIA

Digoxin,Injectable Solution

Nystatin,Tablet

Nystatin,Pessaries

Doxycycline Hyclate,Tablet

Doxycycline Hyclate BP

1,630 TAN 06,174 N04A IDA

Chlorpromazine,Injectable
Solution

Chlorpromazine
Hydrochloride BP

1,631 TAN 06,175 M01A IDA

Manufacturer

0.5 mg/ml

Neostigmine Metilsulphate
BP & Ph.Eur

1,626 TAN 06,170 C01A IDA

Shelf life
month

Diclofenac,Injectable Solution

Diclofenac Sodium BP

Page 256 of 584

Human Medicinal Products


S/No:

Registration Number

1,632 TAN 06,166 G02A IDA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Methylergometrine
Maleate,Injectable Solution

Lidocaine Hydrochloride 5%
and Dextrose 7.5%,Injectable
Dextrose USP
Solution

Lidocaine Hydrochloride
USP

1,634 TAN 06,157 H01B IDA

Gland Pharma Ltd.


INDIA

75 mg/ml
50 mg/ml

36

Gland Pharma Ltd.


INDIA

10 IU/ml

24

Gland Pharma Ltd.


INDIA

20 mg/2ml

36

Gland Pharma Ltd.


INDIA

Oxytocin,Injectable Solution

Oxytocin BP

1,635 TAN 06,156 C03C IDA

Furosemide,Injection

Frusemide USP

1,636 TAN 06,169 J01C IDA

1,637 TAN 07,061 A11H IDA

1,638 TAN 07,057 J01B IDA

Manufacturer

24

Methylergometrine Maleate 0.2 mg


USP

1,633 TAN 06,155 N01B IDA

Shelf life
month

Cloxacillin,Powder for
Injection

Cloxacillin Sodium
500 mg
equivalent to Cloxacillin BP

42

Vitamin A Oil Concentrate


BP

2000000 IU

36

1g

48

Karnataka Antibiotics &


Pharmaceuticals Ltd.
INDIA

Vitamin A,Capsules

Chloramphenicol 1g,Powder
for Injection

Chloramphenicol Sodium
Succinate BP

Page 257 of 584

Laboratoria Lambo N.V


BELGIUM

Karnataka Antibiotics &


Pharmaceuticals Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,639 TAN 07,062 J01H IDA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Fortified Procaine
Penicillin,Powder for Injection

Procaine Benzylpenicillin BP 3 MU

1,640 TAN 07,189 N01B IDA

Lidocaine
Hydrochloride,Injectable
Lidocaine Hydrochloride
Solution

Shelf life
month

36

1,643 TZ09H002

1,644 TAN 10,025 J01B IDA

2.4 MU

36

Calcium Chloride BP
Sodium Chloride BP
Potassium Chloride BP
Sodium Lactate IH

0.27 g
0.6 g
0.04 g
0.320 g

36

Albert David Ltd.


INDIA

Propranolol Hydrochloride
Ph Eur

40 mg

36

Pharmamed Ltd.
MALTA

250 mg

24

Micro Labs Ltd.


INDIA

50 mg
153.1 mg

36

IPCA Laboratories Ltd.


INDIA

Benzathine Penicillin,Powder
for Injection

Ringer Lactate,Intravenous
solution

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

Propranolol,Tablet

Chloramphenicol,Capsules

Chloramphenicol BP

1,645 TZ10H119

Gland Pharma Ltd


INDIA

36

Benzathine Penicillin USP

1,642 TAN 07,331 A12C IDA

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

1 %w/v

USP

1,641 TAN 07,188 J01H IDA

Manufacturer

Artesunate +
Amodiaquine,Tablets

Artesunate IH
Amodiaquine USP

Page 258 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
1,646 TAN 00,103 P02X IPC

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,648 TAN 00,160 P01A IPC

1,649 TAN 00,1088 J01K IPC

1,650 TAN 00,150 J01K IPC

1,651 TAN 00,153 P01B IPC

Manufacturer

IPCA Laboratories Ltd. - INDIA


Nemozole,Tablet
200 mg

36

IPCA Laboratories Ltd.


INDIA

Albendazole IH

100 mg/5ml

36

IPCA Laboratories Ltd.


INDIA

Cimetidine USP

400 mg

36

IPCA Laboratories Ltd.


INDIA

Sparfloxacin IH

200 mg

24

IPCA Laboratories Ltd.


INDIA

Norfloxacin USP

400 mg

36

IPCA Laboratories Ltd.


INDIA

Pyrimethamine USP
Sulfadoxine USP

25 mg
500 mg

36

IPCA Laboratories Ltd.


INDIA

Albendazole USP

1,647 TAN 00,151 P02X IPC

Shelf life
month

Nemozole,Suspension

Cimet,Tablet

Sparbact,Tablet

Normax,Tablet

Laridox,Tablet

Page 259 of 584

Human Medicinal Products


S/No:

Registration Number

1,652 TAN 00,162 A16 IPC

1,653 TAN 00,311 02B IPC

1,654 TAN 00,312 C06A IPC

1,655 TAN 00,043 R05C IPC

1,656 TAN 00,498 C01D IPC

1,657 TAN 00,499 C01E IPC

1,658 TAN 00,500 J01K IPC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Perinorm,Solution

Metoclopramide
Hydrochloride BP

5 mg/5ml

36

IPCA Laboratories Ltd.


INDIA

Paracetamol BP

500 mg

48

IPCA Laboratories Ltd.


INDIA

Atenolol BP

100 mg

36

IPCA Laboratories Ltd.


INDIA

Diphenhydramine
Hydrochloride BP
Menthol BP
Sodium Citrate BP
Ammonium Chloride BP

14 mg/5ml

36

IPCA Laboratories Ltd.


INDIA

Amlodipine Besylate BP

10 mg

24

IPCA Laboratories Ltd.


INDIA

Lisinopril USP

10 mg

24

IPCA Laboratories Ltd.


INDIA

36

IPCA Laboratories Ltd.


INDIA

Totopol,Tablet

Atenolol,Tablet

Pectylin C,Syrup

1.1 mg/5ml
57 mg/5ml
135 mg/5ml

Calchek,Tablet

Lisoril,Tablet

lomflox,Tablet

Lomefloxacin Hydrochloride 450 mg


IH

Page 260 of 584

Human Medicinal Products


S/No:

Registration Number

1,659 TAN 00,1436 C01 IPC

1,660 TAN 00,1622 B04A IPC

1,661 TAN 09,155 P01B IPC

1,662 TAN 00,4119 B01A IPC

1,663 TAN 00,1837 B04A IPC

1,664 TAN 00,1839 C01E IPC

1,665 TAN 00,4120 P01B IPC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Metagard,Tablet

Trimetazidine
Dihydrochloride BP

20 mg

24

IPCA Laboratories Ltd.


INDIA

Simvastatin USP

20 mg

24

IPCA Laboratories Ltd.


INDIA

Pyrimethamine USP
Sulfadoxine USP

25 mg/2.5ml
500 mg/2.5ml

12

IPCA Laboratories Ltd.


INDIA

Clopidogrel Bisulphate eq to 75 mg
Clopidogrel BP
75 mg
Clopidogrel Bisulfate IH

18

IPCA Laboratories Ltd.


INDIA

Simvastatin USP

10 mg

24

IPCA Laboratories Ltd.


INDIA

Losartan Potassium IH

50 mg

24

IPCA Laboratories Ltd.


INDIA

80 mg/ml

24

IPCA Laboratories Ltd.


INDIA

Simlo,Tablet

Laridox,Injection

Clopact,Tablet

Simlo,Tablet

Presartan,Tablet

Larither,Injectable Solution

Artemether IH

Page 261 of 584

Human Medicinal Products


S/No:

Registration Number

1,666 TAN 00,4121 C01E IPC

1,667 TAN 00,4603 A10B IPC

1,668 TAN 00,4604 A10B IPC

1,669 TAN 00,160 P01A IPC

1,670 TAN 00,160 P01A IPC

1,671 TAN 00,103 P02X IPC

1,672 TAN 00,151 P02X IPC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Presartan,Tablet

Losartan Potassium IH

25 mg

24

IPCA Laboratories Ltd.


INDIA

Gliclazide BP

80 mg

24

IPCA Laboratories Ltd.


INDIA

Gliclazide BP

40 mg

24

IPCA Laboratories Ltd.


INDIA

Cimetidine USP

400 mg

36

IPCA Laboratories Ltd.


INDIA

Cimetidine USP

400 mg

36

IPCA Laboratories Ltd.


INDIA

Albendazole USP

200 mg

36

IPCA Laboratories Ltd.


INDIA

100 mg/5ml

36

IPCA Laboratories Ltd.


INDIA

Glycinorm,Tablet

Glycinorm,Tablet

Cimet,Tablet

Cimet,Tablet

Nemozole,Tablet

Nemozole,Suspension

Albendazole IH

Page 262 of 584

Human Medicinal Products


S/No:

Registration Number

1,673 TAN 00,1088 J01K IPC

1,674 TAN 00,1088 J01K IPC

1,675 TAN 00,150 J01K IPC

1,676 TAN 00,153 P01B IPC

1,677 TAN 00,155 C06A IPC

1,678 TAN 00,162 A16 IPC

1,679 TAN 00,311 02B IPC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Sparbact,Tablet

Sparfloxacin IH

200 mg

24

IPCA Laboratories Ltd.


INDIA

Sparfloxacin IH

200 mg

24

IPCA Laboratories Ltd.


INDIA

Norfloxacin USP

400 mg

36

IPCA Laboratories Ltd.


INDIA

Pyrimethamine USP
Sulfadoxine USP

25 mg
500 mg

36

IPCA Laboratories Ltd.


INDIA

Atenolol BP

50 mg

36

IPCA Laboratories Ltd.


INDIA

Metoclopramide
Hydrochloride BP

5 mg/5ml

36

IPCA Laboratories Ltd.


INDIA

Paracetamol BP

500 mg

48

IPCA Laboratories Ltd.


INDIA

Sparbact,Tablet

Normax,Tablet

Laridox,Tablet

Tenolol,Tablet

Perinorm,Solution

Totopol,Tablet

Page 263 of 584

Human Medicinal Products


S/No:

Registration Number

1,680 TAN 00,312 C06A IPC

1,681 TAN 00,043 R05C IPC

1,682 TAN 00,498 C01D IPC

1,683 TAN 00,499 C01E IPC

1,684 TAN 00,500 J01K IPC

1,685 TAN 00,737 C01D IPC

1,686 TAN 05,665 J01C IPC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Atenolol,Tablet

Atenolol BP

100 mg

36

IPCA Laboratories Ltd.


INDIA

Diphenhydramine
Hydrochloride BP
Menthol BP
Sodium Citrate BP
Ammonium Chloride BP

14 mg/5ml

36

IPCA Laboratories Ltd.


INDIA

Amlodipine Besylate BP

10 mg

24

IPCA Laboratories Ltd.


INDIA

Lisinopril USP

10 mg

24

IPCA Laboratories Ltd.


INDIA

Lomefloxacin Hydrochloride 450 mg


IH

36

IPCA Laboratories Ltd.


INDIA

Amlodipine Besylate BP

24

IPCA Laboratories Ltd.


INDIA

24

IPCA Laboratories Ltd.


INDIA

Pectylin C,Syrup

1.1 mg/5ml
57 mg/5ml
135 mg/5ml

Calchek,Tablet

Lisoril,Tablet

lomflox,Tablet

Calcheck,Tablet
5 mg

Rapiclav,Tablet

Clavulanate Potassium BP 125 mg


Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP
Page 264 of 584

Human Medicinal Products


S/No:

Registration Number

1,687 TAN 05,666 J01H IPC

1,688 TAN 05,667 J01H IPC

1,689 TAN 05,776 P01B IPC

1,690 TAN 06,177 M01A IPC

1,691 TAN 00,1622 B04A IPC

1,692 TAN 06,415 C01L IPC

1,693 TAN 06,416 C01L IPC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Imox,Capsules

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

36

IPCA Laboratories Ltd.


INDIA

Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

36

IPCA Laboratories Ltd.


INDIA

50 mg
Artesunate IH
Amodiaquine Hydrochloride 150 mg
USP

24

IPCA Laboratories Ltd.


INDIA

Aceclofenac BP

100 mg

18

IPCA Laboratories Ltd.


INDIA

Simvastatin USP

20 mg

24

IPCA Laboratories Ltd.


INDIA

Atenolol Ph Eur
Chlorthalidone Ph Eur

100 mg
25 mg

18

IPCA Laboratories Ltd.


INDIA

Atenolol Ph Eur
Chlorthalidone Ph Eur

50 mg
12.5 mg

24

IPCA Laboratories Ltd.


INDIA

Imox,Dry Syrup
125 mg/5ml

Larimal,Tablet

Zerodol,Tablet

Simlo,Tablet

Tenoric,Tablet

Tenoric-50,Tablet

Page 265 of 584

Human Medicinal Products


S/No:

Registration Number

1,694 TAN 07,190 A04A IPC

1,695 TAN 00,4121 C01E IPC

1,696 TAN 00,4121 C01E IPC

1,697 TAN 00,4119 B01A IPC

1,698 TAN 08,119 C01E IPC

1,699 TAN 08,118 P01B IPC

1,700 TZ10H071

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Perinorm,Injectable Solution

Metoclopramide
Hydrochloride BP

5 mg/ml

24

IPCA Laboratories Ltd.


INDIA

Losartan Potassium IH

25 mg

24

IPCA Laboratories Ltd.


INDIA

Losartan Potassium IH

25 mg

24

IPCA Laboratories Ltd.


INDIA

Clopidogrel Bisulphate eq to 75 mg
Clopidogrel BP
75 mg
Clopidogrel Bisulfate IH

18

IPCA Laboratories Ltd.


INDIA

Hydrochlorthiazide BP
Losartan Potasium USP

12.5 mg
50 mg

24

IPCA Laboratories Ltd.


INDIA

Lumefantrine IH
Artemether IP

120 mg
20 mg

24

IPCA Laboratories Ltd.


INDIA

Metformin Hydrochloride BP 850 mg

24

IPCA Laboratories Ltd.


INDIA

Presartan,Tablet

Presartan,Tablet

Clopact,Tablet

Presartan,Tablet

Lumerax,Tablet

Emnorm,Tablets

Page 266 of 584

Human Medicinal Products


S/No:

Registration Number

1,701 TAN 00,498 C01D IPC

1,702 TAN 00,498 C01D IPC

1,703 TAN 00,737 C01D IPC

1,704 TAN 00,737 C01D IPC

1,705 TAN 05,665 J01C IPC

1,706 TAN 05,665 J01C IPC

1,707 TZ10H109

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Calchek,Tablet

Amlodipine Besylate BP

10 mg

24

IPCA Laboratories Ltd.


INDIA

Amlodipine Besylate BP

10 mg

24

IPCA Laboratories Ltd.


INDIA

Amlodipine Besylate BP

5 mg

24

IPCA Laboratories Ltd.


INDIA

Amlodipine Besylate BP

5 mg

24

IPCA Laboratories Ltd.


INDIA

Clavulanate Potassium BP 125 mg


Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

IPCA Laboratories Ltd.


INDIA

Clavulanate Potassium BP 125 mg


Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

IPCA Laboratories Ltd.


INDIA

Ramipril EP

24

IPCA Laboratories Ltd.


INDIA

Calchek,Tablet

Calcheck,Tablet

Calcheck,Tablet

Rapiclav,Tablet

Rapiclav,Tablet

Ramcor-2.5,Tablets

Page 267 of 584

2.5 mg

Human Medicinal Products


S/No:

Registration Number

1,708 TZ10H110

1,709 TZ11H008

1,710 TZ11H009

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,711 TAN 00,754 R01A IVE

Ramipril EP

10 mg

24

IPCA Laboratories Ltd.


INDIA

Ramipril EP

5.23 mg

24

IPCA Laboratories Ltd.


INDIA

20 mg
120 mg

24
Month
s

1 mg/ml

36

Ivee Aqua Epz Ltd


KENYA

Ramcor-5,Tablet

Artemether 20mg +
Lumefantrine 120mg
Artemether IP
Tablets,Tablet

1,712 TAN 00,1098 D010A JAN

1,713 TAN 00,1104 D01A JAN

IPCA Laboratories Ltd.


INDIA

Ivee Aqua Epz Ltd - KENYA


Ivynozvin A,Solution

Xylometazoline
Hydrochloride BP

Registrant

Manufacturer

Ramcor-10,Tablets

Lumefantrine IP

Registrant

Shelf life
month

Janseen Pharmaceutica (Pty) Ltd. - SOUTH AFRICA


Retin A,Cream

Tretinoin USP

0.05 g/100g

36

Cilag AG
SWITZERLAND

Econazole Nitrate Ph Eur

1 %w/w

60

Cilag AG
SWITZERLAND

Pevaryl,Cream

Page 268 of 584

Human Medicinal Products


S/No:

Registration Number

1,714 TAN 06,178 P02X JAN

1,715 TAN 06,304 N02B JAN

1,716 TAN 06,305 R05A JAN

1,717 TAN 07,064 M01A JAN

1,718 TAN 07,063 N02B JAN

Registrant
1,719 TAN 00,1105 M03A JAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Vermox SD,Suspension

Mebendazole Ph Eur

500 mg/10ml

24

Pseudoephedrine
Hydrochloride USP
Codeine Sulphate USP
Paracetamol EP

30 mg

24

Ibuprofen USP
Pseudoephedrine
Hydrochloride USP

200 mg
30 mg

24

Chlorpheniramine Maleate
USP
Dextromethorphan
Hydrobromide USP
Paracetamol USP
Pseudoephedrine
Hydrobromide USP

1 mg/5ml

24

Paracetamol USP
Pseudoephedrine
Hydrochloride USP

160 mg/5ml
15 mg/5ml

24

25 mg

60

Janseen Pharmaceutica
(Pty) Ltd.
SOUTH AFRICA

Sinumax CO,Tablet

8 mg
500 mg

Janseen Pharmaceutica
(Pty) Ltd.
SOUTH AFRICA

Sinumax IB,Caplets
Janseen Pharmaceutica
(Pty) Ltd.
SOUTH AFRICA

Sinumax,Liquid

5 mg/5ml

Janseen Pharmaceutica
(Pty) Ltd.
SOUTH AFRICA

160 mg/5ml
15 mg/5ml

Sinumax Ped,Syrup
Janseen Pharmaceutica
(Pty) Ltd.
SOUTH AFRICA

Janssen - Cilag SpA - ITALY


Stugeron,Tablet

Cinnarizine Ph Eur

Page 269 of 584

Janssen - Cilag SpA


ITALY

Human Medicinal Products


S/No:

Registration Number

Registrant
1,720 TAN 00,016 D01A JAN

1,721 TAN 00,114 D07X JAN

1,722 TAN 00,115 D01A JAN

1,723 TAN 00,116 G02C JAN

1,724 TAN 00,117 A07X JAN

1,725 TAN 00,118 R01A JAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Janssen Pharmaceutica (Pty) Ltd. - SOUTH AFRICA


Daktarin,Cream

Miconazole Nitrate USP

20 mg/g

36

Janssen Pharmaceutica N.V


BELGIUM

Miconazole Nitrate USP


Hydrocortisone USP

20 mg/g
10 mg/g

36

Janssen Pharmaceutica N.V


BELGIUM

Miconazole Nitrate Ph Eur

20 mg

60

Janssen Pharmaceutica N.V


BELGIUM

Miconazole Nitrate USP

20 mg/g

36

Janssen Pharmaceutica N.V


BELGIUM

Loperamide Hydrochloride
Ph Eur

2 mg

60

Janssen Pharmaceutica N.V


BELGIUM

Levocabastine
Hydrochloride IH

0.5 mg/ml

36

Janssen Pharmaceutica N.V


BELGIUM

Daktacort,Cream

Daktarin,Powder

Gyno Daktarin,Cream

Imodium,Capsules

Livostin,Spray

Page 270 of 584

Human Medicinal Products


S/No:

Registration Number

1,726 TAN 00,119 A04A JAN

1,727 TAN 00,120 A04A JAN

1,728 TAN 00,121 D01A JAN

1,729 TAN 00,568 D01A JAN

1,730 TAN 00,1092 D010A JAN

1,731 TAN 00,1098 D010A JAN

1,732 TAN 00,1102 D01A JAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Motilium,Suspension

Domperidone IH

1 mg/ml

60

Janssen Pharmaceutica N.V


BELGIUM

Domperidone Ph Eur

10 mg

60

Janssen Pharmaceutica N.V


BELGIUM

Ketoconazole USP

20 mg/g

60

Janssen Pharmaceutica N.V


BELGIUM

Miconazole Nitrate Ph Eur

20 mg/100g

36

Janssen Pharmaceutica N.V


BELGIUM

Tretinoin Ph Eur

0.025 g/100g

36

EIPICO
EGYPT

Tretinoin Ph Eur

0.05 g/100g

36

Cilag AG
SWITZERLAND

36

Cilag AG
SWITZERLAND

Motilium,Tablet

Nizoral,Cream

Daktarin,Gel

Retin A,Gel

Retin A,Cream

Pevisone,Cream

Triamcinolone Acetonide Ph 0.11 %w/w


Eur
0.11 %w/w
Econazole Nitrate Ph Eur

Page 271 of 584

Human Medicinal Products


S/No:

Registration Number

1,733 TAN 00,1104 D01A JAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,735 TAN 00,017 J02A JAN

1,736 TAN 00,114 D07X JAN

1,737 TAN 00,115 D01A JAN

1,738 TAN 00,116 G02C JAN

1,739 TAN 00,1092 D010A JAN

Manufacturer

Pevaryl,Cream
1 %w/w

60

Cilag AG
SWITZERLAND

Miconazole Nitrate Ph Eur

400 mg

60

Janssen Pharmaceutica N.V


BELGIUM

Ketoconazole Ph Eur

200 mg

60

Janssen Pharmaceutica N.V


BELGIUM

Miconazole Nitrate USP


Hydrocortisone USP

20 mg/g
10 mg/g

36

Janssen Pharmaceutica N.V


BELGIUM

Miconazole Nitrate Ph Eur

20 mg

60

Janssen Pharmaceutica N.V


BELGIUM

Miconazole Nitrate USP

20 mg/g

36

Janssen Pharmaceutica N.V


BELGIUM

Tretinoin USP

0.025 g/100g

36

EIPICO
EGYPT

Econazole Nitrate Ph Eur

1,734 TAN 00,1626 D01A JAN

Shelf life
month

Gyno Daktarin,Pessaries

Nizoral,Tablet

Daktacort,Cream

Daktarin,Powder

Gyno Daktarin,Cream

Retin A,Gel

Page 272 of 584

Human Medicinal Products


S/No:

Registration Number

1,740 TAN 00,1102 D01A JAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

36

Cilag AG
SWITZERLAND

400 mg

60

Janssen Pharmaceutica N.V


BELGIUM

400 mg

60

Janssen Pharmaceutica N.V


BELGIUM

2 mg/ml

20

Ben. Venue Laboratories


USA

Gyno Daktarin,Pessaries

Miconazole Nitrate Ph Eur

1,742 TAN 00,1626 D01A JAN

Gyno Daktarin,Pessaries

Miconazole Nitrate Ph Eur

1,743 TAN 09,205 L01C SCH

Caelyx,Injectable Solution

Doxorubicin Hydrochloride
USP

Registrant
1,744 TAN 00,915 R05F WAR

Johnson & Johnson (Pty) Ltd. - SOUTH AFRICA


Benylin DMD
Decongestant,Syrup

Diphenhydramine
Hydrochloride USP
Pseudoephedrine
Hydrochloride USP

1,745 TAN 00,918 D02A WAR

Manufacturer

Pevisone,Cream

Triamcinolone Acetonide Ph 0.11 %w/w


Eur
1.00 %w/w
Econazole Nitrate Ph Eur
1,741 TAN 00,1626 D01A JAN

Shelf life
month

15 mg/5ml

24

30 ml/5ml

Warner-Lambert S.A (Pty)


Ltd.
SOUTH AFRICA

Anusol,Suppositories

Bismuth Subgallate BP
Bismuth Oxide IH
Zinc Oxide USP

Page 273 of 584

59 mg
24 mg
296 mg

24

Johnson & Johnson (Pty)


Ltd.
SOUTH AFRICA

Human Medicinal Products


S/No:

Registration Number

1,746 TAN 00,919 R05F WAR

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,748 TAN 00,923 D02A WAR

1,749 TAN 00,927 R05F WAR

1,750 TAN 06,094 D08A PFI

1,751 TAN 06,094 D08A PFI

Manufacturer

Benylin Original,Syrup

Diphenhydramine
Hydrochloride USP
Ammonium Chloride USP
1,747 TAN 00,920 R05A WAR

Shelf life
month

12.5 mg/5ml

24

125 mg/5ml

Warner-Lambert S.A (Pty)


Ltd.
SOUTH AFRICA

Sinutab Original,Tablet

Phenyltolaxamine Citrate IH 22 mg
300 mg
Paracetamol USP
Phenylpropanolamine
25 mg
Hydrochloride USP

24

Bismuth Oxide IH
Bismuth Subgallate IH
Zinc Oxide IH

8.75 mg
22.5 mg
100 mg

24

Diphenhydramine
Hydrochloride USP

15 mg/5ml

48

Thymol IH
Alcohol(95%) USP

12.78 mg/20ml
4.54 ml/20ml

36

Thymol IH
Alcohol(95%) USP

12.78 mg/20ml
4.54 ml/20ml

36

Warner-Lambert S.A (Pty)


Ltd.
SOUTH AFRICA

Anusol,Ointment
Warner-Lambert S.A (Pty)
Ltd.
SOUTH AFRICA

Benylin,Syrup
Twiga Chemical Industries
TANZANIA

Listerine,Solution
Pfizer Global
Manufacturing, A Division
of Pfizer
SOUTH AFRICA

Listerine,Solution

Page 274 of 584

Pfizer Global
Manufacturing, A Division
of Pfizer
SOUTH AFRICA

Human Medicinal Products


S/No:

Registration Number

1,752 TAN 00,1669 S01D PFI

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,753 TAN 00,4167 P02X SHI

1,754 TAN 00,4167 P02X SHI

1,755 TAN 00,4167 P02X SHI

Registrant
1,756 TAN 00,4605 P01B KAM

7.5 mg/15ml

60

Albendazole USP

400 mg

60

Albendazole USP

400 mg

60

Albendazole USP

400 mg

60

Pfizer Canada Inc


CANADA

K&C Trading Co. Ltd. - TANZANIA


Alzental,Tablet
Shin Poong Pharmaceutical
Co.Ltd
KOREA

Alzental,Tablet
Shin Poong Pharmaceutical
Co.Ltd
KOREA

Alzental,Tablet
Shin Poong Pharmaceutical
Co.Ltd
KOREA

Kampala Pharmaceutical Industries (1996) Ltd - UGANDA


Kam Quinine,Syrup

Quinine Hydrochloride BP

1,757 TAN 00,4605 P01B KAM

Manufacturer

Visine,Ophthalmic Solution

Tetrahydrozoline
Hydrochloride USP

Registrant

Shelf life
month

100 mg/5ml

24

100 mg/5ml

24

Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Kam Quinine,Syrup

Quinine Hydrochloride BP

Page 275 of 584

Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Human Medicinal Products


S/No:

Registration Number

1,758 TAN 00,4605 P01B KAM

1,759 TAN 00,1627 D01A KMP

1,760 TAN 00,1106 P01B KMP

1,761 TAN 00,1438 D01A KMP

1,762 TAN 00,2578 R05A KAM

1,763 TAN 08,140 R05A KAM

1,764 TAN 00,4123 R03A KAM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Kam Quinine,Syrup

Quinine Hydrochloride BP

100 mg/5ml

24

Clotrimazole USP

1 %w/w

24

Quinine Sulphate BP

300 mg

18

Prednisolone BP

5 mg

36

Chlorpheniramine Maleate
BP
Paracetamol BP
Pseudoephedrine
Hydrochloride BP

1.25 mg/5ml

36

Pheniramine maleate BP
Acetaminophen USP

10.5 mg
500 mg

Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Camston,Cream
Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Quine,Tablet
Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Kam Predsol,Tablet
Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Flucap,Syrup

120 mg/5ml
10 mg/5ml

Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Flurid,Tablet

Flucap,Capsules

Page 276 of 584

24

Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Human Medicinal Products


S/No:

Registration Number

1,765 TAN 00,1627 D01A KMP

Registrant
1,766 TAN 00,1629 J01H KRA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Caffeine Anhydrous BP
Chlorpheniramine Maleate
BP
Paracetamol BP
Pseudoephedrine BP

30 mg
4 mg

Clotrimazole USP

1 %w/w

400 mg
30 mg

24

Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

PPF,Powder for Injection

Ceftriaxone,Powder for
Injection

Ampicillin +
Cloxacillin,Powder for
Ampicillin Sodium
Injection

equivalent to Ampicillin IH
Cloxacillin Sodium
equivalent to Cloxacillin IH

1,769 TAN 07,332 J01C KAR

Kampala Pharmaceutical
Industries (1996) Ltd
UGANDA

Karnataka Antibiotics & Pharmaceuticals Ltd. - INDIA

Ceftriaxone Sodium
equivalent to Ceftriaxone
USP

1,768 TAN 07,334 J01C KAR

36

Manufacturer

Camston,Cream

Fortified Procaine
Benzylpenicillin BP

1,767 TAN 07,333 J01D KAR

Shelf life
month

Co Amoxiclav,Powder for
Injection

Potassium Clavunate
Equivalent to Clavulanic
Acid BP
Amoxicillin Sodium BP

Page 277 of 584

0.4 MU

36

250 mg

24

250 mg

36

250 mg

100 mg/vial

500 mg/vial

24

Karnataka Antibiotics &


Pharmaceuticals Ltd.
INDIA

Karnataka Antibiotics &


Pharmaceuticals Ltd.
INDIA

Karnataka Antibiotics &


Pharmaceuticals Ltd.
INDIA

Karnataka Antibiotics &


Pharmaceuticals Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,770 TAN 07,491 J01D KAR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Ceftriaxone,Powder for
Injection

Ceftriaxone Sodium
equivalent to Ceftriaxone
USP

1,771 TAN 00,1628 J01H KRA

Registrant
1,772 B718

Sterile Penicillin G
Benzathine,Powder for
Penicillin G Benzathine USP 2.4 MU
Injection

Karnataka Antibiotics &


Pharmaceuticals Ltd.
INDIA

5 mg

60

Kejo Super Sembe


TANZANIA

400 mg
80 mg

60

Kejo Super Sembe


TANZANIA

200 mg

24

Kejo Super Sembe


TANZANIA

1 mg

24

Kejo Super Sembe


TANZANIA

Co-trimoxazole,Tablet

Metronidazole,Tablet

Metronidazole BP

1,775 B723

36

Karnataka Antibiotics &


Pharmaceuticals Ltd.
INDIA

Diazepam,Tablet

Sulfamethoxazole BP
Trimethoprim BP

1,774 B722

36

Manufacturer

KEKO PHARMACETICAL INDUSTRIES (1997) LTD - TANZANIA


Diazepam BP

1,773 B719

1000 mg

Shelf life
month

Vitamin B Complex,Tablet

Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Hydrochloride BP
Calcium Pantothenate BP
Nicotinamide BP
Riboflavin BP

Page 278 of 584

1 mg
0.5 mg
15 mg
1 mg

Human Medicinal Products


S/No:

Registration Number

1,776 B757

1,777 B777

1,778 B778

1,779 C800

1,780 D088

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,782 D090

Manufacturer

Magnesium,Tablet

Aluminium Hydroxide BP
Magnesium Trisilicate BP

120 mg
250 mg

60

Kejo Super Sembe


TANZANIA

Acetylsalicylic Acid BP

300 mg

24

Kejo Super Sembe


TANZANIA

Paracetamol BP

500 mg

24

Kejo Super Sembe


TANZANIA

Amodiaquine Hydrochloride 200 mg


USP

24

Kejo Super Sembe


TANZANIA

36

Kejo Super Sembe


TANZANIA

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

Kejo Super Sembe


TANZANIA

Anhydrous Glucose BP
Sodium Chloride BP
Potassium Chloride BP
Sodium Citrate Dihydrate
BP

12

Kejo Super Sembe


TANZANIA

Aspirin,Tablet

Paracetamol,Tablet

Amodiaquine,Tablet

Bendrofluazide,Tablet

Bendrofluazide BP

1,781 D089

Shelf life
month

5 mg

Diomox,Capsules

Diolite,Powder for
Reconstitution

Page 279 of 584

20 g
3.5 g
1.5 g
2.9 g

Human Medicinal Products


S/No:

Registration Number

1,783 D724

1,784 D725

1,785 D726

1,786 D727

1,787 D728

1,788 D729

1,789 D730

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Diofenac,Tablet

Diclofenac Sodium BP

50 mg

24

Kejo Super Sembe


TANZANIA

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

36

Kejo Super Sembe


TANZANIA

Erythromycin Stearate eq to 250 mg


Erythromycin BP

24

Kejo Super Sembe


TANZANIA

Mebendazole USP

100 mg

24

Kejo Super Sembe


TANZANIA

Doxycycline Hydrochloride
BP

100 mg

24

Kejo Super Sembe


TANZANIA

Prazinquatel USP

600 mg

24

Kejo Super Sembe


TANZANIA

30 mg

24

Kejo Super Sembe


TANZANIA

Diocillin,Capsules

Diomycin,Tablet

Diobenda,Tablet

Diodox,Capsules

Diopraz,Tablet

Phenobarbitone,Tablet

Phenobarbitone BP

Page 280 of 584

Human Medicinal Products


S/No:

Registration Number

1,790 D811

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,792 D863

1,793 E281

1,794 E282

1,795 E329

1,796 E330

Manufacturer

Dionsdar,Tablet
25 mg
500 mg

24

Kejo Super Sembe


TANZANIA

Ampicillin BP
Cloxacillin BP

250 mg
250 mg

24

Kejo Super Sembe


TANZANIA

Cloxacillin BP

250 mg

24

Kejo Super Sembe


TANZANIA

Ciprofloxacin BP

250 mg

24

Kejo Super Sembe


TANZANIA

Cimetidine BP

400 mg

24

Kejo Super Sembe


TANZANIA

Amoxicillin Trihydrate BP

125 mg/5ml

24

Kejo Super Sembe


TANZANIA

Metronidazole BP

250 mg

24

Kejo Super Sembe


TANZANIA

Pyrimethamine BP
Sulfadoxine BP

1,791 D862

Shelf life
month

Dioamplox,Capsules

Dioclox,Capsules

Diocipro,Tablet

Cimetidine,Tablet

Diomox,Suspension

Diogyl 250,Tablet

Page 281 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
1,797 TAN 00,1630 B03A KEL

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,798 TAN 00,1903 A11A SHA

Gestiferrol,Tablet
200 mg
500 mcg

1,799 TAN 00,1113 C01K KOP

1,800 TAN 00,1121 C01K KOP

1,801 TAN 07,500 J01H KOP

Trishal Forte,Injectable
Solution

Kela N.V
BELGIUM

24

Kilitch Drugs (India) Ltd


INDIA

Kopran Ltd. - INDIA


Aten,Tablet

Atenolol BP

50 mg

36

Kopran Ltd.
INDIA

Amlodipine Besylate IH

5 mg

24

Kopran Ltd.
INDIA

36

Kopran Ltd.
INDIA

36

Kopran Ltd.
INDIA

Klodip,Tablet

Amyn,Powder for Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

1,802 TAN 07,499 J01H KOP

30

Kilitch Drugs (India) Ltd - INDIA


1 mg/ml
Cyanocobalamin BP
Pyridoxine Hydrochloride
55 mg/ml
Ascorbic Acid BP
Thiamine Hydrochloride BP 55 mg/ml

Registrant

Manufacturer

Kela N.V - BELGIUM


Ferrous Fumarate Ph Eur
Folic Acid Ph Eur

Registrant

Shelf life
month

Amyn-250,Capsules

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

Page 282 of 584

Human Medicinal Products


S/No:

Registration Number

1,803 TAN 08,142 J01H KOP

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,804 TAN 00,666 D01A DON

1,805 TAN 00,667 P02X DON

1,806 TAN 00,666 D01A DON

1,807 TAN 00,666 D01A DON

1,808 TAN 00,667 P02X DON

Manufacturer

Ampik,Capsules

Ampicillin Trihydrate
equivalent to Ampicillin BP

Registrant

Shelf life
month

250 mg

36

Kopran Ltd.
INDIA

36

Korea Arlico Pharm Co. Ltd.


KOREA

Korea Arlico Pharmaceutical Co.Ltd - KOREA


Acrasone,Cream

Clotrimazole USP
Betamethasone
Dipropionate USP
Gentamycin Sulphate USP

10 %w/w
0.640 %w/w

Albendazole USP

400 mg

36

Korea Arlico Pharm Co. Ltd.


KOREA

Clotrimazole USP
Betamethasone
Dipropionate USP
Gentamycin Sulphate USP

10 %w/w
0.640 %w/w

36

Korea Arlico Pharm Co. Ltd.


KOREA

Clotrimazole USP
Betamethasone
Dipropionate USP
Gentamycin Sulphate USP

10 %w/w
0.640 %w/w

36

Korea Arlico Pharm Co. Ltd.


KOREA

Albendazole USP

400 mg

36

Korea Arlico Pharm Co. Ltd.


KOREA

1 %w/w

Albi,Tablet

Acrasone,Cream

1 %w/w

Acrasone,Cream

1 %w/w

Albi,Tablet

Page 283 of 584

Human Medicinal Products


S/No:

Registration Number

1,809 TAN 00,667 P02X DON

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,810 TZ10H135

36

Korea Arlico Pharm Co. Ltd.


KOREA

10 mg

36

Kotra Pharma (M) Sdn Bhd


MALAYSIA

Cetrizine Dihydrochloride
IH

5 mg/5ml

36

Kotra Pharma (M) Sdn Bhd


MALAYSIA

1,812 TZ10H137

Cefuroxime Axetil
equivalent to Cefuroxime
USP

250 mg

24

Kotra Pharma (M) Sdn Bhd


MALAYSIA

1,813 TZ10H138

1g

24

Kotra Pharma (M) Sdn Bhd


MALAYSIA

Axcel Cetirizine,Tablets

Axcel Cetirizine,Syrup

Axcel Cefuroxime 250,Capsules

Vaxcel Ceftriaxone 1G,Injection

Ceftriaxone Sodium eq to
Ceftriaxone USP

Registrant
1,814 TZ11H183

400 mg

Kotra Pharma (M) Sdn Bhd - MALAYSIA


Cetrizine Dihydrochloride
BP

1,811 TZ10H136

Manufacturer

Albi,Tablet

Albendazole USP

Registrant

Shelf life
month

Kunming Dihon Pharmaceutical Co.Ltd - CHINA


Skineal,Cream

Ketoconazole Ch.P.2005
Clobetasol Propionate
Ch.P.2005
Neomycin Sulphate
Ch.P.2005

Page 284 of 584

10 mg
0.25 mg
5000mg calculated as
per Neomycin mg

36

Kunming Dihon
Pharmaceutical Co.Ltd
CHINA

Human Medicinal Products


S/No:

Registration Number

Registrant
1,815 TAN 06,417 P01B KUN

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,817 TAN 08,143 P01B KUN

Registrant
1,818 TAN 00,342 P02X KUN

Artem,Injectable Solution
80 mg/ml

48

Artemether IH

40 mg/0.5ml

48

Artemisinin IH
Naphthoquine IH

125 mg
50 mg

36

1,820 TAN 00,2584 A10B LAB

Kunming Pharmaceutical
Corporation
CHINA

Arco,Tablet
Kunming Pharmaceutical
Corporation
CHINA

Kunming Pharmaceutical Corporation - CHINA


Artemidine,Injection

Artemedine,Injectable
Solution

Artemether BP

Registrant

Kunming Pharmaceutical
Corporation
CHINA

Artem,Injectable Solution

Artemether IH

1,819 TAN 00,4127 P01B KUN

Manufacturer

Kunming Pharmaceutical Corp - CHINA


Artemether IH

1,816 TAN 06,418 P01B KUN

Shelf life
month

80 mg/ml

36

80 mg/0.5ml

48

Kunming Pharmaceutical
Corporation
CHINA

Kunming Pharmaceutical
Corporation
CHINA

Laboratori Guidoti, S.P.A - ITALY


Metforal,Tablet

Metformin Hydrochloride Ph 850mg mg


Eur

Page 285 of 584

36

Berlin-Chemie AG
GERMANY

Human Medicinal Products


S/No:

Registration Number

1,821 TAN 00,2584 A10B LAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,822 TAN 00,1862 D07A LAA

1,823 TAN 00,1856 V04A LAA

1,824 TAN 00,1862 D07A LAA

1,825 TAN 00,1870 J01H LAA

1,826 TAN 00,1875 A02A LAA

Manufacturer

Metforal,Tablet

Metformin Hydrochloride Ph 850mg mg


Eur

Registrant

Shelf life
month

36

Berlin-Chemie AG
GERMANY

Laboratories & Allied Ltd - KENYA


Labesten,Pessaries

Clotrimazole BP

100 mg

60

Laboratories & Allied Ltd


KENYA

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

36

Laboratories & Allied Ltd


KENYA

Clotrimazole BP

100 mg

60

Laboratories & Allied Ltd


KENYA

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

48

Laboratories & Allied Ltd


KENYA

0.12 g/100ml
1.2 g/100ml
0.5 g/100ml
0.5 g/100ml

24

Laboratories & Allied Ltd


KENYA

Lecotrim,Tablet

Labesten,Pessaries

Lacillin,Capsules

Baby Gripe solution,Solution

Anise Oil BP
Sodium Bicarbonate BP
Sodium Citrate BP
Strong Ginger Tincture BP

Page 286 of 584

Human Medicinal Products


S/No:

Registration Number

1,827 TAN 00,2620 P02X PHD

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,829 TAN 00,4129 P02X LAB

1,830 TAN 00,4129 P02X LAB

1,831 TAN 00,4474 P01A LAB

1,832 TAN 00,1989 R03A LAA

1,833 TAN 00,4606 P01B LAB

Manufacturer

Natoa,Suspension
36

Laboratories & Allied Ltd


KENYA

Amodiaquine Hydrochloride 200 mg


BP

36

Laboratories & Allied Ltd


KENYA

Levamisole Hydrochloride
BP

40 mg

36

Laboratories & Allied Ltd


KENYA

Levamisol Hydrochloride BP 48 mg

36

Laboratories & Allied Ltd


KENYA

Metronidazole BP

200 mg

36

Laboratories & Allied Ltd


KENYA

Ephedrine Hydrochloride
BP
Theophyline BP

11 mg

36

Laboratories & Allied Ltd


KENYA

36

Laboratories & Allied Ltd


KENYA

Mebendazole BP

1,828 TAN 00,2611 P01B PHD

Shelf life
month

100 mg/5ml

Laequin,Tablet

Letrax,Tablet

Letrax,Tablet

Tricozole,Tablet

Gifol,Tablet

120 mg

Laeoquin,Suspension

Amodiaquine Hydrochloride 50 mg/5ml


USP

Page 287 of 584

Human Medicinal Products


S/No:

Registration Number

1,834 TAN 05,181 N04C LAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,837 TAN 00,2585 N02B LAB

1,838 TAN 00,1870 J01H LAA

1,839 TAN 00,1870 J01H LAA

1,840 TAN 00,1871 J01F LAA

5 mg

36

Laboratories & Allied Ltd


KENYA

2 mg/5ml

24

Laboratories & Allied Ltd


KENYA

Cophydrex,Expectorant

Chlorpheniramine Maleate
BP
Diphenhydramine
Hydrochloride BP
Ammonium Chloride BP
1,836 TAN 05,505 P01B LAB

Manufacturer

Calm-5,Tablet

Diazepam BP

1,835 TAN 05,182 R05F LAB

Shelf life
month

Quinine
Dihydrochloride,Injection

5 mg/5ml
60 mg/5ml

Quinine Dihydrochloride
BP

300 mg/ml

36

Laboratories & Allied Ltd


KENYA

Caffeine NA
Acetylsalicylic Acid NA

30 mg
350 mg

36

Laboratories & Allied Ltd


KENYA

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

48

Laboratories & Allied Ltd


KENYA

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

48

Laboratories & Allied Ltd


KENYA

Erythromycin Stearate
equivalent to Erythromycin
BP

250 mg

24

Laboratories & Allied Ltd


KENYA

Nopen,Tablet

Lacillin,Capsules

Lacillin,Capsules

Erocin,Tablet

Page 288 of 584

Human Medicinal Products


S/No:

Registration Number

1,841 TAN 00,1871 J01F LAA

1,842 TAN 00,1854 V04A LAA

1,843 TAN 00,1862 D07A LAA

1,844 TAN 00,1862 D07A LAA

1,845 TAN 00,1874 N02B LAA

1,846 TAN 07,335 N02B LAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Erocin,Tablet

Erythromycin Stearate
equivalent to Erythromycin
BP

250 mg

24

Laboratories & Allied Ltd


KENYA

Nystatin BP

100000 IU

24

Laboratories & Allied Ltd


KENYA

Clotrimazole BP

100 mg

60

Laboratories & Allied Ltd


KENYA

Clotrimazole BP

100 mg

60

Laboratories & Allied Ltd


KENYA

Acetaminophen BP

500 mg

36

Laboratories & Allied Ltd


KENYA

120 mg/5ml

24

Laboratories & Allied Ltd


KENYA

36

Laboratories & Allied Ltd


KENYA

Labstatin V,Tablet

Labesten,Pessaries

Labesten,Pessaries

Dentamol,Tablet

Totomol,Suspension

Paracetamol BP

1,847 TAN 00,2611 P01B PHD

Shelf life
month

Laequin,Tablet

Amodiaquine Hydrochloride 200 mg


BP

Page 289 of 584

Human Medicinal Products


S/No:

Registration Number

1,848 TAN 00,2611 P01B PHD

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,851 TAN 00,4298 P01B LAB

1,852 TAN 00,1855 V04A LAA

24

Laboratories & Allied Ltd


KENYA

Phenobarbitone BP

30 mg

36

Laboratories & Allied Ltd


KENYA

Pyrimethamine BP
Sulfamethopyrazine IH

25 mg
500 mg

36

Laboratories & Allied Ltd


KENYA

100 mg

36

Laboratories & Allied Ltd


KENYA

133.7 mg

36

Laboratories & Allied Ltd


KENYA

1 %w/w

36

Laboratories & Allied Ltd


KENYA

Laefin,Tablet

Aminophylline,Tablet

Hycorum,Injectable Solution

Hydrocortisone Sodium
USP

1,854 TAN 00,1858 S01A LAA

Laboratories & Allied Ltd


KENYA

Phenorbarbitone,Tablet

Aminophylline BP

1,853 TAN 00,1857 H02A LAA

36

Kemoxyl,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

1,850 TAN 00,1868 N04C LAA

Manufacturer

Laequin,Tablet

Amodiaquine Hydrochloride 200 mg


BP

1,849 TAN 00,4128 J01H LAB

Shelf life
month

Racycline,Ophthalmic
Ointment

Tetracycline Hydrochloride
BP

Page 290 of 584

Human Medicinal Products


S/No:

Registration Number

1,855 TAN 00,1865 J03B LAA

1,856 TAN 00,1867 D01A LAA

1,857 TAN 00,1869 J01K LAA

1,858 TAN 00,1873 P01A LAA

1,859 TAN 00,4474 P01A LAB

1,860 TAN 00,4474 P01A LAB

1,861 TAN 00,4606 P01B LAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Lecotrim,Suspension

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

36

Laboratories & Allied Ltd


KENYA

Clotrimazole BP

1 %w/w

36

Laboratories & Allied Ltd


KENYA

Nystatin USP

100000 IU

30

Laboratories & Allied Ltd


KENYA

Tinidazole BP

500 mg

48

Laboratories & Allied Ltd


KENYA

Metronidazole BP

200 mg

36

Laboratories & Allied Ltd


KENYA

Metronidazole BP

200 mg

36

Laboratories & Allied Ltd


KENYA

36

Laboratories & Allied Ltd


KENYA

Labesten,Cream

Labstatin,Suspension

Tynazole,Tablet

Tricozole,Tablet

Tricozole,Tablet

Laeoquin,Suspension

Amodiaquine Hydrochloride 50 mg/5ml


USP

Page 291 of 584

Human Medicinal Products


S/No:

Registration Number

1,862 TAN 00,4606 P01B LAB

1,863 TAN 00,1988 P02X LAA

1,864 TAN 05,181 N04C LAB

1,865 TAN 05,181 N04C LAB

1,866 TAN 05,182 R05F LAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Laeoquin,Suspension

Amodiaquine Hydrochloride 50 mg/5ml


USP

36

Laboratories & Allied Ltd


KENYA

Mebendazole BP

100 mg

36

Laboratories & Allied Ltd


KENYA

Diazepam BP

5 mg

36

Laboratories & Allied Ltd


KENYA

Diazepam BP

5 mg

36

Laboratories & Allied Ltd


KENYA

2 mg/5ml

24

Laboratories & Allied Ltd


KENYA

24

Laboratories & Allied Ltd


KENYA

Natoa,Tablet

Calm-5,Tablet

Calm-5,Tablet

Cophydrex,Expectorant

Chlorpheniramine Maleate
BP
Diphenhydramine
Hydrochloride BP
Ammonium Chloride BP
1,867 TAN 05,182 R05F LAB

Shelf life
month

5 mg/5ml
60 mg/5ml

Cophydrex,Expectorant

Chlorpheniramine Maleate
BP
Diphenhydramine
Hydrochloride BP
Ammonium Chloride BP

Page 292 of 584

2 mg/5ml
5 mg/5ml
60 mg/5ml

Human Medicinal Products


S/No:

Registration Number

1,868 TAN 00,2585 N02B LAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,870 TAN 00,1871 J01F LAA

1,871 TAN 00,1873 P01A LAA

1,872 TAN 00,1868 N04C LAA

30 mg
350 mg
30 mg

36

Laboratories & Allied Ltd


KENYA

Phenobarbitone BP

30 mg

36

Laboratories & Allied Ltd


KENYA

Erythromycin Stearate
equivalent to Erythromycin
BP

250 mg

24

Laboratories & Allied Ltd


KENYA

Tinidazole BP

500 mg

48

Laboratories & Allied Ltd


KENYA

30 mg

36

Laboratories & Allied Ltd


KENYA

Phenobarbitone BP

30 mg

36

Laboratories & Allied Ltd


KENYA

Hydrocortisone Sodium
USP

133.7 mg

36

Laboratories & Allied Ltd


KENYA

Phenorbarbitone,Tablet

Erocin,Tablet

Tynazole,Tablet

Phenorbarbitone,Tablet

Phenobarbitone BP

1,873 TAN 00,1868 N04C LAA

1,874 TAN 00,1857 H02A LAA

Manufacturer

Nopen,Tablet

Caffeine Anhydrous BP
Acetylsalicylic Acid BP
Caffeine NA
1,869 TAN 00,1868 N04C LAA

Shelf life
month

Phenorbarbitone,Tablet

Hycorum,Injection

Page 293 of 584

Human Medicinal Products


S/No:

Registration Number

1,875 TAN 00,1857 H02A LAA

Product Name
Pack and Pack size

Ingredient(s) and Strength

133.7 mg

36

Laboratories & Allied Ltd


KENYA

200 mg/5ml
40 mg/5ml

36

Laboratories & Allied Ltd


KENYA

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

36

Laboratories & Allied Ltd


KENYA

Tinidazole BP

500 mg

48

Laboratories & Allied Ltd


KENYA

Tinidazole BP

500 mg

48

Laboratories & Allied Ltd


KENYA

0.0525 %w/w

36

Laboratories & Allied Ltd


KENYA

Lecotrim,Suspension

Sulfamethoxazole BP
Trimethoprim BP

1,877 TAN 00,1865 J03B LAA

1,878 TAN 00,1873 P01A LAA

1,879 TAN 00,1873 P01A LAA

1,880 TAN 00,1858 S01A LAA

Lecotrim,Suspension

Tynazole,Tablet

Tynazole,Tablet

Racycline,Eye Ointment

Tetracycline Hydrochloride
BP

Registrant

Manufacturer

Hycorum,Injection

Hydrocortisone Sodium
USP

1,876 TAN 00,1865 J03B LAA

Shelf life
month

Laboratories for Applied Biology Ltd. - UNITED KINGDOM

Page 294 of 584

Human Medicinal Products


S/No:

Registration Number

1,881 TAN 00,1633 S02D LBA

1,882 TAN 00,1633 S02D LBA

1,883 TAN 00,1633 S02D LBA

Registrant
1,884 TAN 00,2047 V03A STE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Arachis Oil BP
Paradichlorobenzene BP
Chlorbutanol BP

574 mg/ml
20 mg/ml
50 mg/ml

60

Arachis Oil BP
Paradichlorobenzene BP
Chlorbutanol BP

574 mg/ml
20 mg/ml
50 mg/ml

60

Arachis Oil BP
Paradichlorobenzene BP
Chlorbutanol BP

574 mg/ml
20 mg/ml
50 mg/ml

60

1,886 TAN 00,305 M01A UNI

Laboratories for Applied


Biology Ltd.
UNITED KINGDOM

Cerumol,Solution
Laboratories for Applied
Biology Ltd.
UNITED KINGDOM

Cerumol,Solution
Laboratories for Applied
Biology Ltd.
UNITED KINGDOM

Laboratories Sterop .S.A - BELGIUM


Fercayl,Solution
100 mg/2ml

60

Laboratories Sterop .S.A


BELGIUM

Quinine
Dihydrochloride,Injectable
Quinine Dihydrochloride Ph 600 mg/2ml
Solution

60

Laboratories Sterop .S.A


BELGIUM

36

Lekar Pharmaceuticals Ltd


INDIA

Eur

Registrant

Manufacturer

Cerumol,Solution

Iron Dextran equivalent to


Iron III BP

1,885 TAN 00,2206 P01B STE

Shelf life
month

Lekar Pharmaceuticals Ltd - INDIA


Dicloran,Gel

Methyl Salicylate BP
Oleum Lini BP
Levomenthol BP
Diclofenac Diethylamine BP

Page 295 of 584

10 %w/w
3 %w/w
5 w/w
1 %w/w

Human Medicinal Products


S/No:

Registration Number

1,887 TAN 00,305 M01A UNI

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,888 TAN 00,4219 A10A LIL

100 IU

24

Lilly France S.A.S


FRANCE

100 IU/ml

24

Lilly France S.A.S


FRANCE

100 IU

24

Lilly France S.A.S


FRANCE

100 IU/ml

24

Lilly France S.A.S


FRANCE

36

Lilly France S.A.S


FRANCE

Humulin N,Injection

Humulin Regular,Injection

Human Insulin Ph Eur

1,892 TAN 00,4400 L01B LIL

Lekar Pharmaceuticals Ltd


INDIA

Humalog,Injectable Solution

Human Insulin
(Recombinant DNA origin)
Ph Eur
1,891 TAN 00,4612 A10A LIL

36

Humulin N,Injectable Solution

Insulin Lispro IH

1,890 TAN 00,4219 A10A LIL

10 %w/w
3 %w/w
5 w/w
1 %w/w

Lilly France S.A.S - FRANCE


Human Insulin
(Recombinant DNA origin)
IH

1,889 TAN 00,2173 A10A LIL

Manufacturer

Dicloran,Gel

Methyl Salicylate BP
Oleum Lini BP
Levomenthol BP
Diclofenac Diethylamine BP

Registrant

Shelf life
month

Gemzar,Injectable Solution

Gemcitabine Hydrochloride 200 mg


IH

Page 296 of 584

Human Medicinal Products


S/No:

Registration Number

1,893 TAN 00,4401 L01B LIL

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,895 TAN 09,157 N02B LIN

1,896 TAN 00,2361 D01B LIN

1,897 TAN 00,4136 J03C LIN

1,898 TAN 00,4134 J01F LIN

36

Lilly France S.A.S


FRANCE

24

Lilly France S.A.S


FRANCE

Humulin N,Injectable Solution

Human Insulin Ph Eur

Registrant

Manufacturer

Gemzar,Injectable Solution

Gemcitabine Hydrochloride 1 g
IH

1,894 TAN 00,4613 A10A LIL

Shelf life
month

100 IU/ml

Lincoln Pharmaceuticals Ltd. - INDIA


Dolomol,Tablet

Paracetamol BP

500 mg

36

Ketoconazole USP

200 mg

36

Norfloxacin BP
Tinidazole BP

400 mg
600 mg

36

Roxithromycin BP

150 mg

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Konazol,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Norzole,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Roxilin,Tablet

Page 297 of 584

Lincoln Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,899 TAN 00,4135 J01K LIN

1,900 TAN 00,4137 J01K LIN

1,901 TAN 00,4299 J02A LIN

1,902 TAN 00,4365 A03B LIN

1,903 TAN 00,4364 R06A LIN

1,904 TAN 00,4402 A02B LIN

1,905 TAN 00,2006 P01B LIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Alps,Tablet

Sparfloxacin USP

200 mg

36

Ofloxacin USP

200 mg

36

Fluconazole IH

150 mg

36

Hyoscine Butylbromide BP

10 mg/ml

24

Promethazine Hydrochloride 25 mg/ml


BP

36

Omeprazole BP

20 mg

36

Amodiaquine BP

200 mg

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Toflox-200,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Flucan,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Spaslin H,Injection
Lincoln Pharmaceuticals
Ltd.
INDIA

Phenarzine,Injection
Lincoln Pharmaceuticals
Ltd.
INDIA

Omlink,Capsules
Lincoln Pharmaceuticals
Ltd.
INDIA

Amoquine,Tablet

Page 298 of 584

Lincoln Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,906 TAN 05,117 D04A LIN

1,907 TAN 05,116 P01A LIN

1,908 TAN 05,183 M01A LIN

1,909 TAN 00 1992 P01B LIN

1,910 TAN 05,669 V07A LIN

1,911 TAN 00,963 A02A LIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Abitol,Tablet

Cyproheptadine
Hydrochloride BP

4 mg

36

Secnidazole
Secnidazole IH

1000 mg

36

Ibuprofen BP
Paracetamol BP

400 mg
325 mg

36

Quinine Dihydrochloride
BP

300 mg/ml

36
month
s

Chlorpheniramine Maleate
BP
Dextromethorphan
Hydrobromide BP
Paracetamol BP
Phenylephrine
Hydrochloride BP

2 mg

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Sac,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Koflame,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Linquine F,Injectable Solution


Lincoln Pharmaceuticals
Ltd.
INDIA

Flucomol,Capsules

Compound Magnesium
Trisilicate,Tablet

15 mg
500 mg
10 mg

Dried Aluminium Hydroxide 120 mg


BP
250 mg
Magnesium Trisilicate BP

Page 299 of 584

Lincoln Pharmaceuticals
Ltd.
INDIA

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,912 TAN 06,078 M01A LIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,914 TAN 07,503 M01A LIN

1,915 TAN 07,339 R03A LIN

1,916 TAN 07,338 A10B LIN

1,917 TAN 07,504 D01A LIN

1,918 TAN 00,1999 J01A LIN

Manufacturer

Vivian Plus,Tablet

Diclofenac Sodium BP
Paracetamol BP

1,913 TAN 06,077 R03A LIN

Shelf life
month

50 mg
500 mg

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Dawakof,Syrup

Ambroxol Hydrochloride BP 15 mg
Salbutamol Sulphate
1 mg
equivalent to Salbutamol BP

36

Paracetamol BP
Dicyclomine BP

500 mg
20 mg

36

Aminophylline BP

100 mg

36

Glibenclamide BP

5 mg

36

Miconazole BP

2%

36

Tetracycline Hydrochloride
BP

250 mg

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Spaslim,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Aminophylline,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Diolin,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Micora,Gel
Lincoln Pharmaceuticals
Ltd.
INDIA

Teterous,Capsules

Page 300 of 584

Lincoln Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,919 TAN 00,1994 J01H LIN

1,920 TAN 00,1998 D01A LIN

1,921 TAN 00,2000 J03C LIN

1,922 TAN 00,2001 N02B LIN

1,923 TAN 00,2002 N02B LIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Ampicillin Sodium,Powder for


Injection

Ampicillin Sodium
equivalent to Ampicillin BP

500 mg

36

Clotrimazole BP

2 %w/w

36

Griseofulvin BP

500 mg

36

Diclofenac Sodium BP

50 mg

36

1,925 TAN 09,025 J02A LIN

Manufacturer

Lincoln Pharmaceuticals
Ltd.
INDIA

Clotrilin V,Cream
Lincoln Pharmaceuticals
Ltd.
INDIA

Dermofulvin,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Vivian,Tablet

Lignocaine,Injectable
Solution

lignocaine hydrochloride BP 20 mg/ml

1,924 TAN 00,4300 P01B LIN

Shelf life
month

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Lincoln Pharmaceuticals
Ltd.
INDIA

Quinine Sulphate,Tablet

Quinine Sulphate BP

300 mg

36

Ketoconazole USP

200 mg

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Konazol,Tablet

Page 301 of 584

Lincoln Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,926 TAN 09,286 J03C LIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,928 TAN 10,026 R02A LIN

1,929 TAN 05,117 D04A LIN

1,930 TAN 05,117 D04A LIN

1,931 TAN 10, 067 A10B

Manufacturer

Lomodex,Tablet

Lomefloxacin Hydrochloride 400 mg


IH

1,927 TAN 09,285 R03A LIN

Shelf life
month

Aminophylline,Injectable
Solution

36

Aminophylline BP

25 mg/ml

24

Bromhexine Hydrochloride
BP
Dextromethorphan
Hydrobromide BP
Levomenthol BP
Ammonium Chloride BP

8 mg

36

Cyproheptadine
Hydrochloride BP

4 mg

36

Cyproheptadine
Hydrochloride BP

4 mg

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Lincoln Pharmaceuticals
Ltd.
INDIA

Nam Syrup,Syrup

10 mg

Lincoln Pharmaceuticals
Ltd.
INDIA

5 mg
100 mg

Abitol,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Abitol,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

M - Forlin,Tablet

Metformin Hydrochloride BP 500 mg

Page 302 of 584

36

Elysium Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,932 TAN 10, 084 N02B LIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,935 TAN 05,183 M01A LIN

1,936 TAN 05,183 M01A LIN

1,937 TZ11H010

1,938 TAN 00,963 A02A LIN

36

Elysium Pharmaceuticals
Ltd.
INDIA

Diasix,Injectable Solution
10 mg/ml

36

Adrenaline BP

1 mg

12

Ibuprofen BP
Paracetamol BP

400 mg
325 mg

36

Ibuprofen BP
Paracetamol BP

400 mg
325 mg

36

Ketoconazole USP

2 %w/w

36

Furosemide BP

1,934 TAN 10, 082 V03A LIN

Manufacturer

Strom,Capsules

Tramadol Hydrochloride BP 50 mg

1,933 TAN 10, 083 C03C LIN

Shelf life
month

Lincoln Pharmaceuticals
Ltd.
INDIA

Adrenaline,Injectable Solution
Lincoln Pharmaceuticals
Ltd.
INDIA

Koflame,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Koflame,Tablet
Lincoln Pharmaceuticals
Ltd.
INDIA

Konazol,Cream

Compound Magnesium
Trisilicate,Tablet

Dried Aluminium Hydroxide 120 mg


BP
250 mg
Magnesium Trisilicate BP

Page 303 of 584

36

Lincoln Pharmaceuticals
Ltd.
INDIA

Lincoln Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

Registrant
1,939 TAN 09,158 J01D LUP

1,940 TAN 00,4403 J04A LUP

1,941 TAN 00,4404 J04A LUP

1,942 TAN 05,506 J04A LUP

1,943 TAN 05,507 J04A LUP

1,944 TAN 05,891 J04A LUP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Lupin Ltd. - INDIA


Cefaxone,Injectable Solution

Ceftriaxone USP

1g

24

Lupin Ltd.
INDIA

Ethambutol Hydrochloride
BP
Isoniazid BP

400 mg

24

Lupin Ltd.
INDIA

Isoniazid BP

300 mg

24

Lupin Ltd.
INDIA

Ethambutol Hydrochloride
BP

400 mg

60

Lupin Ltd.
INDIA

Isoniazid USP
Rifampicin USP

100 mg
150 mg

36

Lupin Ltd.
INDIA

Ethambutol Hydrochloride
USP
Isoniazid USP
Rifampicin USP

275 mg

24

Lupin Ltd.
INDIA

Combunex,Tablet

150 mg

Isoniazid,Tablet

Combutol,Tablet

Rifampicin + Isoniazid,Tablet

Akuri T-3,Tablet

Page 304 of 584

75 mg
150 mg

Human Medicinal Products


S/No:

Registration Number

1,945 TAN 06,182 B04A LUP

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,947 TAN 07,069 C01K LUP

1,948 TAN 07,070 J01D LUP

1,949 TAN 07,196 B04A LUP

1,950 TAN 07,340 C01E LUP

Registrant

Manufacturer

Tonact-20,Tablet
20 mg

24

Lupin Ltd.
INDIA

Diclofenac Sodium BP

25 mg/ml

36

Lupin Ltd.
INDIA

Atenolol BP

50 mg

24

Lupin Ltd.
INDIA

Cefalexin BP

500 mg

24

Lupin Ltd.
INDIA

Atorvastatin IH

10 mg

24

Lupin Ltd.
INDIA

Lisinopril USP

5 mg

24

Lupin Ltd.
INDIA

Atorvastatin IH

1,946 TAN 06,183 M01A LUP

Shelf life
month

Diclonac Injection,Injectable
Solution

Atenova 50,Tablet

Ceff 500,Capsules

Tonact-10,Tablet

Lipril,Tablet

M.J Biopharm Pvt Ltd. - INDIA

Page 305 of 584

Human Medicinal Products


S/No:

Registration Number

1,951 TAN 09,161 A10A M.J

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,954 TAN 09,162 J04A MAC

1,955 TAN 09,164 J01F MAC

1,956 TAN 05,778 A03B MAC

24

M.J Biopharm Pvt Ltd


INDIA

100 IU/ml

24

M.J Biopharm Pvt Ltd


INDIA

1g

24

M.J Biopharm Ltd.


INDIA

Monan,Injectable Solution

Moropenem USP

Registrant

100 IU/ml

Biosulin N,Injectable Solution

Human Insulin IH

1,953 TAN 09,160 J01K M.J

Manufacturer

Biosulin N,Injectable Solution

Human Insulin IH

1,952 TAN 09,159 A10A M.J

Shelf life
month

Macleods Pharmaceuticals Ltd. - INDIA


Forecox-Trac,Tablet
36

Ethambutol Hydrochloride
BP
Isoniazid BP
Pyrazinamide BP
Rifampicin BP

275 mg

Azithromycin Dihydrate
equivalent to Azithromycin
BP

500 mg

24

Hyoscine Butylbromide BP

10 mg

36

75 mg
400 mcg
150 mg

Macleods Pharmaceutical
Ltd.
INDIA

Azicure,Tablet
Macleods Pharmaceutical
Ltd.
INDIA

Oraspas,Tablet

Page 306 of 584

Macleods Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,957 TAN 06,311 C04A MAC

1,958 TAN 06,310 C04A MAC

1,959 TAN 07,073 MAC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Tadalafil IH

20 mg

24

Tadalafil IH

10 mg

24

1g

24

200 mg

36

250 mg

24

100 mg

24

300 mg

24

Macleods Pharmaceutical
Ltd.
INDIA

Oflomac-200,Tablet
Macleods Pharmaceutical
Ltd.
INDIA

Levomac 250,Tablet
Macleods Pharmaceutical
Ltd.
INDIA

Zidomac 100,Capsules

Zidovudine USP

1,963 TAN 07,078 J05A MAC

Macleods Pharmaceuticals
Ltd.
INDIA

Kanamac,Powder for Injection

Levofloxacin Hemihydrate
IH

1,962 TAN 07,072 J05A MAC

Macleods Pharmaceuticals
Ltd.
INDIA

Megalis-10,Tablet

Ofloxacin USP

1,961 TAN 07,077 J01K MAC

Manufacturer

Megalis-20,Tablet

Kanamycin Acid Sulphate


eq to Kanamycin BP

1,960 TAN 07,074 J01K MAC

Shelf life
month

Macleods Pharmaceutical
Ltd.
INDIA

Zidomac 300,Capsules

Zidovudine USP

Page 307 of 584

Macleods Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,964 TAN 07,071 J04A MAC

Product Name
Pack and Pack size

Ingredient(s) and Strength

75 mg
150 mg

36

100 mg

36

Chloramphenicol Sodium
Succinate equivalent to
Chloramphenicol IH

1g

36

Nevirapine USP

200 mg

36

Azithromycin Dihydrate
equivalent to Azithromycin
BP

250 mg

24

Ofloxacin USP

400 mg

24

400 mg

24

Primacort,Powder for
Injection

Hydrocortisone Sodium
Succinate eq to
Hydrocortisone IH

1,966 TAN 07,197 J01B MAC

1,967 TAN 07,200 J05A MAC

1,968 TAN 07,506 J01F MAC

1,969 TAN 07,507 J01K MAC

1,970 TAN 08,077 J04A MAC

Manufacturer

RH COM,Tablet

Isoniazid BP
Rifampicin BP

1,965 TAN 07,199 V07A MAC

Shelf life
month

Chloramphenicol,Powder for
Injection

Macleods Pharmaceutical
Ltd.
INDIA

Macleods Pharmaceutical
Ltd.
INDIA

Macleods Pharmaceutical
Ltd.
INDIA

Nevirapine,Tablet
Macleods Pharmaceutical
Ltd.
INDIA

Azicure,Tablet
Macleods Pharmaceutical
Ltd.
INDIA

Oflomac,Tablet
Macleods Pharmaceutical
Ltd.
INDIA

Pyrazinamide,Tablet

Pyrazinamide BP

Page 308 of 584

Macleods Pharmaceutical
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,971 TAN 08,145 V07A MAC

1,972 TAN 10,027 J04A MAC

1,973 TZ11H013

1,974 TZ11H020

1,975 TZ11H154

1,976 TZ11H155

1,977 TZ11H156

Product Name
Pack and Pack size

Ingredient(s) and Strength

Primacort,Powder for
Injection

Shelf life
month

Hydrocortisone Sodium
Succinate equivalent to
Hydrocortisone BP

200 mg

36

Ethambutol BP

400 mg

36

Ibuprofen BP

400 mg

36

Stavudine USP

30 mg

36

Lamivudine USP
Stavudine USP

150 mg
30 mg

24

Zidovudine USNF

300 mg

24

Lamivudine USP
Zidovudine USP

150 mg
300 mg

24

Manufacturer

Macleods Pharmaceutical
Ltd.
INDIA

Ecox - 400,Tablet
Macleods Pharmaceutical
Ltd.
INDIA

Ibuprofen,Tablet
Macleods Pharmaceutical
Ltd.
INDIA

Stavudine 30mg,Capsules

Lamivudine and
Stavudine,Tablet

Macleods Pharmaceuticals
Ltd.
INDIA

Macleods Pharmaceuticals
Ltd.
INDIA

Zidovudine 300mg,Tablet

Lamivudine and
Zidovudine,Tablet

Page 309 of 584

Macleods Pharmaceuticals
Ltd.
INDIA

Macleods Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

1,978 TZ11H157

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,979 D789

1,980 A959

1,981 B104

1,982 B105

1,983 E215

Manufacturer

Lamivudine 150mg,Tablet

Lamivudine USP

Registrant

Shelf life
month

150 mg

24

Macleods Pharmaceuticals
Ltd.
INDIA

Mansoor Daya Chemicals - TANZANIA


Aspirin,Tablet

Acetylsalicylic Acid BP

300 mg

24

Mansoor Daya Chemicals


TANZANIA

Chlorpheniramine Maleate
BP
Menthol BP

2 mg/5ml

36

Mansoor Daya Chemicals


TANZANIA

Boric Acid BP
Chlorinated Lime BP

0.625 %w/v
1.25 %w/v

48

Mansoor Daya Chemicals


TANZANIA

Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Hydrochloride BP
Cyanocobalamine BP
Riboflavin Sodium
Phosphate BP
Nicotinamide BP

2 mg/5ml

48

Mansoor Daya Chemicals


TANZANIA

Sediton,Syrup

0.0005 mg/5ml

Eusol,Solution

Emdeplex,Solution

9 mg/5ml
9 mcg/5ml
2.5 mg/5ml
20 mg/5ml

Mandal's Paint,Liquid

Iodine BP

375 mg

Page 310 of 584

Mansoor Daya Chemicals


TANZANIA

Human Medicinal Products


S/No:

Registration Number

1,984 A955

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,987 B101

120 mg/5ml

36

Mansoor Daya Chemicals


TANZANIA

2 mg/5ml

36

Mansoor Daya Chemicals


TANZANIA

36

Mansoor Daya Chemicals


TANZANIA

24

Mansoor Daya Chemicals


TANZANIA

Sediton Cough linctus,Syrup

Chlorpheniramine Maleate
BP
Guaiphenesin BP
Menthol BP
Ammonium Chloride BP
1,986 A958

Manufacturer

Endemol,Syrup

Paracetamol BP

1,985 A957

Shelf life
month

Junior Care Cough Cold


Formula,Syrup

100 mg/5ml
1 mg/5ml
100 mg/5ml

Chlorpheniramine Maleate
BP
Dextromethorphan
Hydrochloride IH
Pseudoephedrine
Hydrochloride BP

0.04 %w/v

Thiamine Hydrochloride IH
Ascorbic Acid IH
Vitamin A IH
Cyanocobalamine IH
Cholecalciferol IH
Riboflavin Sodium
Phosphate IH
Nicotinamide IH
Pyridoxine Hydrochloride
Ascorbic Acid IH
Tocopheryl Acetate
Nicotinamide
Dexapanthenol IH

4.5 mg/3ml
140 mg/10ml
4000 IU/10ml
0.02 mg/10ml
400 IU/10ml
2.4 mg/10ml

0.1 %w/v
0.6 %w/v

Emdevite,Solution

Page 311 of 584

18 mg/10ml
2 mg/10ml
3 mg/10ml

Human Medicinal Products


S/No:

Registration Number

1,988 B102

Product Name
Pack and Pack size

Ingredient(s) and Strength

1,990 D786

1,991 D788

Ephedryn nasal drops


0.5%,Drops

1,993 D791

1,994 D792

36

Mansoor Daya Chemicals


TANZANIA

Ephedrine Hydrochloride
BP

0.5 %w/v

24

Mansoor Daya Chemicals


Ltd

Boric Acid BP

6%

36

Mansoor Daya Chemicals


TANZANIA

24

Mansoor Daya Chemicals


TANZANIA

Borax,Drops

Salbutamol,Syrup

Salbutamol Sulphate
2 mg
equivalent to Salbutamol BP

1,992 D790

Manufacturer

Allerzine,Elixir

Promethazine Hydrochloride 0.1 %w/v


BP

1,989 D785

Shelf life
month

Co Trimoxazole,Syrup

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

36

Mansoor Daya Chemicals


TANZANIA

Paracetamol BP

500 mg

24

Mansoor Daya Chemicals


TANZANIA

10 mg
150 mg

36

Mansoor Daya Chemicals


TANZANIA

Paracetamol,Tablet

Mist Carminative,Liquid

Sodium Carbonate BP
Magnesium Carbonate BP

Page 312 of 584

Human Medicinal Products


S/No:

Registration Number

1,995 D793

1,996 D794

1,997 D795

1,998 D798

1,999 D800

2,000 D801

Product Name
Pack and Pack size
Chlorpheniramine
Maleate,Tablet

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Chlorpheniramine Maleate
BP

4 mg

36

Mansoor Daya Chemicals


TANZANIA

Codeine Phosphate BP
Sodium Citrate BP
Diphenhydramine BP
Ammonium Chloride BP

5
5
5
5

mg
mg
mg
mg

24

Mansoor Daya Chemicals


TANZANIA

Sodium Citrate BP
Diphenhydramine BP
Ammonium Chloride BP

5 mg
5 mg
5 mg

24

Mansoor Daya Chemicals


TANZANIA

Folic Acid BP

5 mg

24

Mansoor Daya Chemicals


TANZANIA

Folic Acid BP
Ferric Ammonium Citrate
BP
Cyanocobalamine BP

5 mg
5 mg

24

Mansoor Daya Chemicals


TANZANIA

Ferric Ammonium Citrate


BP
Thiamine BP
Nicotinamide BP
Riboflavin BP

5 mg

24

Mansoor Daya Chemicals


TANZANIA

Emdelyn,Syrup

Emdelyn,Syrup

Folic Acid,Tablet

Hematone,Syrup

5 mg

Emdee,Solution

Page 313 of 584

5 mg
5 mg
5 mg

Human Medicinal Products


S/No:

Registration Number

2,001 D802

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,003 D804

2,004 D805

2,005 D806

400 mg
80 mg

24

Mansoor Daya Chemicals


TANZANIA

Ephedrine Hydrochloride
BP

1%

24

Mansoor Daya Chemicals


TANZANIA

Phenol BP

5 mg

24

Mansoor Daya Chemicals


TANZANIA

Camphor oil BP
Almond Oil BP
Arachis Oil BP

5 mg
5 mg
5 mg

24

Mansoor Daya Chemicals


TANZANIA

5 mg

24

Mansoor Daya Chemicals


TANZANIA

5 mg

24

Mansoor Daya Chemicals


TANZANIA

5 mg

24

Mansoor Daya Chemicals


TANZANIA

Epheryn,Nasal Drops

Glycerine,Solution

Emdewax,Solution

Tincture Iodine,Solution

Iodine BP

2,006 D807

Mist Pot Cit,Solution

Potassium Citrate BP

2,007 D808

Manufacturer

Co -Trimoxazole,Tablet

Sulfamethoxazole BP
Trimethoprim BP

2,002 D803

Shelf life
month

Sodium Bicarbonate,Ear
Drops

Sodium Bicarbonate BP

Page 314 of 584

Human Medicinal Products


S/No:

Registration Number

2,008 D809

Product Name
Pack and Pack size

Ingredient(s) and Strength

5 mg
5 mg
5 mg

24

Mansoor Daya Chemicals


TANZANIA

6%

24

Mansoor Daya Chemicals


TANZANIA

100 %

24

Mansoor Daya Chemicals


TANZANIA

Gentian Violet BP

0.5 %

24

Mansoor Daya Chemicals


TANZANIA

Acriflavine Hydrochloride
BP

0.1 g/100ml

24

Mansoor Daya Chemicals


TANZANIA

100 %

24

Mansoor Daya Chemicals


TANZANIA

Hydrogen Peroxide,Solution

Hydrogen Peroxide BP

2,010 E216

Liquid paraffin,Liquid

Liquid Paraffin BP

2,011 E217

2,012 E218

2,013 E220

Gentian Violet,Liquid

Acriflavine,Liquid

Pure Glycerine,Liquid

Glycerine BP

2,014 E221

Manufacturer

Mist Kaolin,Liquid

Sodium Bicarbonate BP
Magnesium Carbonate BP
Kaolin Light BP
2,009 D810

Shelf life
month

Sedikof,Syrup

Page 315 of 584

Human Medicinal Products


S/No:

Registration Number

2,015 E222

2,016 E223

2,017 E224

Product Name
Pack and Pack size

Ingredient(s) and Strength

Mansoor Daya Chemicals


TANZANIA

25 g/5ml

24

Mansoor Daya Chemicals


TANZANIA

15 mg/5ml

24

Mansoor Daya Chemicals


TANZANIA

14 mg/5ml

24

Mansoor Daya Chemicals


TANZANIA

0.1 g/dosage unit

24

Mansoor Daya Chemicals


TANZANIA

15 mg/5ml

24

Mansoor Daya Chemicals


TANZANIA

100 mg/5ml
6.5 mg/5ml

Benzyl benzoate BP

Dextromethorphan
Hydrobromide USP

14 mg/5ml
30 mg/5ml

BBE,Emulsion

Emdelyn DM,Syrup

Emdelyn
Expectorant,Expectorant

Potassium
Permanganate,Liquid

Potassium Permanganate
BP

2,019 E226

Manufacturer

24

Guaiphenesin BP
Dextromethorphan
Hydrobromide USP
Diphenhydramine
Hydrochloride USP
Pseudoephedrine
Hydrobromide USP

Diphenhydramine
Hydrochloride BP
Sodium Citrate BP
Ammonium Chloride BP

2,018 E225

Shelf life
month

54 mg/5ml
130 mg/5ml

Codeine Linctus,Liquid

Codeine Phosphate BP

Page 316 of 584

Human Medicinal Products


S/No:

Registration Number

2,020 E227

Product Name
Pack and Pack size

Ingredient(s) and Strength

25 %w/w

24

Mansoor Daya Chemicals


TANZANIA

3 %v/v

24

Mansoor Daya Chemicals


TANZANIA

3 g/5ml
1.5 g/5ml

24

Mansoor Daya Chemicals


TANZANIA

Piperazine Citrate BP

750 mg/5ml

24

Mansoor Daya Chemicals


TANZANIA

Benzoin tincture BP

100 %v/v

24

Mansoor Daya Chemicals


TANZANIA

Benzoic Acid BP
Salicylic Acid BP

1.8 g/ml
0.9 g/5ml

24

Mansoor Daya Chemicals


TANZANIA

5 mg
5 mg
5 mg

24

Mansoor Daya Chemicals


TANZANIA

Paediatric Belladona,Liquid

Tincture Belladona BP

2,022 E229

Whitfield Ointment,Ointment

Benzoic Acid BP
Salicylic Acid BP

2,023 E230

2,024 E231

2,025 E219

2,026 D797

Manufacturer

Liniment Alba,Lotion

Turpentine Oil BP

2,021 E228

Shelf life
month

Antiworm Elixir,Liquid

Tincture Benzoin
Compound,Liquid

Mycoderm,Lotion

Vitamin B Complex,Tablet

Thiamine BP
Riboflavin BP
Nicotinamide Ph Eur

Page 317 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
2,027 TAN 07,079 B05X MAR

2,028 TZ10H101

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,029 TAN 00,1879 B05B MAR

2,030 TAN 00,1876 B05B MAR

2,031 TAN 00,1877 B05B MAR

2,032 TAN 00,1878 B05B MAR

Manufacturer

Marck Biosciences Ltd. - INDIA


Sterilised water for
injection,Liquid

Water for Injection BP

NA N/A

36

Marck Biosciences Ltd.


INDIA

0.3 %w/v

24

MURZAH OIL MILLS (T) LTD


TANZANIA

Xcipro,Ear/Eye Drops

Ciprofloxacin USP

Registrant

Shelf life
month

Marck Parenterals (India) Ltd. - INDIA


Sodium Chloride +
Glucose,Solution

Glucose Anhydrous BP
Sodium Chloride BP

50 g/L
9 g/L

36

Glucose Anhydrous BP

50 g/L

60

Calcium Chloride BP
Sodium Chloride BP
Potassium Chloride BP
Sodium Lactate USP

0.27 g/L
6 g/L
0.4 g/L
3.2 g/L

60

9 g/L

36

Marck Parenterals (India)


Ltd.
INDIA

Glucose,Solution

Compound Sodium
Lactate,Solution

Marck Parenterals (India)


Ltd.
INDIA

Marck Parenterals (India)


Ltd.
INDIA

Sodium Chloride,Solution

Sodium Chloride BP

Page 318 of 584

Marck Parenterals (India)


Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

2,033 TAN 00,2175 P01X MAR

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,035 TAN 00,4145 J02A MAR

2,036 TAN 00,4144 B05B MAR

2,037 TAN 00,4143 B05B MAR

2,038 TAN 00,4140 B05B MAR

2,039 TAN 00,4142 B05B MAR

Manufacturer

Metronidazole,Solution
5 mg/ml

24

Ciprofloxacin USP

200 mg/100ml

24

Fluconazole IH
Sodium Chloride BP

200 mg/100ml
0.9 g/100ml

36

Calcium Chloride BP
Sodium Lactate BP
Potassium Chloride BP
Sodium Chloride USP

0.27 g/L
6 g/L
0.4 g/L
3.2 g/L

36

Glucose Anhydrous BP

50 g/L

36

Glucose BP

100 g/L

36

Mannitol BP

200 g/L

36

Metronidazole BP

2,034 TAN 00,2174 J01K MAR

Shelf life
month

Marck Parenterals (India)


Ltd.
INDIA

Ciprofloxacin,Solution
Marck Parenterals (India)
Ltd.
INDIA

Candican,Solution
Marck Parenterals (India)
Ltd.
INDIA

Ringer Lactate,Solution
Marck Parenterals (India)
Ltd.
INDIA

Glucose,Solution
Marck Parenterals (India)
Ltd.
INDIA

Glucose,Solution
Marck Parenterals (India)
Ltd.
INDIA

Mannitol,Solution

Page 319 of 584

Marck Parenterals (India)


Limited
INDIA

Human Medicinal Products


S/No:

Registration Number

2,040 TAN 00,4477 B05B MAR

2,041 TAN 05,508 B05B MAR

2,042 TAN 00,1879 B05B MAR

2,043 TAN 00,1879 B05B MAR

2,044 TAN 00,1877 B05B MAR

2,045 TAN 00,1878 B05B MAR

Product Name
Pack and Pack size
Sodium Chloride +
Glucose,Solution

Ingredient(s) and Strength

50 g/100ml
9 g/100ml

36

Sodium Chloride BP

0.9 g/100ml

36

Glucose Anhydrous BP
Sodium Chloride BP

50 g/L
9 g/L

36

Glucose Anhydrous BP
Sodium Chloride BP

50 g/L
9 g/L

36

Calcium Chloride BP
Sodium Chloride BP
Potassium Chloride BP
Sodium Lactate USP

0.27 g/L
6 g/L
0.4 g/L
3.2 g/L

60

0.9 g/L

60

5 mg/ml

24

Glucose Anhydrous BP
Sodium Chloride BP

Manufacturer

Marck Parenterals (India)


Ltd.
INDIA

Sodium Chloride,Solution

Sodium Chloride +
Glucose,Solution

Sodium Chloride +
Glucose,Solution

Compound Sodium
Lactate,Solution

Marck Parenterals (India)


Ltd.
INDIA

Marck Parenterals (India)


Ltd.
INDIA

Marck Parenterals (India)


Ltd.
INDIA

Marck Parenterals (India)


Ltd.
INDIA

Sodium Chloride,Solution

Sodium Chloride BP

2,046 TAN 00,2175 P01X MAR

Shelf life
month

Marck Parenterals (India)


Ltd.
INDIA

Metronidazole,Solution

Metronidazole BP

Page 320 of 584

Marck Parenterals (India)


Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

2,047 TAN 00,2174 J01K MAR

2,048 TAN 00,4145 J02A MAR

2,049 TAN 00,4144 B05B MAR

2,050 TAN 00,4143 B05B MAR

2,051 TAN 00,4140 B05B MAR

2,052 TAN 00,4142 B05B MAR

2,053 TAN 00,4477 B05B MAR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Ciprofloxacin,Solution

Ciprofloxacin USP

200 mg/100ml

24

Fluconazole IH
Sodium Chloride BP

200 mg/100ml
0.9 g/100ml

36

Calcium Chloride BP
Sodium Lactate BP
Potassium Chloride BP
Sodium Chloride USP

0.27 g/L
6 g/L
0.4 g/L
3.2 g/L

36

Glucose Anhydrous BP

50 g/L

36

Glucose BP

100 g/L

36

Mannitol BP

200 g/L

36

Glucose Anhydrous BP
Sodium Chloride BP

50 g/100ml
9 g/100ml

36

Marck Parenterals (India)


Ltd.
INDIA

Candican,Solution
Marck Parenterals (India)
Ltd.
INDIA

Ringer Lactate,Solution
Marck Parenterals (India)
Ltd.
INDIA

Glucose,Solution
Marck Parenterals (India)
Ltd.
INDIA

Glucose,Solution
Marck Parenterals (India)
Ltd.
INDIA

Mannitol,Solution

Sodium Chloride +
Glucose,Solution

Page 321 of 584

Marck Parenterals (India)


Limited
INDIA

Marck Parenterals (India)


Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

Registrant
2,054 TAN 00,4220 N02B MAR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Pethidine,Injectable Solution

2,056 TAN 08,017 J05A MAT

Registrant
2,058 TAN 05,184 A11A MED

36

Martindale Pharmaceuticals
Ltd
UNITED KINGDOM

Stavudine,Capsules
30 mg

Lamivudune/Nevirapine/Zido
vudine,Tablet

24

Matrix Laboratories Ltd


INDIA

24

Matrix Laboratories Ltd


INDIA

24

Medicap Ltd.
THAILAND

Medicap Ltd. - THAILAND


Ferrotone,Capsules

Ferrous Fumarate BP
Cyanocobalamine IH
Folic Acid USP
2,059 TAN 05,185 A16A MED

Martindale Pharmaceuticals
Ltd
UNITED KINGDOM

Matrix Laboratories Ltd. - INDIA


Stavudine USP

2,057 TAN 10, 028 J05A MAT

36

Pethidine,Injectable Solution

Pethidine Hydrochloride BP 50 mg/ml

Registrant

Manufacturer

Martindale Pharmaceuticals Ltd - UNITED KINGDOM


Pethidine Hydrochloride BP 100 mg/2ml

2,055 TAN 00,4221 N02B MAR

Shelf life
month

Vitacap,Capsules

Page 322 of 584

162 mg
7.5 mcg
0.75 mg

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Ferrous Fumarate BP
Cholecalciferol BP
Vitamin A Palmitate BP
Tocopherol IH
Cyanocobalamin (Vitamin
B12) IH
Thiamine Mononitrate USP
Ascorbic Acid USP
Folic Acid USP
Manganese Sulphate
Monohydrate USP
Magnesium Oxide USP
Riboflavine USP
Dibasic Calcium Phosphate
Anhydrous USP
Potasium Iodide USP
Nicotinamide USP
D-Panthenol USP
Copper Sulfate
Pentahydrate USP
Zinc sulphate monohydrate
USP
Pyridoxine Hydrochloride
Ascorbic Acid USP

Registrant
2,060 TAN 05,037 V03A MED

2,061 TAN 05,035 B05B MED

50 mg
400 IU
5000 IU
15 mg
5 mcg

Shelf life
month

Manufacturer

24

Medicap Ltd.
THAILAND

5 mg
75 mg
1.1 mg
0.01 mg
0.5 mg
5 mg
70 mg
0.025 mg
45 mg
7.5 mg
0.1 mg
55.57 mg
2.2 mg

Medipak Ltd. - PAKISTAN


Medisol S,Solution

Dextrose BP
Sodium Chloride BP

5 %w/v
0.9 %w/v

48

Medipak Ltd.
PAKISTAN

Dextrose Monohydrate BP

5 %w/v

48

Medipak Ltd.
PAKISTAN

Medisol,Solution

Page 323 of 584

Human Medicinal Products


S/No:

Registration Number

2,062 TAN 05,038 B05B MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

0.9 %w/v

24

Medipak Ltd.
PAKISTAN

555 mg/g

36

Medipak Ltd.
PAKISTAN

Ciprofloxacin Hydrochloride 0.3 %w/v


USP

24

Medipak Ltd.
PAKISTAN

0.5 %

36

Medipak Ltd.
PAKISTAN

5 mg/ml
1.32 mg/ml

24

Medipak Ltd.
PAKISTAN

1.32 mg/ml

24

Medipak Ltd.
PAKISTAN

Aqua Steril,Solution

Water for Injection BP

2,064 TAN 07,341 J01K MED

2,065 TAN 09,027 S01D MED

Ciprofena,Ophthalmic
Solution

Meditim,Ophthalmic Solution

Timolol Maleate USP

2,066 TAN 09,026 J01B MED

Medidex-C,Ophthalmic
Solution

Chloramphenicol USP
Dexamethasone Sodium
Phosphate USP

2,067 TAN 09,050 H02A MED

Medidex,Ophthalmic Solution

Dexamethasone Sodium
Phosphate USP

Registrant

Manufacturer

Medisol N S,Solution

Sodium Chloride BP

2,063 TAN 05,036 V07A MED

Shelf life
month

Medley Pharmaceuticals Ltd. - INDIA

Page 324 of 584

Human Medicinal Products


S/No:

Registration Number

2,068 TAN 09,172 C01K MED

2,069 TAN 09,173 C01K MED

2,070 TAN 09,174 J01K MED

2,071 TAN 05,039 J01D MED

2,072 TAN 06,079 M01A MED

2,073 TAN 06,314 B04A MED

2,074 TAN 06,315 C01K MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Primodil-5,Tablet

Amlodipine Besylate BP

5 mg

24

Amlodipine Besylate BP

10 mg

24

Medley Pharmaceuticals
Ltd.
INDIA

Primodil-10,Tablet
Medley Pharmaceuticals
Ltd.
INDIA

Ecoflox 500,Tablet

Ciprofloxacin Hydrochloride 500 mg


BP

36

Cefuroxime Axetil
equivalent to Cefuroxime
USP

250 mg

18

Aceclofenac BP

100 mg

24

Atorvastatin Calcium IH

10 mg

24

50 mg

36

Medley Pharmaceuticals
Ltd.
INDIA

Ceurox,Tablet
Medley Pharmaceuticals
Ltd.
INDIA

Acenac,Tablet
Medley Pharmaceuticals
Ltd.
INDIA

Atorin-10,Tablet
Medley Pharmaceuticals
Ltd.
INDIA

B.P. Norm-50,Tablet

Atenolol BP

Page 325 of 584

Medley Pharmaceuticals
Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

2,075 TAN 06,419 J01K MED

2,076 TAN 10,035 R06A MED

2,077 TAN 06,079 M01A MED

2,078 TAN 06,079 M01A MED

Registrant
2,079 TAN 00,1130 M01A MDC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Ofoxin-200,Tablet
Medley Pharmaceuticals
Ltd.
INDIA

Ofloxacin BP

200 mg

24

Caffeine Anhydrous BP
Chlorpheniramine Maleate
BP
Paracetamol BP
Phenylephrine
Hydrochloride BP

15 mg
2.0 mg

48

Aceclofenac BP

100 mg

24

Aceclofenac BP

100 mg

24

50 mg

60

Medochemie Ltd.
CYPRUS

2.5 mg

60

Medochemie Ltd.
CYPRUS

Coldrid,Tablet
Medley Pharmaceuticals
Ltd.
INDIA

500 mg
5 mg

Acenac,Tablet
Medley Pharmaceuticals
Ltd.
INDIA

Acenac,Tablet
Medley Pharmaceuticals
Ltd.
INDIA

Medochemie Ltd. - CYPRUS


Almiral,Tablet

Diclofenac Sodium Ph Eur

2,080 TAN 00,1131 N03A MDC

Shelf life
month

Medocriptine,Tablet

Bromocriptine Mesylate Ph
Eur

Page 326 of 584

Human Medicinal Products


S/No:

Registration Number

2,081 TAN 00,1133 G02C MDC

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,083 TAN 00,1638 J01D MDC

50 mg

60

Medochemie Ltd.
CYPRUS

Tramadol Hydrochloride Ph 50 mg
Eur

60

Medochemie Ltd.
CYPRUS

48

Medochemie Ltd.
CYPRUS

Mabron,Capsules

Medomycin,Capsules

Doxycycline Hyclate Ph Eur 100 mg

2,084 TAN 00,1640 J02A MDC

2,085 TAN 00,1881 J01A MDC

2,086 TAN 00,4223 J01K MED

2,087 TAN 00,4235 M01A MED

Manufacturer

Duinum,Tablet

Clomifene Citrate Ph Eur

2,082 TAN 00,1447 N02B MDC

Shelf life
month

Medoflucon,Capsules

Fluconazole Ph Eur

150 mg

36

Medochemie Ltd.
CYPRUS

Acyclovir Ph Eur

200 mg

60

Medochemie Ltd.
CYPRUS

Ciprofloxacin Hydrochloride 500 mg


Ph Eur

36

Medochemie Ltd.
CYPRUS

Meloxicam BP

24

Medochemie Ltd.
CYPRUS

Medovir,Tablet

Medociprin,Tablet

Melox,Tablet

Page 327 of 584

7.5 mg

Human Medicinal Products


S/No:

Registration Number

2,088 TAN 00,4224 R06A MED

2,089 TAN 00,4303 C01E MED

2,090 TAN 00,4304 C01E MED

2,091 TAN 00,4308 C01E MED

2,092 TAN 00,4305 J01D MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,094 TAN 00,4233 M01A MED

Manufacturer

Tenerel,Tablet

Ketotifen Hydrogen
Fumarate equivalent to
Ketotifen Ph Eur

1 mg

60

Medochemie Ltd.
CYPRUS

Lisinopril Dihydrate
equivalent to Lisinopril Ph
Eur

20 mg

48

Medochemie Ltd.
CYPRUS

Lisinopril Dihydrate
equivalent to Lisinopril Ph
Eur

10 mg

48

Medochemie Ltd.
CYPRUS

Lisinopril Dihydrate
equivalent to Lisinopril Ph
Eur

5 mg

48

Medochemie Ltd.
CYPRUS

24

Medochemie Ltd.
CYPRUS

Ceftriaxone Sodium
1g
equivalent to Ceftriaxone Ph
Eur

24

Medochemie Ltd.
CYPRUS

Meloxicam BP

24

Medochemie Ltd.
CYPRUS

Dapril,Tablet

Dapril,Tablet

Dapril,Tablet

Medaxone,Powder for
Injection

Ceftriaxone Sodium
500 mg
equivalent to Ceftriaxone Ph
Eur

2,093 TAN 00,4302 J01D MED

Shelf life
month

Medaxone,Powder for
Injection

Melox,Tablet

Page 328 of 584

15 mg

Human Medicinal Products


S/No:

Registration Number

2,095 TAN 00,4233 M01A MED

2,096 TAN 00,4307 C01E MED

2,097 TAN 00,2010 A07D MDC

2,098 TAN 05,636 J01C COD

2,099 TAN 05,635 J01C COD

2,100 TAN 05,633 C01E COD

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Melox,Tablet

Meloxicam BP

15 mg

24

Medochemie Ltd.
CYPRUS

Captopril Ph Eur

25 mg

60

Medochemie Ltd.
CYPRUS

Loperamide Hydrochloride
Ph Eur

2 mg

60

Medochemie Ltd.
CYPRUS

125 mg
Clavulanic Acid Ph Eur
Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin Ph
Eur

24

Medochemie Ltd.
CYPRUS

Clavulanate Potassium Ph 125 mg


Eur
Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

24

Medochemie Ltd.
CYPRUS

Lisinopril Dihydrate
equivalent to Lisinopril Ph
Eur

24

Medochemie Ltd.
CYPRUS

Rilcapton,Tablet

Vacontil,Capsules

Syntoclav,Tablet

Syntoclav,Tablet

Albigone,Tablet

Page 329 of 584

20 mg

Human Medicinal Products


S/No:

Registration Number

2,101 TAN 05,632 J01F COD

2,102 TAN 05,631 C01K COD

2,103 TAN 05,629 P02A COD

2,104 TAN 05,630 N02B COD

2,105 TAN 05,784 J01D MED

2,106 TAN 05,780 J01D MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Codacin,Tablet

Erythromycin Stearate eq to 250 mg


Erythromycin Ph Eur

24

Medochemie Ltd.
CYPRUS

Atenolol Ph Eur

100 mg

24

Medochemie Ltd.
CYPRUS

Prazinquatel Ph Eur

600 mg

24

Medochemie Ltd.
CYPRUS

Tramadol Hydrochloride Ph 50 mg
Eur

24

Medochemie Ltd.
CYPRUS

Ceftriaxone Sodium
250 mg/vial
equivalent to Ceftriaxone Ph
Eur

24

Medochemie Ltd.
CYPRUS

24

Medochemie Ltd.
CYPRUS

24

Medochemie Ltd.
CYPRUS

Codanol,Tablet

Prazi,Tablet

Rofy,Capsules

Medaxone,Powder

Axetine,Powder for Injection

Cefuroxime Sodium
1.5 g
equivalent to Cefuroxime Ph
Eur
2,107 TAN 05,783 J01D MED

Shelf life
month

Axetine,Powder for Injection

Cefuroxime Sodium
250 mg/vial
equivalent to Cefuroxime Ph
Eur

Page 330 of 584

Human Medicinal Products


S/No:

Registration Number

2,108 TAN 05,782 J01D MED

2,109 TAN 05,779 J01D MED

2,110 TAN 05,781 J01D MED

2,111 TAN 05,785 J01D MED

2,112 TAN 06,041 A02B COD

2,113 TAN 06,038 A02B COD

2,114 TAN 06,040 J01H COD

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Valoran,Powder

Cefotaxime Sodium
1 g/10ml
Equivalent to Cefotaxime Ph
Eur

24

Medochemie Ltd.
CYPRUS

Cefotaxime Sodium
500 mg
Equivalent to Cefotaxime Ph
Eur

24

Medochemie Ltd.
CYPRUS

Cefazolin Sodium
1g
equivalent Cefazolin Ph Eur

30

Medochemie Ltd.
CYPRUS

Cefazolin Sodium
500 mg
equivalent Cefazolin Ph Eur

30

Medochemie Ltd.
CYPRUS

Cimetidine USP

20 mg

24

Medochemie Ltd.
CYPRUS

Cimetidine USP

400 mg

24

Medochemie Ltd.
CYPRUS

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

24

Medochemie Ltd.
CYPRUS

Valoran,Powder

Zepilen,Powder

Zepilen,Powder

Arbat,Tablet

Arbat,Tablet

Moxarin,Capsules

Page 331 of 584

Human Medicinal Products


S/No:

Registration Number

2,115 TAN 06,039 J01H COD

2,116 TAN 06,274 C01E COD

2,117 TAN 00,2010 A07D MDC

2,118 TAN 00,2010 A07D MDC

Registrant
2,119 TAN 00,4565 M01A MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Moxarin,Capsules

Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin Ph
Eur

24

Medochemie Ltd.
CYPRUS

Lisinopril Dihydrate
equivalent to Lisinopril Ph
Eur

5 mg

24

Medochemie Ltd.
CYPRUS

Loperamide Hydrochloride
Ph Eur

2 mg

60

Medochemie Ltd.
CYPRUS

Loperamide Hydrochloride
Ph Eur

2 mg

60

Medochemie Ltd.
CYPRUS

50 mg

36

Medopharm
INDIA

36

Medopharm
INDIA

Albigone,Tablet

Vacontil,Capsules

Vacontil,Capsules

Medopharm Private Ltd - INDIA


Diclofenac,Tablet

Diclofenac Sodium BP

2,120 TAN 00,4564 J01F MED

Shelf life
month

Erythromycin Stearate,Tablet

Erythromycin Stearate eq to 250 mg


Erythromycin NA

Page 332 of 584

Human Medicinal Products


S/No:

Registration Number

2,121 TAN 00,4310 A02A MED

2,122 TAN 00,4366 N02B MED

2,123 TAN 00,4367 P02X MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

Compound Magnesium
Trisilicate,Tablet

2,125 TAN 00,4369 B03A MED

2,126 TAN 00,4405 P01B MED

2,127 TAN 00,4419 J03B MED

Manufacturer

Magnesium Trisilicate BP
Aluminium Hydroxide BP
Aluminium Hdroxide Gel
equivalent to Aluminium
Hydroxide BP

250 mg
125 mg
125 mg

36

Medopharm
INDIA

Paracetamol BP

500 mg

36

Medopharm
INDIA

100 mg

36

Medopharm
INDIA

Chlorpheniramine Maleate
BP

4 mg

36

Medopharm
INDIA

Folic Acid BP

5 mg

36

Medopharm
INDIA

Sulfadoxine USP
Pyrimethamine USP

500 mg
25 mg

36

Medopharm
INDIA

400 mg
80 mg

36

Medopharm
INDIA

Paracetamol,Tablet

Mebendazole,Tablet

Mebendazole USP

2,124 TAN 00,4368 R06A MED

Shelf life
month

Chlorpheniramine,Tablet

Folic Acid,Tablet

Pyrimethamine +
Sulfadoxine,Tablet

Co Trimoxazole,Tablet

Sulfamethoxazole BP
Trimethoprim BP

Page 333 of 584

Human Medicinal Products


S/No:

Registration Number

2,128 TAN 00,4566 P01A MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,130 TAN 00,4433 A02B MED

2,131 TAN 00,4432 J01K MED

2,132 TAN 00,4431 N04A MED

2,133 TAN 00,4430 N04A MED

2,134 TAN 00,4429 A10B MED

Manufacturer

Metronidazole,Tablet
250 mg

36

Medopharm
INDIA

Metronidazole BP

250 mg

36

Medopharm
INDIA

Cimetidine USP

400 mg

36

Medopharm
INDIA

Ciprofloxacin Hydrochloride 500 mg


USP

36

Medopharm
INDIA

Metronidazole BP

2,129 TAN 00,4566 P01A MED

Shelf life
month

Metronidazole,Tablet

Cimetidine,Tablet

Ciprofloxacin,Tablet

Chlorpromazine,Tablet

Chlorpromazine
Hydrochloride BP

25 mg

36

Medopharm
INDIA

Haloperidol BP

1.5 mg

36

Medopharm
INDIA

250 mg

36

Medopharm
INDIA

Haloperidol,Tablet

Chlorpropamide,Tablet

Chlorpropamide BP

Page 334 of 584

Human Medicinal Products


S/No:

Registration Number

2,135 TAN 00,4428 A03B MED

2,136 TAN 00,4427 H04A MED

2,137 TAN 00,4426 C03C MED

2,138 TAN 00,4425 P02X MED

2,139 TAN 00,4424 R06A MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,141 TAN 00,4565 M01A MED

Manufacturer

Hyoscine Butylbromide,Tablet

Hyoscine Butylbromide BP

10 mg

36

Medopharm
INDIA

Tolbutamide BP

500 mg

36

Medopharm
INDIA

Frusemide BP

40 mg

36

Medopharm
INDIA

Albendazole USP

200 mg

36

Medopharm
INDIA

36

Medopharm
INDIA

Tolbutamide,Tablet

Furosemide,Tablet

Albendazole,Tablet

Promethazine,Tablet

Promethazine Hydrochloride 25 mg
BP

2,140 TAN 00,4423 R03A MED

Shelf life
month

Ephedrine
Hydrochloride,Tablet

Ephedrine Hydrochloride
BP

30 mg

36

Medopharm
INDIA

Diclofenac Sodium BP

50

36

Medopharm
INDIA

Diclofenac,Tablet

Page 335 of 584

Human Medicinal Products


S/No:

Registration Number

2,142 TAN 00,4565 M01A MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

36

Medopharm
INDIA

36

Medopharm
INDIA

Erythromycin Stearate eq to 250


Erythromycin NA

36

Medopharm
INDIA

Ibuprofen BP

200 mg

36

Medopharm
INDIA

Methyldopa BP

200 mg

36

Medopharm
INDIA

Phenytoin Sodium BP

100 mg

36

Medopharm
INDIA

200 mg

36

Medopharm
INDIA

50

Erythromycin Stearate,Tablet

Erythromycin Stearate eq to 250


Erythromycin NA

2,144 TAN 00,4564 J01F MED

2,145 TAN 05,186 M01A MED

2,146 TAN 05,512 C01K MED

2,147 TAN 05,509 N03A MED

2,148 TAN 05,511 N03A MED

Manufacturer

Diclofenac,Tablet

Diclofenac Sodium BP

2,143 TAN 00,4564 J01F MED

Shelf life
month

Erythromycin Stearate,Tablet

Ibuprofen,Tablet

Methyldopa,Tablet

Phenytoin,Tablet

Carbamazepine,Tablet

Carbamazepine BP

Page 336 of 584

Human Medicinal Products


S/No:

Registration Number

2,149 TAN 05,510 M01A MED

2,150 TAN 05,670 N04C MED

2,151 TAN 05,671 A02B MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

Indomethacin BP

25 mg

36

Medopharm
INDIA

Diazepam BP

5 mg

36

Medopharm
INDIA

20 mg

36

Medopharm
INDIA

60 mg

60

Medopharm
INDIA

250 mg

36

Medopharm
INDIA

36

Medopharm
INDIA

36

Medopharm
INDIA

Diazepam,Tablet

Omeprazole,Capsules

Phenobarbital,Tablet

Phenobarbital BP

2,153 TAN 06,317 J01A MED

Tetracycline,Capsules

Tetracycline Hydrochloride
BP

2,154 TAN 00,4368 R06A MED

Chlorpheniramine,Tablet

Chlorpheniramine Maleate
BP

2,155 TAN 00,4368 R06A MED

Manufacturer

Indomethacin,Capsules

Omeprazole BP

2,152 TAN 06,080 N03A MED

Shelf life
month

Chlorpheniramine,Tablet

Chlorpheniramine Maleate
BP

Page 337 of 584

Human Medicinal Products


S/No:

Registration Number

2,156 TAN 00,4369 B03A MED

2,157 TAN 00,4369 B03A MED

2,158 TAN 00,4405 P01B MED

2,159 TAN 00,4405 P01B MED

2,160 TAN 00,4419 J03B MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

Folic Acid BP

36

Medopharm
INDIA

Folic Acid BP

36

Medopharm
INDIA

Sulfadoxine USP
Pyrimethamine USP

500 mg
25 mg

36

Medopharm
INDIA

Sulfadoxine USP
Pyrimethamine USP

500 mg
25 mg

36

Medopharm
INDIA

400
80

36

Medopharm
INDIA

400
80

36

Medopharm
INDIA

250

36

Medopharm
INDIA

Folic Acid,Tablet

Pyrimethamine +
Sulfadoxine,Tablet

Pyrimethamine +
Sulfadoxine,Tablet

Co Trimoxazole,Tablet

Co Trimoxazole,Tablet

Sulfamethoxazole BP
Trimethoprim BP

2,162 TAN 00,4566 P01A MED

Manufacturer

Folic Acid,Tablet

Sulfamethoxazole BP
Trimethoprim BP

2,161 TAN 00,4419 J03B MED

Shelf life
month

Metronidazole,Tablet

Metronidazole BP

Page 338 of 584

Human Medicinal Products


S/No:

Registration Number

2,163 TAN 00,4566 P01A MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

250

36

Medopharm
INDIA

250 mg

36

Medopharm
INDIA

Chlorpropamide BP

250 mg

36

Medopharm
INDIA

Albendazole USP

200

36

Medopharm
INDIA

Albendazole USP

200

36

Medopharm
INDIA

36

Medopharm
INDIA

36

Medopharm
INDIA

Chlorpropamide,Tablet

Chlorpropamide BP

2,165 TAN 00,4429 A10B MED

2,166 TAN 00,4425 P02X MED

2,167 TAN 00,4425 P02X MED

2,168 TAN 00,4424 R06A MED

Chlorpropamide,Tablet

Albendazole,Tablet

Albendazole,Tablet

Promethazine,Tablet

Promethazine Hydrochloride 25 mg
BP

2,169 TAN 00,4424 R06A MED

Manufacturer

Metronidazole,Tablet

Metronidazole BP

2,164 TAN 00,4429 A10B MED

Shelf life
month

Promethazine,Tablet

Promethazine Hydrochloride 25 mg
BP

Page 339 of 584

Human Medicinal Products


S/No:

Registration Number

2,170 TAN 00,4431 N04A MED

2,171 TAN 00,4430 N04A MED

2,172 TAN 00,4428 A03B MED

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,173 TAN 10, 036 MEG

Chlorpromazine BP
Chlorpromazine
Hydrochloride BP

26 mg
25 mg

36

Medopharm
INDIA

Haloperidol BP

1.5 mg

36

Medopharm
INDIA

10 mg

36

Medopharm
INDIA

0.25 mcg

24

Mega Lifescience Ltd.


THAILAND

Haloperidol,Tablet

Hyoscine Butylbromide,Tablet

Mega Lifescience Ltd. - THAILAND


Meditrol,Capsules

Calcitriol BP

Registrant
2,174 TAN 05,118 D01B MAC

Mek one genaral traders Ltd - TANZANIA


Fulvin,Tablet

Griseofulvin BP

2,175 TAN 06,184 D01A MAC

500 mg

36

100000 IU/ml

36

Mek one genaral traders


Ltd
TANZANIA

Nystatin,Suspension

Nystatin BP

Registrant

Manufacturer

Chlorpromazine,Tablet

Hyoscine Butylbromide BP

Registrant

Shelf life
month

Memphis Pharma & Chemical Ind. Co. - EGYPT


Page 340 of 584

Mek one genaral traders


Ltd
TANZANIA

Human Medicinal Products


S/No:

Registration Number

2,176 TAN 00,4479 N02B MEM

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,177 TAN 00,4484 J01D MEP

2,178 TAN 00,4485 A02B MEP

2,179 TAN 00,4483 A02B MEP

2,180 TAN 00,4615 A11J MEP

Manufacturer

Tramol,Capsules

Tramadol Hydrochloride IH 50 mg

Registrant

Shelf life
month

36

Memphis Pharma &


Chemical Ind. Co.
EGYPT

Mepha Ltd - SWITZERLAND


Mesporin,Powder for Injection

Ceftriaxone Sodium Ph Eur 250 mg/vial

36

Omeprazole Ph Eur

10 mg

36

Omeprazole Ph Eur

40 mg

36

Labesfal-Laboratorios
Almiro S.A
PORTUGAL

Gasec,Capsules
Sofarimex Industria
Qumica e Farmaceutica,
Lda
PORTUGAL

Gasec,Capsules

Vitiron,Capsules

Page 341 of 584

Sofarimex Industria
Qumica e Farmaceutica,
Lda
PORTUGAL

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

108.9 mg
Ascorbic Acid Ph Eur
10 mg
DL-Methionine Ph Eur
0.575 mg
Folic Acid Ph Eur
1.15 mg
Cyanocobalamine Ph Eur
15 mg
Inositol IH
4.5 mg
Potassium Sulphate IH
0.282 mg
Sodium Molybdate IH
1.26 mg
Copper Sulphate IH
Choline Hydrogentartrate
31.4 mg
IH
Manganese Sulphate USP 1.55 mg
Ferrous Sulphate
99 mg
BP/Ph.Eur
Thiamine Nitrate BP/Ph.Eur 7.5 mg
0.625 mg
Zinc Oxide BP/Ph.Eur
Calcium Pantothenate
5.2 mg
BP/Ph.Eur
Alpha Tocopheryl Acetate
2.1 mg
BP/Ph.Eur
Potasium Iodide BP/Ph.Eur 98 mg
Retinol Palmitate
3666 IU
BP/Ph.Eur
Cholecalciferol BP/Ph.Eur 1100 IU
Calcium Hydrogen
255 mg
phosphate BP/Ph.Eur
2.75 mg
Riboflavin BP/Ph.Eur
42 mg
Nicotinamide BP/Ph.Eur
Pyridoxine Hydrochloride
0.525 mg
Ascorbic Acid BP/Ph.Eur

2,181 TAN 05,076 P01B MEP

Shelf life
month
48

Manufacturer
R.P Scherer GmBH and
Company Kg
GERMANY

Plasmotrim,Capsules

Artesunate Ph Eur

Page 342 of 584

50 mg

36

Mepha Ltd
SWITZERLAND

Human Medicinal Products


S/No:

Registration Number

2,182 TAN 05,786 A16A MEP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Neurorubine,Injectable
Solution

2,184 TAN 05,788 D04A MEP

2,185 TAN 05,787 N06A MEP

2,186 TAN 00,1452 N02B MES

2,187 TAN 00,1450 B03A MES

Manufacturer

36

Merckle GmbH
GERMANY

Thiamine Hydrochloride Ph 100 mg


Eur
1 mg
Cyanocobalamin Ph Eur
Pyridoxine Hydrochloride
100 mg
Ascorbic Acid Ph Eur

24

Merckle GmbH
GERMANY

Loratadine Ph Eur

10 mg

24

Fluoxetine Hydrochloride
Ph Eur

20 mg

36

Mepha Ltd
SWITZERLAND

Tramadol Hydrochloride Ph 50 mg
Eur

60

Mepha Ltd
SWITZERLAND

36

Mepha Ltd
SWITZERLAND

Thiamine Hydrochloride Ph 100 mg


Eur
1 mg
Cyanocobalamine Ph Eur
Pyridoxine Hydrochloride
100 mg
Ascorbic Acid Ph Eur

2,183 TAN 05,786 A16A MEP

Shelf life
month

Neurorubine,Injection

Loraxine-10,Tablet
Sofarimex Industria
Qumica e Farmaceutica,
Lda
PORTUGAL

Salipax,Tablet

Trabilin,Capsules

Aktiferrin F Suscaps,Capsules

Dried Ferrous Sulphate BP


Folic Acid Ph Eur
DL-Serine IH

Page 343 of 584

105.06 mg
0.5 mg
129 mg

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

2,188 TAN 06,420 R06A MEP

Zetry-Mepha,Tablet

2,189 TAN 07,343 C04A MEP

2,190 TAN 08,152 M01A MEP

2,191 TAN 09,029 J01C MEP

Ingredient(s) and Strength

Sofarimex Industria
Qumica e Farmaceutica,
Lda
PORTUGAL

10 mg

24

Sildenafil Citrate Ph Eur

50 mg

36

NPI
Oman

Diclofenac Sodium Ph Eur

1 %w/w

36

Merckle GmbH
GERMANY

24

Lek Pharmaceuticals
SLOVENIA

24

Lek Pharmaceuticals
SLOVENIA

24

Lek Pharmaceuticals
SLOVENIA

Erasmo,Tablet

Olfen,Gel

Co Amox-Mepha,Suspension

Co Amox-Mepha,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin Ph
Eur
Potassium Clavunate
31.25 mg/5ml
Equivalent to Clavulanic
Acid Ph Eur
2,193 TAN 09,028 J01C MEP

Manufacturer

Cetrizine Hydrochloride Ph
Eur

Potassium Clavulanate eq to 31.25 mg/5ml


Clavulanic Acid Ph Eur
Amoxicillin Trihydrate eq to 125 mg/5ml
Amoxicillin Ph Eur
2,192 TAN 09,029 J01C MEP

Shelf life
month

CO AMOX-MEPHA
457/5ML,Suspension

Amoxicillin Trihydrate eq to 14.256mg mg/5ml


Amoxicillin Ph Eur
Potassium Clavulanate eq to 91.84mg mg/5.4g
Clavulanic Acid Ph Eur

Page 344 of 584

Human Medicinal Products


S/No:

Registration Number

2,194 TAN 05,076 P01B MEP

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,196 TAN 05,672 P01B MEP

2,197 TAN 05,672 P01B MEP

Registrant
2,198 TAN 09,177 S01D E

50 mg

36

Mepha Ltd
SWITZERLAND

Artesunate Ph Eur

50 mg

36

Mepha Ltd
SWITZERLAND

Artesunate IH
Mefloquine Hydrochloride
IH

100 mg
125 mg

36

Mepha Ltd
SWITZERLAND

Artesunate IH
Mefloquine Hydrochloride
IH

100 mg
125 mg

36

Mepha Ltd
SWITZERLAND

0.275 mg/ml

36

E. Merck (India) Limited


INDIA

10 mg
3 mg

18

Mansoor Daya Chemicals


TANZANIA

Plasmotrim,Capsules

Artequin,Tablet

Artequin,Tablet

Merck (India) Ltd. - INDIA


Nasivion,Drops

Oxymetazoline
Hydrochloride USP

2,199 TAN 00,2321 A11E E.

Manufacturer

Plasmotrim,Capsules

Artesunate Ph Eur

2,195 TAN 05,076 P01B MEP

Shelf life
month

Neurobion Forte,Tablet

Thiamine Nitrate BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Cyanocobalamin BP
Nicotinamide BP
Calcium Pantothenate BP

Page 345 of 584

1.5 mg
100 mg
50 mg

Human Medicinal Products


S/No:

Registration Number

2,200 TAN 00,1970 A11B EME

Product Name
Pack and Pack size

Ingredient(s) and Strength

Neurobion Forte,Injectable
Solution

Dexapanthenol BP
Thiamine BP
Cyanocobalamin BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Potasium Cyanide BP

2,201 TAN 00,2321 A11E E.

Neurobion Forte,Injectable
Solution

Dexapanthenol BP
Thiamine BP
Cyanocobalamin BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Potasium Cyanide BP

2,203 TAN 00,1970 A11B EME

Neurobion Forte,Injectable
Solution

Dexapanthenol BP
Thiamine BP
Cyanocobalamin BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Potasium Cyanide BP

Registrant

Manufacturer

18

Merck (India) Ltd.


INDIA

18

Mansoor Daya Chemicals


TANZANIA

18

Merck (India) Ltd.


INDIA

18

Merck (India) Ltd.


INDIA

250 mg

Neurobion Forte,Tablet

Thiamine Nitrate BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Cyanocobalamin BP
Nicotinamide BP
Calcium Pantothenate BP
2,202 TAN 00,1970 A11B EME

50 mg
100 mg
1000 mcg
100 mg
100 mg

Shelf life
month

Merck Limited - INDIA

Page 346 of 584

10 mg
3 mg
1.5 mg
100 mg
50 mg

50 mg
100 mg
1000 mcg
100 mg
100 mg
250 mg

50 mg
100 mg
1000 mcg
100 mg
100 mg
250 mg

Human Medicinal Products


S/No:

Registration Number

2,204 TAN 00,4486 A11H MER

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,205 F143 A1

2,206 TAN 09,051 J05A MSD

Registrant
2,207 TAN 06,083 J05A MER

2,208 TAN 06,082 J05A MER

2,209 TAN 06,187 J05A MER

Registrant

Manufacturer

Evion,Capsules

Tocopheryl Acetate
Nicotinamide
Dexapanthenol USP

Registrant

Shelf life
month

400 mg

24

Merck (India) Ltd.


INDIA

24

Patheon Inc
CANADA

Merck Sharp & Dohme (Pty) Ltd. - SOUTH AFRICA


Atripla,Tablet

Efavirenz IH
Tenofovir Disoproxil
Fumarate IH
Emtricitabine IH

600 mg
300 mg

Raltegravir IH

400 mg

200 mg

Isentress,Tablet
30

Merck Shap and Dohme


B.V
USA

Merck Sharp & Dohme Ltd. - UNITED KINGDOM


Stocrin,Capsules

Efavirenz IH

50 mg

36

Merck Sharp & Dohme


NETHERLANDS

Efavirenz Ph Eur

200 mg

36

Merck Sharp & Dohme


NETHERLANDS

Efavirenz IH

600 mg

24

Stocrin,Capsules

Stocrin,Tablet

Micro Healthcare (Pty) Ltd. - SOUTH AFRICA


Page 347 of 584

Merck Sharp & Dohme


Australia Pty
AUSTRALIA

Human Medicinal Products


S/No:

Registration Number

2,210 TAN 06,086 J01K MIC

Product Name
Pack and Pack size

Ingredient(s) and Strength

24

Micro Healthcare (Pty) Ltd.


SOUTH AFRICA

24

Micro Healthcare (Pty) Ltd.


SOUTH AFRICA

24

Micro Healthcare (Pty) Ltd.


SOUTH AFRICA

10 mg/ml

36

Micro Healthcare (Pty) Ltd.


SOUTH AFRICA

1 mg/ml

24

Micro Healthcare (Pty) Ltd.


SOUTH AFRICA

50 mg

36

Micro Labs Ltd.


INDIA

20 mg/2ml

Micro Pethidine,Injection

Pethidine Hydrochloride BP 50 mg/ml

2,212 TAN 06,088 N02A MIC

Micro Pethidine,Injection

Pethidine Hydrochloride BP 100 mg/2ml

2,213 TAN 06,087 V03A MIC

Micro Morphine,Injection

Morphine Sulphate BP

2,214 TAN 06,318 A03B MIC

Micro Atropine,Injection

Atropine Sulphate BP

Registrant
2,215 TAN 09,178 C06A MIC

Manufacturer

Micro Gentamicin,Injection

Gentamycin Sulphate BP

2,211 TAN 06,085 N02A MIC

Shelf life
month

Micro Labs Ltd - INDIA


Betadure 50,Tablet

Atenolol BP

Page 348 of 584

Human Medicinal Products


S/No:

Registration Number

2,216 TAN 00,4371 J04A MIC

Product Name
Pack and Pack size

Ingredient(s) and Strength

400 mg

36

Micro Labs Ltd.


INDIA

100 mg
150 mg

24

Micro Labs Ltd.


INDIA

500 mg

36

Micro Labs Ltd.


INDIA

Isoniazid USP
Pyrazinamide USP
Rifampicin USP

50 mg
300 mg
120 mg

60

Micro Labs Ltd.


INDIA

Clarithromycin USP

500 mg

36

Micro Labs Ltd.


INDIA

Metformin Hydrochloride BP 500 mg

36

Micro Labs Ltd.


INDIA

Ibuprofen BP

36

Micro Labs Ltd.


INDIA

Rifampicin + Isoniazid,Tablet

Isoniazid BP
Rifampicin BP

2,218 TAN 00,4488 J04A MIC

Pyrazinamide,Tablet

Pyrazinamide BP

2,219 TAN 05,513 J04A MIC

2,220 TAN 05,674 J01F MIC

2,221 TAN 05,790 A10B MIC

2,222 TAN 05,791 M01A MIC

Manufacturer

Ethambutol,Tablet

Ethambutol Hydrochloride
BP

2,217 TAN 00,4370 J04A MIC

Shelf life
month

Isoniazid + Pyrazinamide +
Rifampin,Tablet

Clarisol,Tablet

Metformin,Tablet

Ibuprofen,Tablet

Page 349 of 584

200 mg

Human Medicinal Products


S/No:

Registration Number

2,223 TAN 05,792 J01K MIC

2,224 TAN 09,031 A10B MIC

2,225 TAN 05,673 J01F MIC

2,226 TAN 06,091 N02B MIC

2,227 TAN 06,089 B04A MIC

2,228 TAN 06,090 B04A MIC

2,229 TAN 06,089 B04A MIC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Levobact-500,Tablet

Levofloxacin Hemihydrate
IH

500 mg

36

Micro Labs Ltd.


INDIA

Pioglitazone Hydrocloride
equivalent Pioglitazone IH

30 mg

24

Micro Labs Ltd.


INDIA

Clarithromycin USP

250 mg

36

Micro Labs Ltd.


INDIA

Paracetamol BP

500 mg

48

Micro Labs Ltd.


INDIA

Atorvastatin IH

20 mg

24

Micro Labs Ltd.


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

10 mg

22

Micro Labs Ltd.


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

10 mg

22

Micro Labs Ltd.


INDIA

Pionorm,Tablet

Clarisol,Tablet

Paracetamol,Tablet

Avas-20,Tablet

Avas-10,Tablet

Avas - 20,Tablet

Page 350 of 584

Human Medicinal Products


S/No:

Registration Number

2,230 TAN 06,189 A10B MIC

2,231 TAN 06,190 A10B MIC

2,232 TAN 06,191 R06A MIC

2,233 TAN 06,192 C01E MIC

2,234 TAN 06,194 C01E MIC

2,235 TAN 06,195 A02B MIC

2,236 TAN 06,193 A02B MIC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Diapride,Tablet

Glimepiride IH

1 mg

36

Micro Labs Ltd.


INDIA

Glimepiride IH

2 mg

36

Micro Labs Ltd.


INDIA

Ebastine BP

10 mg

24

Micro Labs Ltd.


INDIA

Losartan Potassium IH

50 mg

24

Micro Labs Ltd.


INDIA

Losartan Potassium IH

25 mg

24

Micro Labs Ltd.


INDIA

Cimetidine USP

200 mg

36

Micro Labs Ltd.


INDIA

24

Micro Labs Ltd.


INDIA

Diapride,Tablet

Ebast,Tablet

Angizaar-50,Tablet

Angizaar-25,Tablet

Cimetidine,Tablet

Pantocar-40,Tablet

Pantoprazole Sodium
40 mg
Sesquihydrate equivalent to
Pantoprazole IH

Page 351 of 584

Human Medicinal Products


S/No:

Registration Number

2,237 TAN 06,320 C06A MIC

2,238 TAN 06,319 A02B MIC

2,239 TAN 06,257 J01C BRO

2,240 TAN 06,422 B01A MIC

2,241 TAN 06,423 C01E MIC

2,242 TAN 07,082 A10B MIC

2,243 TAN 07,081 P02A MIC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Carvipress-6.25,Tablet

Carvedilol BP

6.25 mg

24

Micro Labs Ltd.


INDIA

Cimetidine USP

400 mg

36

Micro Labs Ltd.


INDIA

Clavulanic Acid IH
Amoxycillin USP

125 mg
500 mg

18

Clopidogrel Bisulfate IH

75 mg

24

Micro Labs Ltd.


INDIA

Losartan Potassium IH
Hydrochlorthiazide USP

50 mg
12.5 mg

24

Micro Labs Ltd.


INDIA

Gliclazide BP

80 mg

48

Micro Labs Ltd.


INDIA

Praziquantel USP

600 mg

36

Micro Labs Ltd.


INDIA

Cimetidine,Tablet

Bactoclav-625,Tablet
Brown & Bulk
Pharmaceutical Ltd
INDIA

Plagerine,Tablet

Angizaar-H,Tablet

Dianorm,Tablet

Praziquantel,Tablet

Page 352 of 584

Human Medicinal Products


S/No:

Registration Number

2,244 TAN 07,083 A07D MIC

Product Name
Pack and Pack size

Ingredient(s) and Strength

2 mg

42

Micro Labs Ltd.


INDIA

12.5 mg

24

Micro Labs Ltd.


INDIA

Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin BP

36

Micro Labs Ltd


INDIA

Cefalexin BP

500 mg

36

Micro Labs Ltd


INDIA

5 mg

36

Micro Labs Ltd.


INDIA

Cetrizine Hydrochloride BP 10 mg

36

Micro Labs Ltd.


INDIA

Amlodipine Besylate BP

30

Micro Labs Ltd.


INDIA

Carvipress-12.5,Tablet

Carvedilol BP

2,246 TAN 07,345 J01H MIC

2,247 TAN 07,344 J01D MIC

2,248 TAN 07,509 A10B MIC

Pulmoxyl,Capsules

Cefex-500,Capsules

Glibenclamide,Tablet

Glibenclamide BP

2,249 TAN 07,510 R06A MIC

2,250 TAN 07,511 C01K MIC

Manufacturer

Eldoper,Capsules

Loperamide Hydrochloride
USP

2,245 TAN 07,201 C06A MIC

Shelf life
month

Allercet,Tablet

Amlong,Tablet

Page 353 of 584

5 mg

Human Medicinal Products


S/No:

Registration Number

2,251 TAN 07,512 J01E MIC

2,252 TAN 07,513 J01F MIC

2,253 TAN 07,514 P02X MIC

2,254 TAN 07,515 A03B MIC

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,256 TAN 08,018 A10B MIC

2,257 TAN 08,078 J01F MIC

Manufacturer

Mortin,Tablet

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

48

Micro Labs Ltd.


INDIA

Azithromycin Dihydrate
equivalent to Azithromycin
USP

500 mg

24

Micro Labs Ltd.


INDIA

Albendazole USP

400 mg

48

Micro Labs Ltd.


INDIA

10 mg

24

Micro Labs Ltd.


INDIA

Ciprofloxacin Hydrochloride 500 mg


USP

36

Micro Labs Ltd.


INDIA

80 mg
Gliclazide BP
Metformin Hydrochloride BP 500 mg

24

Micro Labs Ltd.


INDIA

Azithromycin USP

24

Micro Labs Ltd.


INDIA

Azilide,Tablet

Albendol,Tablet

Hyoscine Butylbromide,Tablet

Hyoscine Butylbromide BP

2,255 TAN 07,508 J01K MIC

Shelf life
month

Cenox,Tablet

Dianorm-M,Tablet

Azilide,Tablet

Page 354 of 584

250 mg

Human Medicinal Products


S/No:

Registration Number

2,258 TAN 00,4311 A02B MIC

2,259 TAN 00,4312 J01A MIC

2,260 TAN 09,030 A10B MIC

2,261 TAN 09,031 A10B MIC

2,262 TAN 10,037 J02A MIC

2,263 TAN 10, 068,C01K

2,264 TAN 10, 069 C01K

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Omicap,Capsules

Omeprazole IH

20 mg

24

Micro Labs Ltd.


INDIA

Doxycycline Hyclate BP

100 mg

24

Micro Labs Ltd.


INDIA

Pioglitazone Hydrocloride
equivalent Pioglitazone IH

30 mg

30

Micro Labs Ltd.


INDIA

Pioglitazone Hydrocloride
equivalent Pioglitazone IH

30 mg

24

Micro Labs Ltd.


INDIA

Ketoconazole USP

2 %w/w

24

Micro Labs Ltd.


INDIA

Ramipril BP

2.5 mg

18

Micro Labs Ltd.


INDIA

Ramipril USP

5 mg

18

Micro Labs Ltd.


INDIA

Microdox,Capsules

Pionorm,Tablet

Pionorm,Tablet

Phytoral,Ointment

Ramiril,Capsules

Ramiril,Capsules

Page 355 of 584

Human Medicinal Products


S/No:

Registration Number

2,265 TAN 00,4312 J01A MIC

2,266 TAN 00,4312 J01A MIC

Registrant
2,267 TAN 07,202 J01H MIL

2,268 TAN 07,348 J01H MIL

2,269 TAN 07,346 J01H MIL

2,270 TAN 07,347 J01H MIL

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Microdox,Capsules

Doxycycline BP
Doxycycline Hyclate BP

100 mg
100 mg

24

Micro Labs Ltd.


INDIA

Doxycycline BP
Doxycycline Hyclate BP

100 mg
100 mg

24

Micro Labs Ltd.


INDIA

Microdox,Capsules

Milan Laboratories (India) Pvt Ltd. - INDIA


Milcillin-S,Suspension

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg/5ml

24

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

24

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin BP

24

Milan Laboratories (India)


Pvt Ltd.
INDIA

Milcillin,Capsules
Milan Laboratories (India)
Pvt Ltd.
INDIA

Miloxy,Capsules
Milan Laboratories (India)
Pvt Ltd.
INDIA

Miloxy,Capsules

Page 356 of 584

Milan Laboratories (India)


Pvt Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

2,271 TAN 07,349 J01H MIL

2,272 TAN 07,350 J01H MIL

2,273 TAN 07,351 J01H MIL

2,274 TAN 07,352 J01C MIL

2,275 TAN 07,203 J01H MIL

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,276 TAN 00,4407 A06A MIR

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

24

Amoxicillin Trihydrate
250 mg/5ml
equivalent to Amoxicillin BP

24

Ampicillin Sodium
equivalent to Ampicillin BP

500 mg

24

Ampicillin Sodium
250 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

24

Milan Laboratories (India)


Pvt Ltd.
INDIA

Miloxy,Suspension
Milan Laboratories (India)
Pvt Ltd.
INDIA

Milcillin,Capsules
Milan Laboratories (India)
Pvt Ltd.
INDIA

Miclox,Capsules
Milan Laboratories (India)
Pvt Ltd.
INDIA

Milcillin,Suspension
125 mg/5ml

24

Milan Laboratories (India)


Pvt Ltd.
INDIA

Misr Company for Pharmaceutical Industries - EGYPT


Phosphate Enema,Solution

Sodium Acid Phosphate BP 16 g/100ml


6 g/100ml
Sodium Phosphate BP

Registrant

Manufacturer

Miloxy,Suspension

Ampicillin Trihydrate
equivalent to Ampicillin BP

Registrant

Shelf life
month

Missionpharma A/S. - DENMARK

Page 357 of 584

36

Misr Company for


Pharmaceutical Industries
EGYPT

Human Medicinal Products


S/No:

Registration Number

2,277 TAN 09,179 A03B MIS

Product Name
Pack and Pack size

Ingredient(s) and Strength

10 mg

36

Cipla Ltd.
INDIA

Lidocaine
Hydrochloride,Injectable
Lidocaine Hydrochloride
Solution

10 mg

36

Strides Arcolab Ltd


INDIA

Chloramphenicol Sodium
Succinate,Powder for
Chloramphenicol Sodium
Injection

1g

36

Strides Arcolab Ltd


INDIA

36

Strides Arcolab Ltd


INDIA

36

Modern Pharma Industries


REP. OF YEMEN

36

Modern Pharma Industries


REP. OF YEMEN

USP

2,279 TAN 05,190 J01B MIS

Succinate eq. to
Chloramphenicol BP

2,280 TAN 05,188 V03A MIS

Adrenaline,Injectable Solution

Adrenaline acid tartrate


1 mg/ml
equivalent to adrenaline BP

Registrant
2,281 TAN 05,077 J01D MOD

Modern Pharma Industries - REP. OF YEMEN


Cephalexin,Capsules

Cephalexin Monohydrate
equivalent to Cephalexin
Anhydrous USP
2,282 TAN 05,515 J01C MOD

Manufacturer

Hyoscine,Tablet

Hyoscine Butylbromide BP

2,278 TAN 05,189 N01B MIS

Shelf life
month

500 mg

Cloxamin,Syrup

Cloxacillin Sodium
125 mg/5ml
Monohydrate USP
Ampicillin Trihydrate
125 mg/5ml
equivalent to Ampicillin USP

Page 358 of 584

Human Medicinal Products


S/No:

Registration Number

2,283 TAN 05,516 J01D MOD

2,284 TAN 05,514 J01D MOD

2,285 TAN 05,517 J01D MOD

Registrant
2,286 TAN 07,323 J01D IND

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,287 TAN 06,282 J05A F.H

Cefadroxil Monohydrate
equivalent to Cefadroxil
Anhydrous USP

500 mg

36

Modern Pharma Industries


REP. OF YEMEN

Cefadroxil Monohydrate
USP

250 mg/5ml

36

Modern Pharma Industries


REP. OF YEMEN

Cephradine Monohydrate
equivalent to Cephradine
Anhydrous USP

500 mg

36

Modern Pharma Industries


REP. OF YEMEN

1g

24

Indus Pharma (Pvt) Ltd.


PAKISTAN

Cefacure,Syrup

Modecef,Capsules

Moonas Pharmacy - TANZANIA


Maxef,Injection

Mova Pharmaceutical Corporation - PUERTO RICO


Viracept,Powder

Nelfinavir Mesylate IH

Registrant
2,288 TAN 09,288 J07A MSD

Manufacturer

Cefacure,Capsules

Ceftriaxone Sodium eq to
Ceftriaxone USP

Registrant

Shelf life
month

50 mg/g

36

Mova Pharmaceutical
Corporation
PUERTO RICO

MSD Interpharma - FRANCE


Gardasil,Vaccine
36

Page 359 of 584

Merck Sharp & Dohme


NETHERLANDS

Human Medicinal Products


S/No:

Registration Number

Registrant
2,289 TAN 00,4513 J05A MER

2,290 TAN 00,4513 J05A MER

2,291 TZ10H102

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,292 TAN 00,140 G03A ORG

2,293 TAN 00,793 G03A ORG

2,294 TAN 00,138 D07A ORG

Manufacturer

MURZAH OIL MILLS (T) LTD - TANZANIA


Stocrin,Solution

Efavirenz IH

30 mg/ml

24

Merck Sharp & Dohme


NETHERLANDS

Efavirenz IH

30 mg/ml

24

Merck Sharp & Dohme


NETHERLANDS

0.5 %w/v

24

MURZAH OIL MILLS (T) LTD


TANZANIA

Lynestrenol Ph Eur

0.5 mg

60

N.V Organon
NETHERLANDS

Etonogestrel IH

68 mg

36

N.V Organon
NETHERLANDS

Desogestrel Ph Eur
Ethinylestradiol Ph Eur

0.15 mg
0.03 mg

36

N.V Organon
NETHERLANDS

Stocrin,Solution

Occumol
0.5%w/v,Ophthalmic Solution

Timolol Maleate BP

Registrant

Shelf life
month

N.V Organon - NETHERLANDS


Exluton,Tablet

Implanon,Implant

Marvelon,Tablet

Page 360 of 584

Human Medicinal Products


S/No:

Registration Number

2,295 TAN 00,138 D07A ORG

Product Name
Pack and Pack size

Ingredient(s) and Strength

0.15 mg
0.03 mg

36

N.V Organon
NETHERLANDS

150 mg

36

N.V Organon
NETHERLANDS

Medroxyprogesterone
Acetate IH

150 mg

36

N.V Organon
NETHERLANDS

Lynestrenol Ph Eur

0.5

60

N.V Organon
NETHERLANDS

Methylprednisolone IH

0.1 %w/w

36

Schering SpA
ITALY

Methylprednisolone IH

0.1 %w/w

36

Schering SpA
ITALY

Megestron,Injectable Solution

Medroxyprogesterone
Acetate IH

2,297 TAN 00,141 G03E ORG

2,298 TAN 00,140 G03A ORG

Registrant
2,299 TAN 05,794 D07A N.V

2,300 TAN 05,793 D07A N.V

Manufacturer

Marvelon,Tablet

Desogestrel Ph Eur
Ethinylestradiol Ph Eur

2,296 TAN 00,141 G03E ORG

Shelf life
month

Megestron,Injectable Solution

Exluton,Tablet

N.V Schering A.G - BELGIUM


Advantan,Ointment

Advantan,Cream

Page 361 of 584

Human Medicinal Products


S/No:

Registration Number

2,301 TAN 00,569 D07X SCH

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,303 TAN 06,197 G03A N.V

2,304 TAN 07,085 V07A N.V

N.V Schering S.A


GERMANY

1 g/100g

469 mg

36

Schering AG
GERMANY

Levonorgestrel IH

0.03 gm

60

Schering AG
GERMANY

0.623 mg/ml

36

N.V Schering S.A


GERMANY

0.623 g/ml

36

N.V Schering S.A


GERMANY

5 mg
1.3 mg
1 mg

60

N.V Schering S.A


GERMANY

0.1 %w/w

36

Schering SpA
ITALY

Microlut,Tablet

Ultravist,Injectable Solution

Ultravist,Injectable Solution

Scheriproct,Suppositories

Clemizole Undecylate IH
Predinisolone Caproate IH
Cinchocaine Hydrochloride
Ph Eur
2,307 TAN 05,794 D07A N.V

60

Gadopentetic acid IH

Iopromide IH

2,306 TAN 00,112 D07X SCH

0.1 g/100g

Magnevist,Injectable Solution

Iopromide IH

2,305 TAN 07,084 V07A N.V

Manufacturer

Travocort,Cream

Diflucortolone Valerate Ph
Eur
Isoconazole Nitrate Ph Eur
2,302 TAN 06,196 V07A N.V

Shelf life
month

Advantan,Ointment

Methylprednisolone IH

Page 362 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

2,308 TAN 05,794 D07A N.V

Advantan,Ointment

2,309 TAN 05,793 D07A N.V

2,310 TAN 05,793 D07A N.V

Registrant
2,311 TAN 05,192 J01B NAB

Ingredient(s) and Strength

0.1 %w/w

36

Schering SpA
ITALY

Methylprednisolone IH

0.1 %w/w

36

Schering SpA
ITALY

Methylprednisolone IH

0.1 %w/w

36

Schering SpA
ITALY

Advantan,Cream

Advantan,Cream

Nabiqasim Industries (PVT) Ltd - PAKISTAN


Comycetin,Ophthalmic
Solution

200 mg

Gentabact,Ophthalmic
Solution

Gentamicin Sulphate
3 mg/ml
equivalent to Gentamicin BP

2,313 TAN 05,191 J01B NAB

Manufacturer

Methylprednisolone IH

Chloramphenicol BP

2,312 TAN 05,193 J01K NAB

Shelf life
month

36

36

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Comycetin,Solution

Chloramphenicol BP

Page 363 of 584

50 mg/10ml

36

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Human Medicinal Products


S/No:

Registration Number

2,314 TAN 07,520 G02C NAB

2,315 TAN 07,518 P01A NAB

2,316 TAN 07,516 D01A NAB

2,317 TAN 07,517 P02X NAB

2,318 TAN 07,519 C01K NAB

2,319 TAN 07,521 J02A NAB

2,320 TAN 07,522 H02A NAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Clomitab,Tablet

Clomifene Citrate BP

50 mg

24

Secnidazole
Secnidazole BP

1000 mg

24

Clotrimazole USP

1%

24

Mebendazole BP

135 mg

24

Atenolol BP

50 mg

24

Fluconazole IH

150 mg

24

Neomycin Sulphate BP
Dexamethasone Sodium
Phosphate BP

5.5 mg/ml
1 mg/ml

24

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Dysen Forte,Tablet
Nabiqasim Industries (Pvt)
Ltd.
PAKISTAN

Dermosporin,Cream
Nabiqasim Industries (Pvt)
Ltd.
PAKISTAN

Colospas,Tablet
Nabiqasim Industries (Pvt)
Ltd.
PAKISTAN

Normitab,Tablet
Nabiqasim Industries (Pvt)
Ltd.
PAKISTAN

Fluderm,Capsules
Nabiqasim Industries (Pvt)
Ltd.
PAKISTAN

Dexwin,Solution

Page 364 of 584

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Human Medicinal Products


S/No:

Registration Number

2,321 TAN 08,105 V07A NAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,323 TAN 05,193 J01K NAB

0.3 mg
3.35 mg
0.55 mg

24

Gentamicin Sulphate
3 mg/ml
equivalent to Gentamicin BP

36

Gentabact,Ophthalmic
Solution

Gentabact,Ophthalmic
Solution

Gentamicin Sulphate
3 mg/ml
equivalent to Gentamicin BP

2,324 TAN 05,192 J01B NAB

Comycetin,Ophthalmic
Solution

Chloramphenicol BP
Lignocaine BP

2,325 TAN 05,191 J01B NAB

2,326 TAN 09,052 P01A NAN

21 mg
10 mg

36

5.50 mg/10ml

36

250 mg

36

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Nanjing Baijingyy - CHINA


Flazol,Tablet

Metronidazole BP

Registrant

36

Nabiqasim Industries (Pvt)


Ltd.
PAKISTAN

Comycetin,Solution

Chloramphenicol BP

Registrant

Manufacturer

Detoxicol,Syrup

Lactose USP
Lactulose USP
Galactose USP
2,322 TAN 05,193 J01K NAB

Shelf life
month

Naprod Life Sciences Pvt Ltd. - INDIA

Page 365 of 584

Nanjing Baijingyy
CHINA

Human Medicinal Products


S/No:

Registration Number

2,327 TZ11H171

Product Name
Pack and Pack size

Ingredient(s) and Strength

100 mg

ABINGEM-1gm,Lyophilized
Injection

Gemcitabine Hydrochloride 1 mg
USP

Registrant
2,329 TAN 05,177 A02B FOU

2,331 TAN 06,285 A10B FOU

24

24

Naprod Life Sciences Pvt


Ltd.
INDIA

Naprod Life Sciences Pvt


Ltd.
INDIA

Natures Grace medicine SDN BHD - MALAYSIA


Sucrafil,Suspension

Sucralfate USP

2,330 TAN 10, 061 J01D

Manufacturer

Cancyt 100ml,Injection

Cytarabine BP

2,328 TZ11H172

Shelf life
month

1g

36

Natures Grace medicine


SDN BHD
MALAYSIA

Redin np,Liquid
50 mg/5ml
Calcium Lactate BP
0.5 mg/5ml
Folic Acid BP
25 mcg/5ml
Copper Sulphate BP
35 mg/5ml
Zinc Sulphate BP
2.5 mcg/5ml
Vitamin B12 BP
100 mg/5ml
Protein Hydrolysate IH
Ferric Ammonium Citrate IH 75 mg/5ml
Selenium (as sodium
25 mg/5ml
selenite) IH

24

Metformin Hydrochloride BP 500 mg

36

Natures Grace medicine


SDN BHD
MALAYSIA

Metfil,Tablet

Page 366 of 584

Natures Grace medicine


SDN BHD
MALAYSIA

Human Medicinal Products


S/No:

Registration Number

2,332 TAN 07,037 D01A FOU

2,333 TAN 00,4346 M01A FOU

2,334 TAN 00,4338 R03A FOU

Product Name
Pack and Pack size

Ingredient(s) and Strength

Clotrimazole USP

1 Capsule %w/w

36

Ibuprofen BP

200 mg

36

Natures Grace medicine


SDN BHD
MALAYSIA

Ibufil,Tablet
Natures Grace medicine
SDN BHD
MALAYSIA

Salfil,Tablet
36

Natures Grace medicine


SDN BHD
MALAYSIA

Redin Plus,Capsules

Folic Acid BP
Histidine Hydrochloride
Monohydrate BP
Iron IH
Selenium IH
Choline Bitartarate USP
Lysine hydrochloride USP
Zinc (As Zinc Sulphate) USP
2,336 TAN 10, 061 J01D

Manufacturer

Fungifen,Cream

Salbutamol Sulphate
4 mg
equivalent to Salbutamol BP

2,335 TAN 09,017 V03A FOU

Shelf life
month

7.5 mg
4.4 mg

24

Natures Grace medicine


SDN BHD
MALAYSIA

100 mg
0.11 mg
52 mg
26 mg
30 mg

Redin np,Liquid
50 mg/5ml
Calcium Lactate BP
0.5 mg/5ml
Folic Acid BP
25 mcg/5ml
Copper Sulphate BP
35 mg/5ml
Zinc Sulphate BP
2.5 mcg/5ml
Vitamin B12 BP
100 mg/5ml
Protein Hydrolysate IH
Ferric Ammonium Citrate IH 75 mg/5ml
Selenium (as sodium
25 mg/5ml
selenite) IH

Page 367 of 584

24

Natures Grace medicine


SDN BHD
MALAYSIA

Human Medicinal Products


S/No:

Registration Number

2,337 TAN 10, 060 V03A

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,338 TAN 00,1121 C01K KOP

2,339 TAN 05,194 G04B THE

2,340 TAN 05,196 J01H NOR

Natures Grace medicine


SDN BHD
MALAYSIA

50 mg
280 mg
50 mcg
25 mg
30 mg

5 mg

24

Kopran Ltd.
INDIA

NILE PERCH FISHERIES LIMITED - TANZANIA


Urosolvine,Effeverscent
Granules

0.128 mg
0.128 mg
0.3 mg

36

NILE PERCH FISHERIES


LIMITED
TANZANIA

North China Pharmaceutical Group Corporation - CHINA


Benzyl Penicillin,Powder for
Injection

Benzyl penicillin Sodium BP 5 MU

2,341 TAN 05,195 J01H NOR

24

Klodip,Tablet

Atropine Sulphate BP
Piperazine Hydrate BP
Colchicine BP

Registrant

5 mg
4 mg

Newton Pharma. - INDIA


Amlodipine Besylate IH

Registrant

Manufacturer

Redin Plus,Capsules

Folic Acid BP
Histidine Hydrochloride
Monohydrate BP
Choline Bitartarate IH
Ferrous Glycine Sulphate IH
Selenium (as sodium
selenite) IH
Lysine hydrochloride USP
Zinc Sulfate Monohydrate
USP

Registrant

Shelf life
month

Procaine penicillin
Fortified,Powder for Injection

3 MU
Procaine Penicillin BP
Benzyl penicillin Sodium BP 1 MU

Page 368 of 584

36

24

North China
Pharmaceutical Group
Corporation
CHINA

North China
Pharmaceutical Group
Corporation
CHINA

Human Medicinal Products


S/No:

Registration Number

2,342 TAN 07,525 P01B NOR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Quinine
Dihydrochloride,Injectable
Quinine Dihydrochloride
Solution

Shelf life
month

600 mg/2ml

36

250 mg

36

2.4 MU

36

250 mg

36

400 mg
80 mg

36

Ampicillin Trihydrate
equivalent to Ampicillin Ph
Eur

250 mg

36

Paracetamol Ph Eur

500 mg

48

BP

2,343 TAN 07,526 J01H NOR

Benzathine Penicillin,Powder
for Injection

Benzathine Penicillin Ph
Eur

2,345 TAN 07,528 J01A NOR

2,348 TAN 10, 086 N02B NOR

North China
Pharmaceutical Fomulation
Co. Ltd.
CHINA

North China
Pharmaceutical
CHINA

Co-trimoxazole,Tablet

Sulfamethoxazole Ph Eur
Trimethoprim Ph Eur

2,347 TAN 07,529 J01H NOR

North China
Pharmaceutical Fomulation
Co. Ltd.
CHINA

Tetracycline,Capsules

Tetracycline Hydrochloride
Ph Eur

2,346 TAN 07,530 J03B NOR

North China
Pharmaceutical Fomulation
Co. Ltd.
CHINA

Amoxicillin,Capsules

Amoxycillin Trihydrate Ph
Eur

2,344 TAN 07,527 J01H NOR

Manufacturer

North China
Pharmaceutical
CHINA

Ampicillin,Capsules
North China
Pharmaceutical Fomulation
Co. Ltd.
CHINA

Paracetamol,Tablet

Page 369 of 584

North China
Pharmaceutical
CHINA

Human Medicinal Products


S/No:

Registration Number

2,349 TAN 10, 085 M02A NOR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Diclofenac Sodium,Injectable
Solution

Diclofenac Sodium Ph Eur

2,350 TZ10H097

2,351 TZ10H098

2,352 TZ10H099

Amoxicillin Trihydrate eq to 125 mg/5ml


Amoxicillin Ph Eur

36

2,354 TAN 00,1146 C01K NOP

Cefalexin Monohydrate USP 250 mg

36

North China
Pharmaceutical Group
Corporation
CHINA

North China
Pharmaceutical Group
Corporation
CHINA

Diclofenac Sodium,Tablets
50 mg

36

25 mg

36

North China
Pharmaceutical
CHINA

Indomethacin,Capsules
North China
Pharmaceutical
CHINA

Norvatis Pharma Services Inc. - SWITZERLAND


Brinerdin,Tablet

Clopamide IH
Dihydroergocristine IH
Reserpine USP

Registrant

North China
Pharmaceutical
CHINA

Cefalexin,Capsules

Indomethacin Ph Eur

Registrant

36

Manufacturer

Amoxicillin,Suspension

Diclofenac Sodium Ph Eur

2,353 TZ10H096

75 mg/3ml

Shelf life
month

5 mg
0.5 mg
0.1 mg

Novartis Consumer Health SA - SWITZERLAND

Page 370 of 584

36

Norvatis Pharma AG.


SWITZERLAND

Human Medicinal Products


S/No:

Registration Number

2,355 TAN 00,4570 D04A NOV

2,356 TAN 00,4245 R01A NOV

2,357 TAN 00,4247 R01A NOV

2,358 TAN 00,4248 R05D NOV

Product Name
Pack and Pack size

Ingredient(s) and Strength

Crotamiton IH

10 %w/w

60

Xylometazoline
Hydrochloride IH

0.1 %w/v

36

Xylometazoline
Hydrochloride IH

0.05 mg/ml

36

2,361 TAN 05,677 R06A NOV

Novartis Consumer Health


SA
SWITZERLAND

Otrivin,Solution
Novartis Consumer Health
SA
SWITZERLAND

Otrivin,Solution
Novartis Consumer Health
SA
SWITZERLAND

Ca C Sandoz,Tablet

Calcium-Sandoz Forte
500,Tablet

Calcium Carbonate Ph Eur 300 mg


Calcium Lactate-gluconate 2.94 g
Ph Eur

2,360 TAN 05,676 C05A NOV

Manufacturer

Eurax,Cream

Calcium Carbonate Ph Eur 0.327 g


1g
Ascorbic Acid Ph Eur
Calcium Lactate-gluconate 1 g
Ph Eur
2,359 TAN 05,675 A12A NOV

Shelf life
month

36

36

Famar (Novartis Pharma


SA)
FRANCE

Novartis Consumer Health


SA
SWITZERLAND

Procto Glyvenol,Cream

Lidocaine Hydrochloride Ph 2 %w/w


Eur
5 %w/w
Tribenoside IH

60

Novartis Pharma GmbH


GERMANY

Clemestine Fumarate
1 mg
equivalent to Clemestine Ph
Eur

60

Novartis Pharma GmbH


GERMANY

Tavegyl,Tablet

Page 371 of 584

Human Medicinal Products


S/No:

Registration Number

2,362 TAN 06,092 R01A NOV

2,363 TAN 06,424 R01A NOV

Registrant
2,364 TAN 00,4408 C01E NOV

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,365 TAN 09,054 C01E NOV

2,366 TAN 09,055 C01E NOV

2,367 TAN 09,056 M03B NOV

Manufacturer

Otrivin,Spray

Xylometazoline
Hydrochloride EP

0.1 %w/v

36

Xylometazoline
Hydrochloride Ph Eur

0.1 %w/w

36

Novartis Consumer Health


SA
SWITZERLAND

Otrivin,Gel
Novartis Consumer Health
SA
SWITZERLAND

Novartis Pharma GmbH - GERMANY


Diovan,Tablet

Valsartan IH

Registrant

Shelf life
month

80 mg

24

Novartis Pharma GmbH


GERMANY

Novartis Pharma Services Inc - KENYA


Co-Diovan,Tablet
Norvatis Pharma Services
Inc.
SWITZERLAND

Hydrochlorthiazide IH
Valsartan IH

12.5 mg
160 mg

24

Hydrochlorthiazide Ph Eur
Valsartan Ph Eur

5 mg
80 mg

24

Novartis Pharma Stein AG


SWITZERLAND

60

Novartis Pharma GmbH


GERMANY

Co-Diovan,Tablet

Sirdalud,Tablet

Tizanidine Hydrochloride IH 2 mg

Page 372 of 584

Human Medicinal Products


S/No:

Registration Number

2,368 TAN 09,057 N03A NOV

2,369 TAN 09,057 N03A NOV

2,370 TAN 09,184 C01E NOV

2,371 TAN 09,185 C01E NOV

Registrant
2,372 TAN 00,1143 C01A NOP

2,373 TAN 00,1154 D06B NOP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Tegretol,Tablet
Novartis Farma S.p.A
ITALY

Carbamazepine
Ph.Eur/USP

100 mg

60

Carbamazepine Ph Eur

200 mg

60

Valsartan IH

80 mg

36

Novartis Farmaceutica S.A


SPAIN

Valsartan IH

160 mg

36

Novartis Farmaceutica S.A


SPAIN

Tegretol,Tablet
Norvatis Pharmaceuticals
Uk Ltd.
UNITED KINGDOM

Diovan,Tablet

Diovan,Tablet

Novartis Pharma Services Inc. - SWITZERLAND


Visken,Tablet

Pindololum BP

5 mg

60

Diclofenac Sodium IH

1 g/100g

36

Novartis Pharma Services


Inc.
SWITZERLAND

Voltaren,Cream

Page 373 of 584

Novartis Pharma Services


Inc.
SWITZERLAND

Human Medicinal Products


S/No:

Registration Number

2,374 TAN 06,201 N03A NOV

2,375 TAN 06,199 D01B NOV

2,376 TAN 06,202 M01A NOP

2,377 TAN 06,200 M01A NOV

2,378 TAN 05,042 N03A NOP

2,379 TAN 00,1142 M01A NOP

2,380 TAN 00,1144 R03A NOP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Tegretol,Tablet
Novartis Farma S.p.A
ITALY

Carbamazepine Ph Eur

100 mg

60

Terbinafine Hydrochloride
IH

125 mg

36

Diclofenac Sodium IH

75 mg/3ml

24

Novartis Pharma Stein AG


SWITZERLAND

Diclofenac Sodium IH

0.5 mg/drop

36

Norvatis Pharma S.A,


FRANCE

Carbamazepine IH

100 mg/5ml

60

Diclofenac Sodium IH

50 mg

60

Ketotifen Fumarate IH

1 mg/5ml

36

Lamisil,Tablet
Norvatis Pharmaceuticals
Uk Ltd.
UNITED KINGDOM

Voltaren,Injectable Solution

Cataflam,Solution

Tegretol,Syrup
Novartis Pharma Services
Inc.
SWITZERLAND

Voltaren,Tablet
Novartis Pharma Stein AG
SWITZERLAND

Zaditen,Syrup

Page 374 of 584

Famar (Novartis Pharma


SA)
FRANCE

Human Medicinal Products


S/No:

Registration Number

2,381 TAN 00,1147 D01A NOP

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,383 TAN 00,1149 B04A NOP

2,384 TAN 00,1150 J02A NOP

2,385 TAN 00,1151 L02B NOP

60

Novartis Pharma GmbH


GERMANY

Anafranil Hydrochloride BP 25 mg

60

Novartis Farma S.p.A


ITALY

Fluvastatin IH

20 mg

36

Terbinafine Hydrochloride
IH

250 mg

36

10 mg/g

Anafranil,Tablet

Lescol,Tablet

2,387 TAN 00,1154 R03A NOP

Novartis Pharma Services


Inc.
SWITZERLAND

Lamisil,Tablet
Novartis Pharma Services
Inc.
SWITZERLAND

Parlodel,Tablet
36

Novartis Farma S.p.A


ITALY

Hydralazine Hydrochloride 20 mg/2ml


IH

36

Novartis Pharma Stein AG


SWITZERLAND

Ketotifen Hydrogen
Fumarate equivalent to
Ketotifen IH

60

Bromocriptine Mesylate USP 2.5 mg

2,386 TAN 00,1152 C04A NOP

Manufacturer

Lamisil,Cream

Terbinafine Hydrochloride
IH

2,382 TAN 00,1148 N05A NOP

Shelf life
month

Apresolin,Injectable Solution

Zaditen,Tablet

Page 375 of 584

1 mg

Norvatis Pharmaceuticals
Uk Ltd.
UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

2,388 TAN 06,321 M01A NOP

2,389 TAN 06,322 M01A NOV

2,390 TAN 07,088 B04A NOP

2,391 TAN 07,086 N03A NOV

2,392 TAN 07,087 C01K NOP

2,393 TAN 07,209 C01K NOP

2,394 TAN 07,206 C01K NOP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Voltaren SR 75,Tablet

Voltfast,Powder for
Suspension

Shelys Pharmaceuticals
Ltd.
TANZANIA

Diclofenac Sodium NA

75 mg

36

Diclofenac Potassium IH

50 mg

24

Mipharm S.P.A
ITALY

Fluvastatin Sodium Ph Eur 80 mg

24

Novartis Farmaceutica S.A


SPAIN

Lescol XL,Tablet

Tegretol CR 200,Tablet

Carbamazepine Ph Eur

200 mg

36

Novartis Farma S.p.A


ITALY

Amlodipine Besylate IH
Valsartan IH

10 mg
160 mg

36

Novartis Pharma Stein AG


SWITZERLAND

Amlodipine Besylate IH
Valsartan IH

5 mg
160 mg

24

Novartis Pharma Stein AG


SWITZERLAND

Amlodipine Besylate IH
Valsartan IH

10 mg
160 mg

24

Novartis Pharma Stein AG


SWITZERLAND

Exforge,Tablet

Exforge,Tablet

Exforge,Tablet

Page 376 of 584

Human Medicinal Products


S/No:

Registration Number

2,395 TAN 07,207 M03B NOP

2,396 TAN 07,208 M03B NOP

2,397 TAN 00,1666 N02B NOP

2,398 TAN 07,358 V07A NOP

2,399 TAN 07,359 V07A NOP

2,400 TAN 07,360 C01E NOP

2,401 TAN 07,357 N03A NOP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Sirdalud,Tablet

Tizanidine Hydrochloride IH 2 mg

24

Novartis Pharma GmbH


GERMANY

Tizanidine Hydrochloride IH 4 mg

24

Novartis Pharma GmbH


GERMANY

Diclofenac Potassium Ph
Eur

50 mg

60

Aliskiren IH

150 mg

24

Aliskiren IH

300 mg

24

Valsartan IH

320 mg

24

Carbamazepine IH

400 mg

36

Sirdalud,Tablet

Cataflam,Tablet
Novartis Pharma Services
Inc.
SWITZERLAND

Rasilez,Tablet
Novartis Pharma Services
Inc.
SWITZERLAND

Rasilez,Tablet
Novartis Pharma Services
Inc.
SWITZERLAND

Diovan,Tablet
Novartis Pharma Services
Inc.
SWITZERLAND

Tegretol CR,Tablet

Page 377 of 584

Novartis Pharma Services


Inc.
SWITZERLAND

Human Medicinal Products


S/No:

Registration Number

2,402 TAN 08,019 J05A NOP

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,403 TAN 05,798 C01E NOV

2,404 TAN 05,797 C01K NOV

2,405 TAN 05,796 C01K NOV

Registrant
2,406 TAN 00,221 A01A NOV

2,407 TAN 00,220 A01A NOV

Manufacturer

Sebivo,Tablet

Telbivudine IH

Registrant

Shelf life
month

600 mg

24

Novartis Pharma Stein AG


SWITZERLAND

Novartis Pharma Stein AG - SWITZERLAND


Diovan,Tablet

Valsartan IH

160 mg

24

Novartis Pharma Stein AG


SWITZERLAND

Hydrochlorthiazide IH
Valsartan IH

25 mg
160 mg

24

Novartis Pharma Stein AG


SWITZERLAND

Hydrochlorthiazide IH
Valsartan IH

12.5 mg
80 mg

24

Novartis Pharma Stein AG


SWITZERLAND

Human Insulin IH

100 IU

30

Novo Nordisk A/S


DENMARK

Human Insulin Ph Eur


Isophane Insulin Ph Eur

70 IU
30 IU

30

Novo Nordisk A/S


DENMARK

Co Diovan,Tablet

Co Diovan,Tablet

Novo Nordisk A/S - GREECE


Insulatard,Suspension

Mixtard,Solution

Page 378 of 584

Human Medicinal Products


S/No:

Registration Number

2,408 TAN 00,228 A10A NOV

2,409 TAN 00,222 A10A NOV

Product Name
Pack and Pack size
Insulatard HM
Penfill,Injection

Ingredient(s) and Strength

30

Novo Nordisk A/S


DENMARK

100 IU/ml

30

Novo Nordisk A/S


DENMARK

40 IU/ml

36

Novo Nordisk A/S


DENMARK

100 IU

30

Novo Nordisk A/S


DENMARK

Human Insulin IH

100 IU

30

Novo Nordisk A/S


DENMARK

Human Insulin Ph Eur


Isophane Insulin Ph Eur

70 IU
30 IU

30

Novo Nordisk A/S


DENMARK

Human Insulin Ph Eur

100 IU/10ml

30

Novo Nordisk A/S


DENMARK

Actrapid,Suspension

Actrapid,Suspension

Human Insulin Ph Eur

2,411 TAN 00,221 A01A NOV

Insulatard,Suspension

Human Insulin IH

2,412 TAN 00,221 A01A NOV

2,413 TAN 00,220 A01A NOV

2,414 TAN 00,228 A10A NOV

Manufacturer

100 IU/10ml

Human Insulin Ph Eur

Human Insulin Ph Eur

2,410 TAN 00,223 A10A NOV

Shelf life
month

Insulatard,Suspension

Mixtard,Solution

Insulatard HM
Penfill,Injection

Page 379 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
2,415 TAN 00,224 A10A NOV

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,417 TAN 00,795 A10A NOV

2,418 TAN 00,224 A10A NOV

Actrapid HM,Suspension
100 IU/ml

30

Novo Nordisk A/S


DENMARK

Human Insulin Ph Eur

100 IU/ml

30

Novo Nordisk A/S


DENMARK

Human Insulin Ph Eur

100 IU/ml

30

Novo Nordisk A/S


DENMARK

100 IU/ml

30

Novo Nordisk A/S


DENMARK

100 IU/ml

30

Novo Nordisk A/S


DENMARK

100 IU/ml

30

Novo Nordisk A/S


DENMARK

Actrapid HM,Suspension

Mixtard,Injection

Actrapid HM,Suspension

Human Insulin Ph Eur

2,419 TAN 00,224 A10A NOV

Actrapid HM,Suspension

Human Insulin Ph Eur

2,420 TAN 00,225 A10A NOV

Manufacturer

Novo Nordisk(pty) Ltd. - SOUTH AFRICA


Human Insulin Ph Eur

2,416 TAN 00,225 A10A NOV

Shelf life
month

Actrapid HM,Suspension

Human Insulin Ph Eur

Page 380 of 584

Human Medicinal Products


S/No:

Registration Number

2,421 TAN 00,225 A10A NOV

2,422 TAN 00,795 A10A NOV

Registrant
2,423 TZ11H159

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,424 TAN 05,121 A02C MER

Human Insulin Ph Eur

100 IU/ml

30

Novo Nordisk A/S


DENMARK

Human Insulin Ph Eur

100 IU/ml

30

Novo Nordisk A/S


DENMARK

4 mg

36

200 mg

24

1000 mg/20ml

24

250 mg/10ml

24

Mixtard,Injection

Nycomed (Pty) Ltd - GERMANY


Alvesco 160,Inhaler

2,425 TAN 05,045 J01D ORC

Alom,Tablet
Windlas Biotech Ltd.
INDIA

Orchid Healthcare - INDIA


Cefogram,Injectable Solution

Ceftriaxone Sodium USP

2,426 TAN 05,043 J01D ORC

NYCOMED ORANIENBURG
GmmbH
GERMANY

Ocean Medicare Ltd. - TANZANIA


Albendazole BP

Registrant

Manufacturer

Actrapid HM,Suspension

Ciclesonide IH

Registrant

Shelf life
month

Astral Pharmaceutical
Industries
INDIA

Orzid,Powder for Injection

Ceftazidime Pentahydrate
USP

Page 381 of 584

Astral Pharmaceutical
Industries
INDIA

Human Medicinal Products


S/No:

Registration Number

2,427 TAN 05,046 J01D ORC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Tax O-Bid,Powder for


Injection

Cefotaxime Sodium USP

2,428 TAN 05,044 J01D ORC

Tax O-Bid,Powder for


Injection

Cefotaxime Sodium USP

2,429 TAN 05,678 J01D ORC

2,431 TAN 07,094 M01A OKA

1000 mg/5ml

24

750 mg/15ml

24

1000 mg/20ml

24

Astral Pharmaceutical
Industries
INDIA

Astral Pharmaceutical
Industries
INDIA

Astral Pharmaceutical
Industries
INDIA

Astral Pharmaceutical
Industries
INDIA

OSCAR ERNEST MGIMBE - TANZANIA


Akaran-SR,Tablet

Diclofenac Sodium IH

2,432 TAN 07,361 J01D OKA

24

Orzid,Powder for Injection

Ceftazidime Pentahydrate
USP

Registrant

500 mg

Manufacturer

Spizef,Powder for Injection

Cefuroxime Sodium USP

2,430 TAN 05,078 J01D ORC

Shelf life
month

Oka-Ceftriaxone,Powder for
Injection

Ceftriaxone Sodium
equivalent to Ceftriaxone
USP

Page 382 of 584

100 mg

36

Okasa Pharma Pvt. Ltd


INDIA

1g

24

OSCAR ERNEST MGIMBE


TANZANIA

Human Medicinal Products


S/No:

Registration Number

2,433 TAN 07,362 J01D OKA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Oka-Ceftriaxone,Powder for
Injection

24

OSCAR ERNEST MGIMBE


TANZANIA

75 mg
97.85 mg

24

OSCAR ERNEST MGIMBE


TANZANIA

1 mg/ml

18

Okasa Pharma Pvt. Ltd


INDIA

Fexofenadine Hydrochloride 120 mg


BP

36

Pacific Pharmaceutical Ltd.


PAKISTAN

Fexofenadine Hydrochloride 60 mg
BP

36

Pacific Pharmaceutical Ltd.


PAKISTAN

Metoclopramide
Hydrochloride BP
Sodium Dehydrocholate IH
Bromelain IH
Simethicone USP
Pancreatin USP

36

Pacific Pharmaceutical Ltd.


PAKISTAN

Clopicard AP,Tablet

Acetylsalicylic Acid IH
Clopidogrel Bisulfate IH

2,435 TAN 09,186 L01C OKA

Oka Vincristine
Aqueous,Injectable Solution

Vincristine Sulphate USP

Registrant
2,436 TAN 06,426 R06A PAC

2,437 TAN 06,425 R06A PAC

2,438 TAN 07,366 A09A PAC

Manufacturer

250 mg

Ceftriaxone Sodium
equivalent to Ceftriaxone
USP

2,434 TAN 07,532 B01A OKA

Shelf life
month

Pacific Pharmaceutical Ltd. - PAKISTAN


Novahist,Tablet

Novahist,Tablet

Plasenzym,Tablet

Page 383 of 584

6 mg
20 mg
3500 unit
50 mg
210 unit

Human Medicinal Products


S/No:

Registration Number

2,439 TAN 07,363 D01A PAC

2,440 TAN 07,365 A04A PAC

2,441 TAN 07,364 D01A PAC

2,442 TAN 09,032 A01A PAC

Registrant
2,443 TAN 05,199 J01K PAN

2,444 TAN 05,198 J01K PAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Lomexin,Cream
36

Pacific Pharmaceutical Ltd.


PAKISTAN

Plasil,Tablet

Metoclopramide
Hydrochloride BP

10 mg

36

Pacific Pharmaceutical Ltd.


PAKISTAN

Fenticonazole Nitrate BP

2 %w/w

36

Pacific Pharmaceutical Ltd.


PAKISTAN

Tibezonium Iodide BP

5 mg

36

Pacific Pharmaceutical Ltd.


PAKISTAN

Levofloxacin IH

250 mg

36

Panacea Biotec Ltd.


INDIA

Levofloxacin Hemihydrate
IH

500 mg

36

Panacea Biotec Ltd.


INDIA

Lomexin,Cream

Tyzorin,Lozenges

Panacea Biotec Ltd. - INDIA


Voxin,Tablet

Voxin-500,Tablet

Page 384 of 584

Human Medicinal Products


S/No:

Registration Number

2,445 TAN 05,197 G03D PAN

2,446 TAN 05,198 J01K PAN

2,447 TAN 00,806 A06A PAN

2,448 TAN 00,446 J01F PAN

2,449 TAN 00,805 R05E PAN

2,450 TAN 00,805 R05E PAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Osral,Tablet

Raloxifene IH

60 mg

36

Panacea Biotec Ltd.


INDIA

Levofloxacin Hemihydrate
IH

500 mg

36

Panacea Biotec Ltd.


INDIA

Lactulose USP

3.325 g/5ml

48

Panacea Biotec Ltd.


INDIA

Ciprofloxacin USP

500 mg

36

Panacea Biotec Ltd.


INDIA

Phenylephrine
Hydrochloride BP
Chlorpheniramine Maleate
BP
Paracetamol BP
Dextromethorphan
Hydrobromide BP

10 mg

36

Panacea Biotec Ltd.


INDIA

Phenylephrine
Hydrochloride BP
Chlorpheniramine Maleate
BP
Paracetamol BP
Dextromethorphan
Hydrobromide BP

10 mg

36

Panacea Biotec Ltd.


INDIA

Voxin-500,Tablet

Livoluk,Solution

Cipropan,Tablet

Toff plus,Capsules

2 mg
500 mg
15 mg

Toff plus,Capsules

Page 385 of 584

2 mg
500 mg
15 mg

Human Medicinal Products


S/No:

Registration Number

2,451 TAN 00,447 J01F PAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,452 TAN 06,094 D08A PFI

2,453 TAN 00,930 B04A WAR

2,454 TAN 00,1286 N03A WAR

2,455 TAN 00,2183 J02A PFI

2,456 TZ10H126

36

Panacea Biotec Ltd.


INDIA

Pfizer Global Manufacturing, A Division of Pfizer - SOUTH AFRICA


Listerine,Solution
Pfizer Global
Manufacturing, A Division
of Pfizer
SOUTH AFRICA

12.78 mg/20ml
4.54 ml/20ml

36

Atorvastatin Calcium
Trihydrate IH

10 mg

36

Pfizer Laboratories
KENYA

Phenytoin Sodium USP

100 mg

36

Twiga Chemical Industries


TANZANIA

Fluconazole IH

200 mg

24

Pfizer Pharmaceuticals LLC


PUERTO RICO

36

Pharmacia Ltd.
ITALY

Thymol IH
Alcohol USP

Registrant

Manufacturer

Cipropan,Tablet

Ciprofloxacin Hydrochloride 250 mg


USP

Registrant

Shelf life
month

Pfizer Laboratories - KENYA


Lipitor,Tablet

Epanutin,Capsules

Diflucan,Tablet

Farmorubicin 50MG,Powder

Epirubicin Hydrochloride BP 50 mg

Page 386 of 584

Human Medicinal Products


S/No:

Registration Number

2,457 TZ10H127

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,458 TAN 00,808 J01K PFI

2,459 TAN 00,1162 J02A PFI

2,460 TAN 00,1163 J02A PFI

2,461 TAN 00,1164 J02A PFI

2,462 TAN 00,1165 C01K PFL

Manufacturer

Farmorubicin 10MG,Powder

Epirubicin Hydrochloride BP 10 mg

Registrant

Shelf life
month

48

Pharmacia Ltd.
ITALY

Pfizer Laboratories (Pty) Ltd. - SOUTH AFRICA


Zithromax,Tablet

Azithromycin Dihydrate
equivalent to Azithromycin
IH

500 mg

24

Pfizer Laboratories (Pty) Ltd.


SOUTH AFRICA

Fluconazole IH

50 mg

60

Laboratoire Pfizer
FRANCE

Fluconazole IH

150 mg

60

Laboratoire Pfizer
FRANCE

Fluconazole IH

200 mg

60

Laboratoire Pfizer
FRANCE

Amlodipine Besylate IH

5 mg

48

Laboratoire Pfizer
FRANCE

Diflucan,Capsules

Diflucan,Capsules

Diflucan,Capsules

Norvasc,Tablet

Page 387 of 584

Human Medicinal Products


S/No:

Registration Number

2,463 TAN 00,1167 A10B PFI

Product Name
Pack and Pack size

Ingredient(s) and Strength

250 mg

24

Pfizer Laboratories (Pty) Ltd.


SOUTH AFRICA

2 mg/ml

60

Laboratoire Pfizer
FRANCE

230 mg/5ml

36

2 g/60ml

36

Pfizer Pharmaceuticals LLC


PUERTO RICO

Azithromycin Dihydrate
equivalent to Azithromycin
IH

200 mg/5ml

24

Pfizer Laboratories (Pty) Ltd.


SOUTH AFRICA

Sildenafil Citrate IH

50 mg

60

Pfizer Laboratories
KENYA

Maraviroc IH

150 mg

24

Godecke GMbH,
GERMANY

Diflucan IV,Solution

Fluconazole IH

2,465 TAN 00,1285 N03A WAR

Epanutin Ready Mixed


Parenteral,Injectable Solution

Phenytoin Sodium USP

2,466 TAN 07,210 J01F PFI

2,468 TAN 00,2184 C04A PFI

2,469 TZ10H075

Warner-Lambert S.A (Pty)


Ltd.
SOUTH AFRICA

Zmax,Powder for Suspension

Azithromycin Dihydrate eq
to Azithromycin IH

2,467 TAN 00,807 J01K PFI

Manufacturer

Diabenese,Tablet

Chlorpropamide IH

2,464 TAN 00,1473 J02A PFI

Shelf life
month

Zithromax,Suspension

Viagra,Tablet

Celsentri,Tablets

Page 388 of 584

Human Medicinal Products


S/No:

Registration Number

2,470 TZ10H076

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,472 TAN 00,2184 C04A PFI

2,473 TAN 00,807 J01K PFI

300 mg

24

Godecke GMbH,
GERMANY

Azithromycin Dihydrate
equivalent to Azithromycin
IH

200 mg/5ml

24

Pfizer Italiana SpA


ITALY

Sildenafil Citrate IH

50 mg

60

Pfizer Laboratories
KENYA

200 mg/5ml

24

Pfizer Italiana SpA


ITALY

Azithromycin Dihydrate
equivalent to Azithromycin
IH

200 mg/5ml

24

Pfizer Italiana SpA


ITALY

Sildenafil Citrate IH

50 mg

60

Pfizer Laboratories
KENYA

Sildenafil Citrate IH

50 mg

60

Pfizer Laboratories
KENYA

Zithromax,Suspension

Viagra,Tablet

Zithromax,Suspension

Azithromycin Dihydrate
equivalent to Azithromycin
IH
2,474 TAN 00,807 J01K PFI

2,475 TAN 00,2184 C04A PFI

2,476 TAN 00,2184 C04A PFI

Manufacturer

Celsentri,Tablets

Maraviroc IH

2,471 TAN 00,807 J01K PFI

Shelf life
month

Zithromax,Suspension

Viagra,Tablet

Viagra,Tablet

Page 389 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
2,477 TAN 00,2597 A10B PFI

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,478 TAN 00,2367 G01A PHR

2,479 TAN 00,2368 A06A PHR

2,480 TAN 00,2599 A04A PHR

2,481 TAN 00,4320 M01A PHR

2,482 TAN 00,4322 D07A PHR

Diabinese,Tablet
250 mg

24

Laboratories Pfizer LTDA-SP


BRAZIL

Pharaonia Pharmaceuticals - EGYPT


Monicure,Pessaries

Miconazole Nitrate USP

200 mg

36

Pharaonia Pharmaceuticals
EGYPT

Sodium Picosulphate BP

7.5 mg/ml

36

Pharaonia Pharmaceuticals
EGYPT

Pyridoxine Hydrochloride
BP
Meclizine Hydrochloride
USP

50 mg

36

Pharaonia Pharmaceuticals
EGYPT

Ketoprofen IH

50 mg

36

Pharaonia Pharmaceuticals
EGYPT

0.1 mg/g

36

Pharaonia Pharmaceuticals
EGYPT

Normalax,Solution

Vomidoxine,Tablet

25 mg

Ketogesic,Capsules

Betamethasone,Ointment

Betamethasone Valerate
USP

Registrant

Manufacturer

Pfizer NV - BELGIUM
Chlorpropamide IH

Registrant

Shelf life
month

Pharco Pharmaceutical - EGYPT


Page 390 of 584

Human Medicinal Products


S/No:

Registration Number

2,483 TAN 00,573 G01A PHP

2,484 TAN 00,574 G01A PHP

2,485 TAN00,2373A 11A PHP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Gynozol,Cream

Miconazole Nitrate BP

2 %w/w

36

Pharco Pharmaceuticals
EGYPT

Miconazole Nitrate BP

400 mg

36

Pharco Pharmaceuticals
EGYPT

Gynozol,Pessaries

V2 Plus,Capsules

Page 391 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Calcium Phosphate BP
Ascorbic Acid BP
Calcium D-Pantothenate BP
Cholecalciferol USP
Copper Sulphate IH
Cyanocobalamin BP
D(+) Biotin USP
Essential Phospolipids IH
Folic Acid BP
Ginseng Extract USP
Inositol IH
Iron BP
Magnesium BP
Manganese USP
Molybdenum IH
Nicotinamide BP
Potasium Iodide IH
Potassium Chloride BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Riboflavin Sodium
Phosphate BP
Sunflower Oil IH
Thiamine Hydrochloride BP
Tocopheryl Acetate
Nicotinamide
Dexapanthenol BP
Vitamin A Ph Eur
Zinc USP
2,486 TAN 00,809 R03B PHP

Manufacturer

36

Pharco Pharmaceuticals
EGYPT

1 mg

36

Pharco Pharmaceuticals
EGYPT

100 mg

36

Pharco Pharmaceuticals
EGYPT

88.2 mg
75 mg
5 mg
400 IU
1 mg
3 mcg
0.015 mg
10 mg
0.4 mg
50 mg
40 mg
10 mg
6 mg
1 mg
0.2 mg
25 mg
5 mg
0.15 mg
2 mg
5 mg
200 mg
5 mg
30 mg

1000 IU
1.2 mg

Ketoti Pharco,Tablet

Ketotifen IH

2,487 TAN 00,810 J01A PHP

Shelf life
month

Farcodoxin,Capsules

Doxycycline Hydrochloride
BP

Page 392 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

2,488 TAN 00,811 A11C PHP

Vitamin A,Capsules

2,489 TAN 00,813 D01A PHP

2,490 TAN 00,1170 A10B PHP

2,491 TAN 00,573 G01A PHP

2,492 TAN 00,573 G01A PHP

2,493 TAN 00,574 G01A PHP

2,494 TAN 00,574 G01A PHP

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Vitamin A Ph Eur

50000 IU

36

Pharco Pharmaceuticals
EGYPT

Miconazole BP

2 g/100g

36

Pharco Pharmaceuticals
EGYPT

Glibenclamide BP

5 mg

36

Pharco Pharmaceuticals
EGYPT

Miconazole Nitrate BP

2 %w/w

36

Pharco Pharmaceuticals
EGYPT

Miconazole Nitrate BP

2 %w/w

36

Pharco Pharmaceuticals
EGYPT

Miconazole Nitrate BP

400 mg

36

Pharco Pharmaceuticals
EGYPT

Miconazole Nitrate BP

400 mg

36

Pharco Pharmaceuticals
EGYPT

Dermozol,Gel

Diaben,Tablet

Gynozol,Cream

Gynozol,Cream

Gynozol,Pessaries

Gynozol,Pessaries

Page 393 of 584

Human Medicinal Products


S/No:

Registration Number

2,495 TAN00,2373A 11A PHP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

V2 Plus,Capsules

Calcium Phosphate BP
Ascorbic Acid BP
Calcium D-Pantothenate BP
Cholecalciferol USP
Copper Sulphate IH
Cyanocobalamin BP
D(+) Biotin USP
Essential Phospolipids IH
Folic Acid BP
Ginseng Extract USP
Inositol IH
Iron BP
Magnesium BP
Manganese USP
Molybdenum IH
Nicotinamide BP
Potasium Iodide IH
Potassium Chloride BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Riboflavin Sodium
Phosphate BP
Sunflower Oil IH
Thiamine Hydrochloride BP
Tocopheryl Acetate
Nicotinamide
Dexapanthenol BP
Vitamin A Ph Eur
Zinc USP
2,496 TAN00,2373A 11A PHP

Shelf life
month

V2 Plus,Capsules

Page 394 of 584

88.2 mg
75 mg
5 mg
400 IU
1 mg
3 mcg
0.015 mg
10 mg
0.4 mg
50 mg
40 mg
10 mg
6 mg
1 mg
0.2 mg
25 mg
5 mg
0.15 mg
2 mg
5 mg
200 mg
5 mg
30 mg

1000 IU
1.2 mg

36

Pharco Pharmaceuticals
EGYPT

Human Medicinal Products


S/No:

Registration Number

2,497 TAN 00,811 A11C PHP

2,498 TAN 00,811 A11C PHP

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

36

Pharco Pharmaceuticals
EGYPT

50000 IU

36

Pharco Pharmaceuticals
EGYPT

50000 IU

36

Pharco Pharmaceuticals
EGYPT

Calcium Phosphate BP
Ascorbic Acid BP
Calcium D-Pantothenate BP
Cholecalciferol USP
Copper Sulphate IH
Cyanocobalamin BP
D(+) Biotin USP
Essential Phospolipids IH
Folic Acid BP
Ginseng Extract USP
Inositol IH
Iron BP
Magnesium BP
Manganese USP
Molybdenum IH
Nicotinamide BP
Potasium Iodide IH
Potassium Chloride BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Riboflavin Sodium
Phosphate BP
Sunflower Oil IH
Thiamine Hydrochloride BP
Tocopheryl Acetate
Nicotinamide
Dexapanthenol BP
Vitamin A Ph Eur
Zinc USP

88.2 mg
75 mg
5 mg
400 IU
1 mg
3 mcg
0.015 mg
10 mg
0.4 mg
50 mg
40 mg
10 mg
6 mg
1 mg
0.2 mg
25 mg
5 mg
0.15 mg
2 mg

Vitamin A Ph Eur

Vitamin A Ph Eur

5 mg
200 mg
5 mg
30 mg

1000 IU
1.2 mg

Vitamin A,Capsules

Vitamin A,Capsules

Page 395 of 584

Human Medicinal Products


S/No:

Registration Number

2,499 TAN 07,213 V07A PHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,504 TAN 05,800 D07A PHA

36

Pharco Pharmaceutical
EGYPT

100 mg

36

Micro Labs Ltd.


INDIA

2.8 g/5g
1.33 g/5g
0.82 g/5g
7.6 g/5g
42.4 g/5g

24

Pharco Pharmaceutical
EGYPT

30000 IU
70 mg

36

Pharco Pharmaceutical
EGYPT

Vitamin A & E,Capsules

Vitamin A Ph Eur
Vitamin E Ph Eur

Registrant

5 mg/5ml

30 mg
100 mg
36 mg
100 mg

Fawar Fruit,Granules

Sodium Bicarbonate Ph Eur


Tartaric Acid Ph Eur
Citric Acid Hydrous Ph Eur
Saccharin Sodium Ph Eur
Tutti Frutti Ph Eur
2,503 TAN 07,367 A11A PHA

Pharco Pharmaceutical
EGYPT

Declophan SR 100,Capsules

Diclofenac Sodium BP

2,502 TAN 07,214 A02A PHA

36

5 mg

Farcotilium,Suspension

Domperidone Ph Eur

2,501 TAN 07,211 M01A PHA

Manufacturer

Spasmo Digestin,Tablet

Dicyclomine Hydrochloride
Ph Eur
Simethicone Ph Eur
Sodium Dehydrocholate IH
Sanzyme IH
Papain USP
2,500 TAN 07,212 A04A PHA

Shelf life
month

Pharma International Company, - JORDAN


Delor,Cream

Clobetasol Propionate USP

Page 396 of 584

0.05 %w/w

24

Pharma International
Company,
JORDAN

Human Medicinal Products


S/No:

Registration Number

2,505 TAN 05,799 R06A PHA

2,506 TAN 05,802 J01D PHA

2,507 TAN 05,803 J02A PHA

2,508 TAN 05,804 D04A PHA

2,509 TAN 05,801 J01D PHA

2,510 TAN 05,806 D04A PHA

2,511 TAN 05,805 J01F PHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Finallerg,Tablet

Cetrizine Hydrochloride IH

10 mg

24

Cefpodoxime Proxetil USP

200 mg

24

Ketoconazole USP

2%

24

Loratadine IH

1%

24

Cefpodoxime Proxetil USP

100 mg/5ml

24

Loratadine IH

10 mg

24

Clarithromycin USP

500 mg

24

Pharma International
Company,
JORDAN

Cefodox,Tablet
Pharma International
Company,
JORDAN

Kenazole,Shampoo
Pharma International
Company,
JORDAN

Tidilor,Syrup
Pharma International
Company,
JORDAN

Cefodox,Suspension
Pharma International
Company,
JORDAN

Tidilor,Tablet
Pharma International
Company,
JORDAN

Clarix,Tablet

Page 397 of 584

Pharma International
Company,
JORDAN

Human Medicinal Products


S/No:

Registration Number

2,512 TAN 05,873 D07A PHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,513 TAN 09,190 J03B PHA

2,515 TAN 07,373 V07A PHA

2,516 TAN 07,368 A11E PHA

2,517 TAN 07,372 M01A PHA

0.0125 %w/v

24

Pharma International
Company,
JORDAN

Pharmaceutical Manufacturing Co.(K) Ltd. - KENYA


Trizole,Suspension

Sulfamethoxazole BP
Trimethoprim BP

2,514 TAN 07,371 D07A PHA

Manufacturer

Delor,Ointment

Clobetasol Propionate USP

Registrant

Shelf life
month

200 mg/5ml
40 mg/5ml

36

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Betason,Cream

Betamethasone Valerate BP 0.1 %w/w

36

Tretinoin BP

0.5 mg

36

Thiamine BP
Nicotinamide BP
Riboflavin BP

1 mg
15 mg
1 mg

24

Caffeine BP
Acetylsalicylic Acid BP

30 mg
350 mg

24

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Uniacne,Cream
Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Vitamin B Complex,Tablet
Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Gopain,Tablet

Page 398 of 584

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

2,518 TAN 07,374 D01A PHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,520 TAN 07,370 P01B PHA

2,521 TAN 07,378 H02A PHA

2,522 TAN 07,377 D01A PHA

2,523 TAN 07,533 R05C PHA

2,524 TAN 09,190 J03B PHA

Manufacturer

Unistatin,Suspension

Nystatin BP

2,519 TAN 07,376 M01A PHA

Shelf life
month

100000 Armour Units


IU

24

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Ibugesic,Suspension

Ibuprofen BP
Paracetamol BP

100 mg
125 mg

36

Pyrimethamine BP
Sulfadoxine BP

12.5 mg/5ml
250 mg/5ml

24

Prednisolone BP

5 mg

36

Clotrimazole BP

1 %w/w

24

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Unidar,Suspension
Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Prednisolone,Tablet
Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Clozole,Cream
Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Phencod,Syrup

Ephedrine Hydrochloride
7.5 mg/5ml
BP
8 mg/5ml
Dextromethorphan BP
Promethazine Hydrochloride 4 mg/5ml
BP

36

Sulfamethoxazole BP
Trimethoprim BP

36

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Trizole,Suspension

Page 399 of 584

200 mg/5ml
40 mg/5ml

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Human Medicinal Products


S/No:

Registration Number

2,525 TAN 09,188 R05A PHA

2,526 TAN 09,189 R05A PHA

2,527 TAN 10,039 A11A PHA

Registrant
2,528 TAN 09,196 B05B PHA

2,529 TAN 09,193 B05B PHA

2,530 TAN 09,193 B05B PHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Unicold,Syrup

Chlorpheniramine Maleate
BP
Paracetamol BP
Pseudoephedrine
Hydrobromide BP

2 mg/5ml

Diphenhydramine
Hydrochloride BP
Sodium Citrate BP
Ammonium Chloride BP

14 mg/5ml

Nicotinamide BP
Thiamine Hydrochloride BP
Ferric Ammonium Citrate
BP
Vitamin B12 BP
Riboflavin BP

5 mg/5ml
2 mg/5ml
200 mg/5ml

36

120 mg/5ml
10 mg/5ml

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Unised,Syrup
36

57 mg/5ml
135 mg/5ml

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Ferrovit,Syrup
36

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

2.5 mg/5ml
0.5 mg/5ml

Pharmaceutical Solution Industry (PSI) - SAUDI ARABIA


Sodium Chloride +
Dextrose,Solution

Dextrose BP
Sodium Chloride BP

5 %w/v
0.9 %w/v

60

Glucose Anhydrous BP

5 %w/v

36

Glucose Anhydrous BP

5 %w/v

36

Pharmaceutical Solution
Industry (PSI)
SAUDI ARABIA

Dextrose,Solution
Pharmaceutical Solution
Industry (PSI)
SAUDI ARABIA

Dextrose,Solution

Page 400 of 584

Pharmaceutical Solution
Industry (PSI)
SAUDI ARABIA

Human Medicinal Products


S/No:

Registration Number

2,531 TAN 09,196 B05B PHA

2,532 TAN 09,195 B05X PHA

Product Name
Pack and Pack size
Sodium Chloride +
Dextrose,Solution

Ingredient(s) and Strength

5 %w/v
0.9 %w/v

60

10 %w/v

60

50 %w/v

60

Sodium Chloride BP

0.9 %w/v

60

Dextrose BP
Sodium Chloride BP
Sodium Citrate BP
Potassium Citrate BP

27.5 g/L
2.045 g/L
0.98 g/L
2.162 g/L

60

Methylprednisolone Acetate 40 mg/ml


USP

60

Dextrose BP
Sodium Chloride BP

2,535 TAN 09,191 A07C PHA

Registrant
2,536 TAN 00,476 H02A PHA

Pharmaceutical Solution
Industry (PSI)
SAUDI ARABIA

Pharmaceutical Solution
Industry (PSI)
SAUDI ARABIA

Magnesium Sulphate,Solution

Magnesium Sulphate BP

2,534 TAN 09,192 B05B PHA

Manufacturer

Magnesium Sulphate,Solution

Magnesium Sulphate BP

2,533 TAN 09,194 B05X PHA

Shelf life
month

Pharmaceutical Solution
Industry (PSI)
SAUDI ARABIA

Sodium Chloride,Solution
Pharmaceutical Solution
Industry (PSI)
SAUDI ARABIA

Babylyte,Solution
Pharmaceutical Solution
Industry (PSI)
SAUDI ARABIA

Pharmacia & UpJohn - ITALY


Depo Medrol,Injectable
Solution

Page 401 of 584

Pharmacia Ltd.
BELGIUM

Human Medicinal Products


S/No:

Registration Number

2,537 TAN 00,476 H02A PHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Depo Medrol,Injectable
Solution

Hilton Pharma (PVT) Ltd.


PAKISTAN

0.005 %w/v

24

Pharmacia & UpJohn


BELGIUM

1.75 mg
2.5 mg

24

Patheon YM Inc
CANADA

Clindamycin Hydrochloride 300 mg


Ph Eur

60

Kela N.V
BELGIUM

Clindamycin Phosphate Ph 10 mg/ml


Eur

24

Xalatan,Ophthalmic Solution

Latanoprost Ph Eur

2,539 TAN 00,1477 H02B PHA

Neo Medrol Acne,Suspension

Neomycin Sulphate IH
Methylprednisolone Acetate
IH
Sulfidal USP
Aluminium Chloride
Compex Solution USP
2,540 TAN 00,470 J01F PHA

2,541 TAN 00,1672 D10A PHA

2,542 TAN 00,2026 H02A PHA

Manufacturer

60

Methylprednisolone Acetate 40 mg/ml


USP

2,538 TAN 00,815 S01D PHA

Shelf life
month

0.05 mg
200 mg

Dalacin C,Capsules

Dalacin T,Solution

Solu Medrol,Powder for


Injection

Methylprednisolone USP

Page 402 of 584

40 mg

60

Pfizer Manufacturing
Belgium NV
BELGIUM

Pharmacia Ltd.
BELGIUM

Human Medicinal Products


S/No:

Registration Number

2,543 TAN 00,2027 H02A PHA

2,544 TAN 00,472 J01F PHA

2,545 TAN 00,1475 J01K PHA

2,546 TAN 00,472 J01F PHA

2,547 TAN 00,472 J01F PHA

2,548 TAN 00,472 J01F PHA

Registrant

Product Name
Pack and Pack size

Ingredient(s) and Strength

Solu Medrol,Powder for


Injection

Shelf life
month

Manufacturer

Methylprednisolone USP

125 mg

60

Pharmacia Ltd.
BELGIUM

Clindamycin Palmitate
Hydrochloride USP

75 mg/5ml

60

Kela N.V
BELGIUM

Clindamycin Hydrochloride 150 mg


Ph Eur

60

Pharmacia & UpJohn


BELGIUM

Clindamycin Palmitate
Hydrochloride USP

75 mg/5ml

60

Kela N.V
BELGIUM

Clindamycin Palmitate
Hydrochloride USP

75 mg/5ml

60

Kela N.V
BELGIUM

Clindamycin Palmitate
Hydrochloride USP

75 mg/5ml

60

Kela N.V
BELGIUM

Dalacin C,Syrup

Dalacin,Capsules

Dalacin C,Syrup

Dalacin C,Syrup

Dalacin C,Syrup

Pharmacia Ltd. - ITALY

Page 403 of 584

Human Medicinal Products


S/No:

Registration Number

2,549 TZ10H108

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,550 TAN 06,095 C01E PHA

2,551 TAN 06,427 A02A PHA

Registrant
2,552 TAN 00,4491 J05A PHA

2,553 TAN 00,830 N05A PHG

2,554 TAN 07,379 J02A PHA

Manufacturer

Unimol,Suspension

Paracetamol BP

Registrant

Shelf life
month

120 mg/5ml

36

Pharmaceutical
Manufacturing Co.(K) Ltd.
KENYA

Pharmatec Pakistan (PVT) Ltd. - PAKISTAN


Lotide,Tablet
Pharmatec Pakistan (PVT)
Ltd.
PAKISTAN

Lisinopril USP

10 mg

24

Aluminium Hydroxide IH

216 mg

24

Acyclovir Ph Eur

5 %w/w

24

Pharmathen Ltd
GREECE

Bromazepam Ph Eur

1.5 mg

36

Pharmathen Ltd
GREECE

Fluconazole IH

150 mg

36

Pharmathen SA
GREECE

Actin,Tablet
Pharmatec Pakistan (PVT)
Ltd.
PAKISTAN

Pharmathen SA - GREECE
Amitrox,Cream

Pascalium,Tablet

Stabilanol,Capsules

Page 404 of 584

Human Medicinal Products


S/No:

Registration Number

2,555 TAN 07,380 J01K PHA

2,556 TAN 00,828 D01B PHG

2,557 TAN 00,830 N05A PHG

2,558 TAN 00,830 N05A PHG

Registrant
2,559 C444

2,560 C622

Product Name
Pack and Pack size

Ingredient(s) and Strength

Lanomycin,Injectable
Solution

Shelf life
month

Manufacturer

Amikacin Sulphate Ph Eur

125 mg/2ml

24

Pharmathen SA
GREECE

Fluconazole IH

100 mg

36

Pharmathen SA
GREECE

Bromazepam Ph Eur

1.5 mg

36

Pharmathen Ltd
GREECE

Bromazepam Ph Eur

1.5 mg

36

Pharmathen Ltd
GREECE

Niacinamide BP
Thiamine Hydrochloride BP
Riboflavin BP
Pyridoxine Hydrochloride
Ascorbic Acid BP

20 mg/10ml
2 mg/10ml
1 mg/10ml
0.5 mg/10ml

24

Caffeine BP
Chlorpheniramine Maleate
BP
Paracetamol BP
Phenylephrine
Hydrochloride BP

30 mg
4 mg

36

Stabilanol,Capsules

Pascalium,Tablet

Pascalium,Tablet

Pharmed Ltd. - TANZANIA


Phamavit,Syrup
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Cold off,Capsules

Page 405 of 584

500 mg
5 mg

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

2,561 C444

2,562 TAN 00,2615 R05A PHD

Registrant
2,563 TAN 00,4568 N01A NIC

2,564 TAN 00,4567 A10B NIC

2,565 TAN 00,4569 C04A NIC

2,566 TAN 00,4373 R06A NIC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Phamavit,Syrup

Niacinamide BP
Thiamine Hydrochloride BP
Riboflavin BP
Pyridoxine Hydrochloride
Ascorbic Acid BP

20 mg/10ml
2 mg/10ml
1 mg/10ml
0.5 mg/10ml

24

Caffeine BP
Chlorpheniramine Maleate
BP
Paracetamol BP
Phenylephrine
Hydrochloride BP

30 mg
4 mg

36

Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

Cold off,Capsules
Aurochem Pharmaceuticals
(India) Pvt. Ltd.
INDIA

500 mg
5 mg

PIRAMAL HEALTHCARE LIMITED - INDIA


Halothane,Liquid

Halothane BP

250 ml

60

Nicholas Piramla India Ltd


INDIA

Pioglitazone Hydrocloride
equivalent Pioglitazone IH

15 mg

24

Nicholas Piramal India Ltd.


INDIA

Isosorbide Dinitrate BP

10 mg

48

Nicholas Piramal India Ltd.


INDIA

Cetrizine Hydrochloride BP 10 mg

24

Nicholas Piramal India Ltd.


INDIA

Pionic,Tablet

Nichotrate,Tablet

Alirix,Tablet

Page 406 of 584

Human Medicinal Products


S/No:

Registration Number

2,567 TAN 00,4438 S01B ALL

Product Name
Pack and Pack size

Ingredient(s) and Strength

FML Liquifilm,Ophthalmic
Solution

2,569 TAN 05,041 H03B NIC

2,570 TAN 07,205 N01A NIC

2,571 TAN 07,524 N01A NIC

2,572 TAN 07,523 N01A NIC

Registrant

Manufacturer

1 mg/ml

36

Piramal Health Care


INDIA

Gelatin IH
Potassium Chloride Ph Eur
Sodium Chloride Ph Eur
Calcium Chloride Dihydrate
Ph Eur

20 g/500ml
0.191 g/500ml
4.33 g/500ml
0.227 g/500ml

36

Nicholas Piramal India Ltd.


INDIA

Carbimazole BP

5 mg

24

Nicholas Piramal India Ltd.


INDIA

Thiapental Sodium BP

500 mg

36

Nicholas Piramal India Ltd.


INDIA

Halothane BP

100 %

60

Nicholas Piramal India Ltd


INDIA

Isoflurane BP

100 %v/v

60

Nicholas Piramal India Ltd


INDIA

Fluorometholone USP

2,568 TAN 00,4489 B05B NIC

Shelf life
month

Sterile Polygeline,Solution

Carbizole,Tablet

Thiopental,Powder for
Injection

Halothane,Solution

Isoflurane,Solution

Platinum Pharmaceuticals (PVT) Ltd. - PAKISTAN

Page 407 of 584

Human Medicinal Products


S/No:

Registration Number

2,573 TAN 06,203 J01F PLA

2,574 TAN 06,204 R03A PLA

Registrant
2,575 TZ10H111

2,576 TZ10H112

Registrant
2,577 TAN 08,153 N02B PLE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Plazo,Tablet

Azithromycin Dihydrate eq
to Azithromycin USP

250 mg

24

Terbutaline Sulphate USP

2.5 mg

36

Platinum Pharmaceuticals
(PVT) Ltd.
PAKISTAN

Brethin,Tablet
Platinum Pharmaceuticals
(PVT) Ltd.
PAKISTAN

Plethico Pharmaceuricals Ltd. - INDIA


Arvaz 10,Tablets

Atorvastatin IH

10 mg

36

Plethico Pharmaceutical Ltd


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

36

Plethico Pharmaceutical Ltd


INDIA

Tramadol Hydrochloride IH 50 mg/ml

36

Plethico Pharmaceutical Ltd


INDIA

Fluconazole USP

36

Plethico Pharmaceutical Ltd


INDIA

Arvaz 20,Tablets

Plethico Pharmaceutical Ltd - INDIA


Plazadol,Injectable Solution

2,578 TAN 10, 041 J041 J02A PLEOdaft,Capsules

Page 408 of 584

150 mg

Human Medicinal Products


S/No:

Registration Number

2,579 TAN 10,040 N02B PLE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Ceftrox,Dry powder for


Injection

Ceftriaxone Sodium USP

Registrant
2,581 TZ09H002

36

Plethico Pharmaceutical Ltd


INDIA

1000 mg

24

Plethico Pharmaceutical Ltd


INDIA

150mg
300mg

24

150 mg/ml

36

PMS(DMC) - TANZANIA
Zidolam,Tablet

Lamivudine IH
Zidovudine IH

Registrant
2,582 TZ11H174

Population Services - TANZANIA


Familia DMPA Injection
Kit,Suspension

Medroxyprogesterone
Acetate (None)

Registrant
2,583 TAN 09,290 V03A PRI

Bodene (PTY) Ltd trading as


Intramed,
SOUTH AFRICA

Prisma Pharmaceuticals Ltd - UNITED KINGDOM


Flora Norm,Powder

Saccharomyces Boulardii IH 250 mg

Registrant

Manufacturer

Plazadol,Capsules

Tramadol Hydrochloride BP 50 mg

2,580 TZ11H181

Shelf life
month

Procter & Gamble(EA) Ltd. - KENYA

Page 409 of 584

18

Bharat Biotech
International Limited
INDIA

Human Medicinal Products


S/No:

Registration Number

2,584 TAN 05,680 R05B PRO

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,585 TAN 00,2440 P02X SIM

2,587 TAN 07,552 J01D RAN

2,588 TAN 09,199 J01F RAN

2,589 TAN 07,395 J05A RAN

24

Makson Health Care (P) Ltd


INDIA

Mebendazole,Tablet
Quantum Remedies Private
Ltd
INDIA

100 mg

36

200 mg

36

Cefpodoxime Proxetil
equivalent to Cefpodoxime
IH

200 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Clarithromycin IH

500 mg

24

Ranbaxy Laboratories
INDIA

20 mg
5 mg
35 mg

24

Ranbaxy Laboratories Ltd


INDIA

Metronidazole,Tablet

Metronidazole BP

Registrant

0.34 %w/w
0.24 %w/w

Quantum Remedies Private Ltd - INDIA


Mebendazole USP

2,586 TAN 00,2442 P01A SIM

Manufacturer

Vicks Kingo,Lozenges

Levomenthol Ph Eur
Eucalyptus Ph Eur

Registrant

Shelf life
month

Quantum Remedies Private


Ltd
INDIA

Ranbaxy Laboratories Ltd - INDIA


Cepodem,Tablet

Klabax,Tablet

Triviro LNS Kid,Tablet

Lamivudine USP
Stavudine USP
Nevirapine Hemihydrate
equivalent to Nevirapine
USP

Page 410 of 584

Human Medicinal Products


S/No:

Registration Number

2,590 TAN 07,394 J02A RAN

2,591 TAN 07,393 J01F RAN

2,592 TAN 07,392 J02A RAN

2,593 TAN 07,385 A10B RAN

2,594 TAN 07,386 M01A RAN

2,595 TAN 07,391 D01A RAN

2,596 TAN 07,553 J01D RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Flucoric,Capsules

Fluconazole IH

150 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Clarithromycin BP

250 mg

24

Ranbaxy Laboratories
INDIA

Fluconazole IH

200 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Gliclazide Ph Eur

30 mg

24

Ranbaxy Laboratories Ltd


INDIA

Ibuprofen BP
Paracetamol BP

400 mg
325 mg

36

Ranbaxy Laboratories
INDIA

Clotrimazole USP

100 mg

24

Ranbaxy Laboratories
INDIA

Cefpodoxime Proxetil
equivalent to Cefpodoxime
IH

100 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Klabax,Tablet

Flucoric,Capsules

Remicron MR,Tablet

Brustan,Tablet

Gynostatum 100,Tablet

Cepodem,Tablet

Page 411 of 584

Human Medicinal Products


S/No:

Registration Number

2,597 TAN 07,551 J03B RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,599 TAN 09,199 J01F RAN

2,600 TZ11H018

Registrant
2,601 TAN 00,196 A11A RAN

Manufacturer

Silverex,Cream
24

Ranbaxy Laboratories
INDIA

Metformin Hydrochloride Ph 1000 mg


Eur

24

Ranbaxy Laboratories
INDIA

Clarithromycin IH

500 mg

24

Ranbaxy Laboratories
INDIA

Sodium Alendronate
Anhydrous equivalent to
Aledronic BP

70 mg

24

Ranbaxy Laboratories Ltd


INDIA

Chlorhexidine Gluconate BP 0.2 %w/w


1 %w/w
Silver Sulphadiazine USP

2,598 TAN 08,154 A10B RAN

Shelf life
month

Ranophage OD,Tablet

Klabax,Tablet

Alendronate,Tablet

Ranbaxy Laboratories Ltd. - INDIA


Revital Ginseng Plus,Capsules

Page 412 of 584

Human Medicinal Products


S/No:

Registration Number

2,602 TAN 00,441 A02A RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Calcium Phospate Dibasic


BP Eq. to Calcium IH
Ascorbic Acid BP
Calcium D-Pantothenate
USP
Cholecalciferol IH
Choline Bitartarate IH
Copper Sulfate
Pentahydrate IH
Cyanocobalamine BP
DL-Methionine BP
Folic Acid BP
Ginseng root extract IH
Inositol IH
Iron (Ferrous Fumarate)
USP
Magnesium Sulphate BP
Manganese Sulphate USP
Niacinamide USP
Phosphorous IH
Potasium Iodide BP
Potassium Sulphate IH
Pyridoxine Hydrochloride
Ascorbic Acid BP
Riboflavine USP
Thiamine Mononitrate USP
Tocopheryl Acetate
Nicotinamide
Dexapanthenol IH
Vitamin A USP
Zinc USP

75 mg

Aluminium Hydroxide BP

300 mg

Shelf life
month

Manufacturer

24

Ranbaxy Laboratories Ltd.


INDIA

36

Ranbaxy Laboratories Ltd.


INDIA

40 mg
5 mg
500 IU
50 mg
0.5 mg
2 mcg
50 mg
0.5 mg
42.5 mg
50 mg
15 mg
3 mg
0.5 mg
5 mg
58 mg
0.1 mg
2 mg
1 mg
3 mg
5 mg
10 mg

5000 IU
0.5 mg

Gestid,Tablet

Page 413 of 584

Human Medicinal Products


S/No:

Registration Number

2,603 TAN 00,4623 J01K RAN

2,604 TAN 00,4160 C04A RAN

2,605 TAN 00,4377 J05A RAN

2,606 TAN 00,4379 J05A RAN

2,607 TAN 00,4493 J05A RAN

2,608 TAN 00,4494 J05A RAN

2,609 TAN 00,4516 J05A RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Cifran CT,Tablet
600 mg
Tinidazole BP
500 mg
Ciprofloxacin USP
Ciprofloxacin Hydrochloride 500 mg
USP

24

Ranbaxy Laboratories Ltd.


INDIA

Amlodipine Besylate BP

5 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Stavudine IH

30 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Zidovudine USP

300 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Lamivudine IH
Stavudine IH

150 mg
40 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Lamivudine IH
Stavudine IH

150 mg
30 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Lamivudine IH
Nevirapine IH
Stavudine IH

150 mg
200 mg
40 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Amlovas,Tablet

Avostav,Capsules

Aviro Z,Tablet

Coviro LS,Tablet

Coviro LS,Tablet

Triviro LNS,Tablet

Page 414 of 584

Human Medicinal Products


S/No:

Registration Number

2,610 TAN 00,4515 J05A RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

150 mg
200 mg
30 mg

24

Ranbaxy Laboratories Ltd.


INDIA

125 mg/5ml

36

Ranbaxy Laboratories Ltd.


INDIA

1g

36

Ranbaxy Laboratories Ltd.


INDIA

Ceftriaxone Sodium USP

250 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Cefaclor IH

125 mg/5ml

24

Ranbaxy Laboratories Ltd.


INDIA

125 mg
Clavulanic Acid Ph Eur
Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin Ph
Eur

24

Ranbaxy Laboratories Ltd.


INDIA

Clavulanic Acid USP


Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

24

Ranbaxy Laboratories Ltd.


INDIA

Sporidex,Suspension

Cephalexin Monohydrate
equivalent to Cephalexin
Anhydrous IH
2,612 TAN 00,579 J01D RAN

Oframax,Powder for Injection

Ceftriaxone Sodium
equivalent to Ceftriaxone
USP
2,613 TAN 00,173 J01D RAN

2,614 TAN 00,184 J01D RAN

2,615 TAN 00,194 J01H RAN

2,616 TAN 00,195 J01H RAN

Manufacturer

Triviro LNS,Tablet

Lamivudine IH
Nevirapine IH
Stavudine IH
2,611 TAN 00,171 J01D RAN

Shelf life
month

Oframax,Powder for Injection

Vercef,Suspension

Enhancin,Tablet

Enhancin,Tablet

Page 415 of 584

125 mg
500 mg

Human Medicinal Products


S/No:

Registration Number

2,617 TAN 05,051 J01D RAN

2,618 TAN 05,810 B04A RAN

2,619 TAN 05,808 B04A RAN

2,620 TAN 06,324 J01F RAN

2,621 TAN 06,325 J01F RAN

2,622 TAN 06,329 J01F RAN

2,623 TAN 06,328 J01D RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Kefloxin,Capsules

Cefadroxil Anhydrous
equivalent to Cefadroxil
USP

500 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

10 mg

24

Ranbaxy Laboratories Ltd


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

24

Ranbaxy Laboratories Ltd


INDIA

Clarithromycin IH

125 mg/5ml

24

Ranbaxy Laboratories Ltd.


INDIA

Clarithromycin IH

250 mg/5ml

24

Ranbaxy Laboratories Ltd.


INDIA

Clarithromycin USP

500 mg

24

Ranbaxy Laboratories Ltd.


INDIA

125 mg/5ml

24

Ranbaxy Laboratories Ltd.


INDIA

Storvas,Tablet

Storvas,Tablet

Klabax,Suspension

Klabax,Suspension

Klabax,Tablet

Ceroxim,Suspension

Cefuroxime Axetil
equivalent to Cefuroxime
USP

Page 416 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

2,624 TAN 06,327 J01D RAN

Ceroxim,Powder for
Suspension

2,625 TAN 06,330 J01K RAN

2,626 TAN 06,323 J01K RAN

2,627 TAN 06,432 N05A RAN

2,628 TAN 06,434 N05A RAN

2,629 TAN 06,438 C01K RAN

2,630 TAN 06,437 C01K RAN

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Cefuroxime Axetil
equivalent to Cefuroxime
USP

250 mg/5ml

24

Ranbaxy Laboratories Ltd.


INDIA

Ciprofloxacin Ph Eur

500 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Ciprofloxacin Ph Eur

1000 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Sertraline Hydrochloride
equivalent to Sertraline IH

100 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Sertraline Hydrochloride
equivalent to Sertraline IH

50 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Ramipril BP

2.5 mg

24
Month
s

Ramipril BP

5 mg

24
Month
s

Cifran OD,Tablet

Cifran OD,Tablet

Serlift,Tablet

Serlift,Tablet

Corpril,Capsules
Ranbaxy Laboratories Ltd.
INDIA

Corpril,Capsules

Page 417 of 584

Ranbaxy Laboratories Ltd.


INDIA

Human Medicinal Products


S/No:

Registration Number

2,631 TAN 06,436 C01K RAN

2,632 TAN 06,435 J05A RAN

2,633 TAN 06,430 J05A RAN

2,634 TAN 06,429 J05A RAN

2,635 TAN 07,096 J05A RAN

2,636 TAN 07,095 J05A RAN

2,637 TAN 07,098 J05A RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Corpril,Capsules
Ranbaxy Laboratories Ltd.
INDIA

Ramipril BP

10 mg

24
Month
s

Lamivudine USP
Nevirapine USP
Stavudine USP

150 mg
200 mg
30 mg

24
Month
s

Stavudine USP

30 mg

24

Ranbaxy Laboratories Ltd


INDIA

Efavirenz IH

200 mg

24

Ranbaxy Laboratories Ltd


INDIA

Lamivudine USP

150 mg

24

Ranbaxy Laboratories Ltd


INDIA

Zidovudine USP

300 mg

24

Ranbaxy Laboratories Ltd


INDIA

Lamivudine USP
Stavudine USP

150 mg
30 mg

24

Ranbaxy Laboratories Ltd


INDIA

Triviro LNS,Tablet
Ranbaxy Laboratories Ltd
INDIA

Avostav,Tablet

Aviranz,Tablet

Avolam,Tablet

Aviro-Z,Tablet

Coviro LS,Tablet

Page 418 of 584

Human Medicinal Products


S/No:

Registration Number

2,638 TAN 07,216 J05A RAN

2,639 TAN 07,215 J05A RAN

2,640 TAN 00,177 B03A RAN

2,641 TAN 00,188 J05A RAN

2,642 TAN 00,190 N02B RAN

2,643 TAN 00,337 J01D RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Avocomb,Tablet

Lamivudine USP
Zidovudine USP

150 mg
300 mg

24

Ranbaxy Laboratories Ltd


INDIA

Nevirapine IH

200 mg

24

Ranbaxy Laboratories Ltd


INDIA

Ferrous fumerate equivalent


to Iron BP
Folic Acid BP
Cyanocobalamin USP
Ascorbic Acid USP
Zinc Sulphate BP

100 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Acyclovir BP

400 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Ibuprofen BP
Paracetamol BP

400 mg
325 mg

36

Ranbaxy Laboratories Ltd.


INDIA

Cefaclor IH

375 mg

36

Ranbaxy Laboratories Ltd.


INDIA

Nevipan,Tablet

Ranferon,Capsules

0.75 mg
5 mcg
75 mg
5 mg

Lovir,Tablet

Brustan,Tablet

Vercef MR,Tablet

Page 419 of 584

Human Medicinal Products


S/No:

Registration Number

2,644 TAN 07,387 A11A RAN

2,645 TAN 07,388 A02B RAN

2,646 TAN 07,389 N05A RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Revigin,Capsules
24

Ranbaxy Laboratories Ltd


INDIA

40 mg

24

Ranbaxy Laboratories Ltd.


INDIA

40 mg

36

Ranbaxy Laboratories Ltd.


INDIA

Magnesium BP
Niacinamide BP
Folic Acid BP
Vitamin B2 BP
Vitamin B6 BP
Vitamin C BP
Vitamin D3 IH
Ginseng IH
Iodide (As Potassium Iodide)
IH
Potassium (as Potassium
Sulfate) IH
Copper IH
Iron USP
Manganese USP
Zinc USP
Calcium USP
Phosphorous USP
Vitamin A USP
Vitamin E USP
Calcium D Panthothenate
USP
Vitamin B1 USP

3 mg
20 mg
0.5 mg
3 mg
1 mg
40 mg
500 IU
42.5 mg
0.1 mg

Pantoprazole IH

Citalopram Hydrobromide
(eq to Citalopram) IH

2 mg
0.5 mg
15 mg
0.5 mg
0.5 mg
75 mg
58 mg
5000 IU
10 mg
5 mg
5 mg

Pansec DR,Tablet

Celica,Tablet

Page 420 of 584

Human Medicinal Products


S/No:

Registration Number

2,647 TAN 07,381 N05A RAN

2,648 TAN 07,382 D01B RAN

2,649 TAN 07,390 J05A RAN

2,650 TAN 07,384 J05A RAN

2,651 TAN 07,535 M02A RAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Celica,Tablet

Citalopram Hydrobromide
(eq to Citalopram) IH

20 mg

36

Ranbaxy Laboratories Ltd.


INDIA

Terbinafine Hydrochloride
IH

250 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Abacavir Sulphate IH

300 mg

24

Ranbaxy Laboratories Ltd


INDIA

Efavirenz IH
Lamivudine USP
Zidovudine USP

600 mg
150 mg
300 mg

24

Ranbaxy Laboratories Ltd


INDIA

Diclofenac
Diethylammonium
equivalent to Diclofenac
Sodium BP
Methyl Salicylate

1 %w/w

24

Ranbaxy Laboratories
INDIA

Sebifin,Tablet

Abac,Tablet

Avocomb-E,Tablet

Volini,Gel

Methyl Salicylate BP
Paracetamol BP
Linseed Oil BP

Page 421 of 584

10 %w/w

5 %w/w
3 %w/w

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

2,652 TAN 07,542 S01C RAN

Gentalene C,Cream

Ingredient(s) and Strength

2,654 TAN 07,540 J05A RAN

2,655 TAN 00,1891 J01C RAN

2,656 TAN 00,4158 J01C RAN

2,657 TAN 00,4161 J01D RAN

Manufacturer

24

Ranbaxy Laboratories
INDIA

Amoxicillin Trihydrate
1000 mg
equivalent to Amoxicillin Ph
Eur
200 mg
Clavulanic Acid USP

24

Ranbaxy Laboratories Ltd.


INDIA

Lamivudine USP
Nevirapine USP
Zidovudine USP

24

Ranbaxy Laboratories Ltd


INDIA

Amoxicillin Trihydrate
250 mg/5ml
equivalent to Amoxicillin Ph
Eur
Potassium Clavulanate eq to 62.5 mg/5ml
Clavulanic Acid IH

18

Ranbaxy Laboratories Ltd.


INDIA

Clavulanic Acid IH
Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

125 mg
875 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Cefuroxime Axetil
equivalent to Cefuroxime
USP

250 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Clotrimazole USP
Betamethasone
Dipropionate USP
Gentamicin Sulphate
equivalent to Gentamicin
USP
2,653 TAN 00,2187 J01C RAN

Shelf life
month

1 %w/w
0.05 %w/w
0.1 %w/w

Enhancin,Powder for Injection

Avocomb N,Tablet
150 mg
200 mg
300 mg

Enhancin,Suspension

Enhancin,Tablet

Ceroxim,Tablet

Page 422 of 584

Human Medicinal Products


S/No:

Registration Number

2,658 TAN 00,4323 J01D RAN

2,659 TAN 09,198 J05A RAN

2,660 TAN 09,291 J05A RAN

2,661 TAN 05,808 B04A RAN

2,662 TAN 05,808 B04A RAN

Registrant
2,663 TZ10H007

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Ceroxim,Tablet

Cefuroxime Axetil
equivalent to Cefuroxime
USP

500 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Indinavir Sulphate IH

400 mg

24

Ranbaxy Laboratories Ltd


INDIA

Efavirenz IH

200 mg

24

Ranbaxy Laboratories Ltd.


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

24

Ranbaxy Laboratories Ltd


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

24

Ranbaxy Laboratories Ltd


INDIA

Avirodin,Capsules

Aviranz,Capsules

Storvas,Tablet

Storvas,Tablet

Reckitt Benckiser south africa - SOUTH AFRICA


Strepsils Honey and
Lemon,Lozenges

36

Page 423 of 584

Reckitt Benckiser
Healthcare Manufacturing
(Thailand) Ltd.
THAILAND

Human Medicinal Products


S/No:

Registration Number

2,664 TZ10H128

2,665 TZ10H129

Product Name
Pack and Pack size
Strepsils Vitamin
C-100,Lozenges

Ingredient(s) and Strength

Amylmetacresol BP
Dichlorobenzyl Alcohol IH
Vitamin C IH

2,666 TAN 05,200 A16A REG

0.6 mg
1.2 mg
100 mg

36

0.6 mg
1.2 mg

36

2,668 TAN 05,531 H02A REG

2,669 TAN 05,528 D04A REG

Reckitt Benckiser
Healthcare Manufacturing
(Thailand) Ltd.
THAILAND

Reckitt Benckiser
Healthcare Manufacturing
(Thailand) Ltd.
THAILAND

Regal Pharmaceuticals Ltd - KENYA


Intaplex,Tablet
1 mg
Riboflavine BP
Thiamine Hydrochloride BP 1 mg
15 mg
Nicotinamide BP

2,667 TAN 05,529 J01A REG

Manufacturer

Strepsils Cool,Lozenges

Amylmetacresol BP
Dichlorobenzyl Alcohol IH

Registrant

Shelf life
month

24

Regal Pharmaceuticals Ltd


KENYA

Intacycline,Ointment

Tetracycline Hydrochloride
BP

3 %w/w

24

Regal Pharmaceuticals Ltd


KENYA

Prednisolone BP

5 mg

48

Regal Pharmaceuticals Ltd


KENYA

48

Regal Pharmaceuticals Ltd


KENYA

Predilone,Tablet

Intamine,Tablet

Promethazine Hydrochloride 25 mg
BP

Page 424 of 584

Human Medicinal Products


S/No:

Registration Number

2,670 TAN 05,527 J01F REG

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,672 TAN 00,1177 R05E REG

2,673 TAN 06,233 A02C REG

2,674 TAN 06,205 D01A REG

2,675 TAN 00,1174 P01A REG

Manufacturer

Erythyl,Dry Syrup
125 mg/5ml

30

Regal Pharmaceuticals Ltd


KENYA

Chloramphenicol Palmitate
BP

125 mg/5ml

36

Regal Pharmaceuticals Ltd


KENYA

Thiamine Hydrochloride BP
Ascorbic Acid BP
Vitamin A BP
Nicotinamide BP
Riboflavine Phosphate BP
Cyanocobalamin BP

1.5 mg
40 mg
1000 IU
10 mg
1.5 mg
2.5 mcg

24

Regal Pharmaceuticals Ltd


KENYA

Albendazole USP

200 mg

48

Regal Pharmaceuticals Ltd


KENYA

Miconazole Nitrate BP

2 %w/w

24

Regal Pharmaceuticals Ltd


KENYA

Metronidazole BP

200 mg

48

Regal Pharmaceuticals Ltd


KENYA

Erythromycin
EthylSuccinate BP

2,671 TAN 05,530 J01B REG

Shelf life
month

Chlorocide,Suspension

Rinavit,Syrup

Albasol,Tablet

Dermidex,Cream

Megyl,Tablet

Page 425 of 584

Human Medicinal Products


S/No:

Registration Number

2,676 TAN 00,1175 R01A REG

2,677 TAN 00,1480 D07A REG

2,678 TAN 00,1481 D07A REG

2,679 TAN 00,1176 D07 REG

2,680 TAN 00,1178 J01B REG

2,681 TAN 00,1179 N02B REG

2,682 TAN 00,1180 N02B REG

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Isoryn Paediatric,Solution

Ephedrine Hydrochloride
BP

5 mg/ml

36

Regal Pharmaceuticals Ltd


KENYA

Hydrocortisone BP

10 mg

36

Regal Pharmaceuticals Ltd


KENYA

Betamethasone BP

0.1 %w/w

36

Regal Pharmaceuticals Ltd


KENYA

Betamethasone Valerate BP 0.1 %w/w

36

Regal Pharmaceuticals Ltd


KENYA

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

48

Regal Pharmaceuticals Ltd


KENYA

Paracetamol BP

500 mg

48

Regal Pharmaceuticals Ltd


KENYA

Paracetamol BP

120 mg/5ml

36

Regal Pharmaceuticals Ltd


KENYA

Lucin,Ointment

Mediven,Cream

Mediven,Ointment

Unitrim,Tablet

Cetamol,Tablet

Cetamol,Syrup

Page 426 of 584

Human Medicinal Products


S/No:

Registration Number

2,683 TAN 00,1181 R05A REG

Product Name
Pack and Pack size

Ingredient(s) and Strength

30 mg
4 mg

2,688 A653/2006/1

36

Regal Pharmaceuticals Ltd


KENYA

36

Regal Pharmaceuticals Ltd


KENYA

48

Regal Pharmaceuticals Ltd


KENYA

24

Regal Pharmaceuticals Ltd


KENYA

48

Regal Pharmaceuticals Ltd


KENYA

Isoryn Adults,Solution
10 mg/ml

Amobin,Tablet

Amodiaquine Hydrochloride 200 mg


BP

2,687 TAN 00,1188 A13A REG

Regal Pharmaceuticals Ltd


KENYA

Megyl,Suspension

Ephedrine Hydrochloride
BP

2,686 TAN 00,1186 P01B REG

36

400 mg
30 mg

Metronidazole Benzoate BP 200 mg/5ml

2,685 TAN 00,1183 R01A REG

Manufacturer

Coldcap,Capsules

Caffeine Anhydrous BP
Chlorpheniramine Maleate
BP
Paracetamol BP
Pseudoephedrine
Hydrochloride BP
2,684 TAN 00,1182 P01A REG

Shelf life
month

Ferro B Complex,Syrup

Thiamine Hydrochloride BP
Ferric Ammonium Citrate
BP
Nicotinamide BP
Cyanocobalamin BP
Riboflavin Sodium
Phosphate BP

5 mg
200 mg

Hydrocortisone BP

1%

5 mg
2.5 mg
0.5 mg

Lucin,Cream

Page 427 of 584

Human Medicinal Products


S/No:

Registration Number

2,689 TAN 00,1189 D07A REG

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,691 TAN 00,1191 R03A REG

2,692 TAN 00,1488 M01A REG

2,693 TAN 00,1489 D01A REG

2,694 TAN 00,1490 M01A REG

Manufacturer

Lucin,Cream
1 %w/v

36

Regal Pharmaceuticals Ltd


KENYA

Diphenhydramine
Hydrochloride BP
Sodium Citrate BP
Ammonium Chloride BP

14 mg/5ml

36

Regal Pharmaceuticals Ltd


KENYA

Dextromethorphan
Hydrobromide BP
Diphenhydramine
Hydrochloride BP
Menthol BP
Sodium Citrate BP

6.5 mg/ml

36

Regal Pharmaceuticals Ltd


KENYA

Ibuprofen BP

200 mg

48

Regal Pharmaceuticals Ltd


KENYA

Clotrimazole BP

1 %w/w

36

Regal Pharmaceuticals Ltd


KENYA

Ibuprofen BP

100 mg/5ml

36

Regal Pharmaceuticals Ltd


KENYA

Hydrocortisone BP

2,690 TAN 00,1190 R03A REG

Shelf life
month

Delased Chesty,Syrup

1.1 mg/5ml
135 mg/5ml

Delased,Syrup

14 mg/ml
2 mg/5ml
57 mg/ml

Ibumex,Tablet

Unisten,Cream

Ibumex,Suspension

Page 428 of 584

Human Medicinal Products


S/No:

Registration Number

2,695 TAN 00,1482 R05E REG

2,696 TAN 00,1673 J01H REG

2,697 TAN 00,1485 P01B REG

2,698 TAN 00,1674 J01H REG

2,699 TAN 00,1491 J01H REG

2,700 TAN 00,1492 A02A REG

2,701 TAN 00,1675 A02A REG

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Delased Paediatric,Syrup
36

Regal Pharmaceuticals Ltd


KENYA

250 mg

36

Regal Pharmaceuticals Ltd


KENYA

Pyrimethamine BP
Sulfadoxine BP

25 mg
500 mg

48

Regal Pharmaceuticals Ltd


KENYA

Ampicillin Trihydrate
equivalent to Ampicillin BP

125 mg/5ml

30

Regal Pharmaceuticals Ltd


KENYA

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

30

Regal Pharmaceuticals Ltd


KENYA

Diphenhydramine
Hydrochloride BP
Menthol BP
Sodium Citrate BP

7 mg/5ml

Ampicillin Trihydrate
equivalent to Ampicillin BP

0.55 mg/5ml
28.5 mg/5ml

Uniamp,Capsules

Intadoxine,Tablet

Uniamp,Syrup

Unixil,Syrup

Magnomint,Suspension

Aluminium Hydroxide BP
Magnesium Trisilicate BP

250 mg/5ml
500 mg/5ml

36

Regal Pharmaceuticals Ltd


KENYA

Aluminium Hydroxide BP
Magnesium Trisilicate BP

125 mg
250 mg

48

Regal Pharmaceuticals Ltd


KENYA

Magnomint,Tablet

Page 429 of 584

Human Medicinal Products


S/No:

Registration Number

2,702 TAN 00,1493 P02X REG

2,703 TAN 00,1494 J01C REG

2,704 TAN 00,1496 M02A REG

2,705 TAN 00,1497 D04A REG

2,706 TAN 00,1498 D04A REG

2,707 TAN 00,1499 D01A REG

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Rohisol,Tablet

Levamisole Hydrochloride
BP

40 mg

48

Regal Pharmaceuticals Ltd


KENYA

Ampicillin Trihydrate BP
Cloxacillin Sodium BP

125 mg/5ml
125 mg/5ml

24

Regal Pharmaceuticals Ltd


KENYA

Methyl Salicylate

5 %w/w

36

Regal Pharmaceuticals Ltd


KENYA

Methyl Salicylate BP
Methyl Nicotinate BP
Capsicum Oleoresin BP

1 %w/w
0.1 %w/w

Promethazine Hydrochloride 5 mg/5ml


BP

36

Regal Pharmaceuticals Ltd


KENYA

Mepyramine Maleate BP

2 %w/w

36

Regal Pharmaceuticals Ltd


KENYA

6 %w/w
3 %w/w

36

Regal Pharmaceuticals Ltd


KENYA

Medicloamp,Syrup

Rubem,Cream

Intamine P,Solution

Intamine M,Cream

Whitfields,Ointment

Benzoic Acid BP
Salicylic Acid BP

Page 430 of 584

Human Medicinal Products


S/No:

Registration Number

2,708 TAN 07,103 A02C REG

2,709 TAN 07,102 A03B REG

2,710 TAN 07,101 J03C REG

2,711 TAN 07,100 REG

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,713 TAN 07,104 A03B REG

2,714 TAN 07,217 A07D REG

Manufacturer

Albasol,Suspension
Regal Pharmaceuticals Ltd
KENYA

Albendazole USP

200 mg/5ml

24
Month
s

Hyoscine Butylbromide BP

10 mg

48

Regal Pharmaceuticals Ltd


KENYA

Nalidixic Acid BP

500 mg

48

Regal Pharmaceuticals Ltd


KENYA

100 mg

36

Regal Pharmaceuticals Ltd


KENYA

Dextromethorphan
Hydrobromide IP

7.5 mg

36

Regal Pharmaceuticals Ltd


KENYA

Hyoscine Butylbromide BP

5 mg/ml

36

Regal Pharmaceuticals Ltd


KENYA

Loperamide Hydrochloride
BP

2 mg

36

Regal Pharmaceuticals Ltd


KENYA

Bispanol,Tablet

Uriseptic,Tablet

Delased chesty cough,Syrup

Guaiphenesin BP

2,712 TAN 07,099 R02A REG

Shelf life
month

Delased Dry Coughs,Syrup

Bispanol,Elixir

Dialin,Capsules

Page 431 of 584

Human Medicinal Products


S/No:

Registration Number

2,715 TAN 07,396 P01B REG

2,716 TAN 07,397 D07X REG

2,717 TAN 07,398 J01C REG

Product Name
Pack and Pack size

Ingredient(s) and Strength

Quinidine Hydrochloride BP 100 mg/5ml

36

Regal Pharmaceuticals Ltd


KENYA

Clotrimazole BP
Hydrocortisone BP

36

Regal Pharmaceuticals Ltd


KENYA

24

Regal Pharmaceuticals Ltd


KENYA

48

Regal Pharmaceuticals Ltd


KENYA

36

Regal Pharmaceuticals Ltd


KENYA

Unisten-H,Cream
1 %w/w
1 %w/w

Mediclox,Syrup

Mebendazole,Tablet

Mebendazole USP

2,719 TAN 09,061 V03A REG

100 mg

Sonatec Mouthwash,Solution

Cetylpyridinium Chloride BP 0.05 %w/v

Registrant
2,720 TAN 09,062 M01A REL

Reliance Pharmaceuticals - TANZANIA


Relifenac,Injection

Diclofenac Sodium BP

Registrant

Manufacturer

Curaquin,Syrup

Cloxacillin Sodium
125 mg/5ml
equivalent to Cloxacillin BP

2,718 TAN 00,1185 P02X REG

Shelf life
month

Remedica Ltd. - CYPRUS

Page 432 of 584

25 mg/ml

36

Umedica Laboratories Pvt


Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

2,721 TAN 00,1676 C03D REM

2,722 TAN 00,1678 C06A REM

2,723 TAN 00,1679 C06A REM

2,724 TAN 00,1681 C01E REM

2,725 TAN 00,1683 L02B REM

2,726 TAN 00,1892 A12A REM

2,727 TAN 00,1896 N02B REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

OvaMit,Tablet

Clomifene Citrate BP

50 mg

60

Remedica Ltd.
CYPRUS

Atenolol BP

50 mg

60

Remedica Ltd.
CYPRUS

Atenolol BP

100 mg

60

Remedica Ltd.
CYPRUS

Captopril BP

25 mg

36

Remedica Ltd.
CYPRUS

Tamoxifen Citrate BP

10 mg

60

Remedica Ltd.
CYPRUS

Calcium Lactate BP

300 mg

60

Remedica Ltd.
CYPRUS

Diclofenac Sodium BP

100 mg

60

Remedica Ltd.
CYPRUS

Velorin,Tablet

Velorin,Tablet

Epsitoron,Tablet

Novofen,Tablet

Calcium Lactate,Tablet

Remethan,Tablet

Page 433 of 584

Human Medicinal Products


S/No:

Registration Number

2,728 TAN 00,2192 J01F REM

2,729 TAN 00,2191 J01D REM

2,730 TAN 00,2191 J01D REM

2,731 TAN 00,2190 J02A REM

2,732 TAN 00,2393 C03C REM

2,733 TAN 00,2393 C03C REM

2,734 TAN 00,2629 J01K REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Clarisol,Tablet

Clarithromycin USP

500 mg

36

Remedica Ltd.
CYPRUS

Cefaclor BP

250 mg

36

Remedica Ltd.
CYPRUS

Cefaclor Monohydrate BP
Cefaclor BP

265 mg
250 mg

36

Remedica Ltd.
CYPRUS

Fluconazole BP

150 mg

36

Remedica Ltd.
CYPRUS

Frusemide BP

40 mg

60

Remedica Ltd.
CYPRUS

Frusemide BP

40 mg

60

Remedica Ltd.
CYPRUS

36

Remedica Ltd.
CYPRUS

Remeclor,Capsules

Remeclor,Capsules

Dilapan,Capsules

Salurex,Tablet

Salurex,Tablet

Zindolin,Tablet

Ciprofloxacin Hydrochloride 250 mg


BP

Page 434 of 584

Human Medicinal Products


S/No:

Registration Number

2,735 TAN 00,2630 J01K REM

2,736 TAN 00,2631 H03B REM

2,737 TAN 00,2633 N04B REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,739 TAN 00,4383 N05A REM

2,740 TAN 00,4380 V07A REM

2,741 TAN 00,4381 A04A REM

Manufacturer

Zindolin,Tablet

Ciprofloxacin Hydrochloride 500 mg


BP

36

Remedica Ltd.
CYPRUS

Carbimazole BP

5 mg

60

Remedica Ltd.
CYPRUS

5 mg

60

Remedica Ltd.
CYPRUS

Chlorpromazine
Hydrochloride BP

100 mg

60

Remedica Ltd.
CYPRUS

Imipramine Hydrochloride
BP

25 mg

24

Remedica Ltd.
CYPRUS

Trihexyphenidyl
Hydrochloride BP

5 mg

24

Remedica Ltd.
CYPRUS

10 mg

60

Remedica Ltd.
CYPRUS

Carbimazole,Tablet

Trifluoperazine,Tablet

Trifluoperazine (as
Hydrochloride) BP

2,738 TAN 00,2635 N04B REM

Shelf life
month

Chlorpromazine,Tablet

Imipramine,Tablet

Benzhexol,Tablet

Peptomet FC,Tablet

Domperidone BP

Page 435 of 584

Human Medicinal Products


S/No:

Registration Number

2,742 TAN 00,2030 M01A REM

2,743 TAN 00,4626 P01A REM

2,744 TAN 00,4624 M01A REM

2,745 TAN 00,4625 M01A REM

2,746 TAN 00,833 J01H REM

2,747 TAN 00,834 J01C REM

2,748 TAN 00,835 A03B REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Roxitan,Capsules

Piroxicam BP

20 mg

60

Remedica Ltd.
CYPRUS

Tinidazole BP

500 mg

60

Remedica Ltd.
CYPRUS

Mefenamic Acid BP

250 mg

60

Remedica Ltd.
CYPRUS

Naproxen BP

500 mg

24

Remedica Ltd.
CYPRUS

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

60

Remedica Ltd.
CYPRUS

Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

60

Remedica Ltd.
CYPRUS

Hyoscine Butylbromide BP

36

Remedica Ltd.
CYPRUS

Tinirem,Tablet

Alfoxan,Capsules

Priaxen,Tablet

Amoxapen,Capsules

Cloxacillin,Capsules

Dividol,Tablet

Page 436 of 584

10 mg

Human Medicinal Products


S/No:

Registration Number

2,749 TAN 00,836 N02B REM

2,750 TAN 00,837 C01D REM

2,751 TAN 00,838 P01B REM

2,752 TAN 00,839 C01D REM

2,753 TAN 00,840 J01G REM

2,754 TAN 00,841 D04A REM

2,755 TAN 00,1192 J01D REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Remethan,Tablet

Diclofenac Sodium BP

50 mg

60

Remedica Ltd.
CYPRUS

Nifedipine BP

10 mg

36

Remedica Ltd.
CYPRUS

Quinine Sulphate BP

300 mg

60

Remedica Ltd.
CYPRUS

Nifedipine BP

20 mg

36

Remedica Ltd.
CYPRUS

Eryrthromycin Stearate BP

250 mg

60

Remedica Ltd.
CYPRUS

Diclofenac
Diethylammonium
equivalent to Diclofenac
Sodium BP

1 %w/w

36

Remedica Ltd.
CYPRUS

Cephalexin Monohydrate
equivalent to Cephalexin
Anhydrous BP

125 mg/5ml

36

Remedica Ltd.
CYPRUS

Nifelat,Tablet

Quinine Sulphate,Tablet

Nifelat R,Tablet

Ermycin,Tablet

Remethan,Gel

Felexin,Suspension

Page 437 of 584

Human Medicinal Products


S/No:

Registration Number

2,756 TAN 00,1193 J01H REM

2,757 TAN 00,1194 N02B REM

2,758 TAN 00,1195 J01F REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Cephalexin Monohydrate
equivalent to Cephalexin
Anhydrous BP

250 mg

60

Remedica Ltd.
CYPRUS

Haloperidol BP

1.5 mg

60

Remedica Ltd.
CYPRUS

125 mg/5ml

36

Remedica Ltd.
CYPRUS

60

Remedica Ltd.
CYPRUS

Haloxen,Tablet

Ermyced,Suspension

Hydralazine,Tablet

Hydralazine Hydrochloride 25 mg
BP

2,760 TAN 00,1197 C03A REM

2,761 TAN 00,1199 C01D REM

2,762 TAN 00,1200 A01B REM

Manufacturer

Felexin,Capsules

Erythromycin
EthylSuccinate BP

2,759 TAN 00,1196 C04A REM

Shelf life
month

Acetazolamide,Tablet

Acetazolamide BP

250 mg

60

Remedica Ltd.
CYPRUS

Verapamil Hydrochloride
BP

40 mg

60

Remedica Ltd.
CYPRUS

Metformin Hydrochloride
USP

500 mg

60

Remedica Ltd.
CYPRUS

Caveril,Tablet

Glyformin,Tablet

Page 438 of 584

Human Medicinal Products


S/No:

Registration Number

2,763 TAN 00,1201 J01H REM

2,764 TAN 00,1202 J01H REM

2,765 TAN 00,1203 V03A REM

2,766 TAN 00,1205 A06A REM

2,767 TAN 00,1206 M04A REM

2,768 TAN 00,1207 J01H REM

2,769 TAN 00,1209 A02B REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Amoxapen,Suspension

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

36

Remedica Ltd.
CYPRUS

Ampicillin Trihydrate eq to
Ampicillin BP

250 mg

60

Remedica Ltd.
CYPRUS

Griseofulvin BP

500 mg

60

Remedica Ltd.
CYPRUS

Bisacodyl BP

5 mg

60

Remedica Ltd.
CYPRUS

Allopurinol BP

100 mg

60

Remedica Ltd.
CYPRUS

Doxycycline Hydrochloride
BP

100 mg

60

Remedica Ltd.
CYPRUS

Cimetidine BP

400 mg

60

Remedica Ltd.
CYPRUS

Penodil,Capsules

Griseofulvin,Tablet

Bisacodyl,Tablet

Alopron,Tablet

Remycin,Capsules

Tenomet,Tablet

Page 439 of 584

Human Medicinal Products


S/No:

Registration Number

2,770 TAN 00,1210 A10B REM

2,771 TAN 00,1211 A10B REM

2,772 TAN 00,1212 P01B REM

2,773 TAN 00,1213 R03A REM

2,774 TAN 00,1214 J01H REM

2,775 TAN 00,1215 N04A REM

2,776 TAN 00,1216 N03A REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Chlorpropamide,Tablet

Chlorpropamide BP

250 mg

60

Remedica Ltd.
CYPRUS

Glibenclamide BP

5 mg

60

Remedica Ltd.
CYPRUS

Pyrimethamine BP
Sulfadoxine BP

25 mg
500 mg

60

Remedica Ltd.
CYPRUS

Ketotifen Fumarate BP

1 mg

60

Remedica Ltd.
CYPRUS

Flucloxacillin Sodium BP

250 mg

60

Remedica Ltd.
CYPRUS

Bromocriptine Mesylate BP

2.5 mg

36

Remedica Ltd.
CYPRUS

Carbamazepine BP

200 mg

60

Remedica Ltd.
CYPRUS

Glitisol,Tablet

Falcistat,Tablet

Licoften,Tablet

Ramaxir,Capsules

Brameston,Tablet

Storilat,Tablet

Page 440 of 584

Human Medicinal Products


S/No:

Registration Number

2,777 TAN 00,1217 J02A REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,779 TAN 00,1221 A07A REM

2,780 TAN 00,1222 C01K REM

2,781 TAN 00,1223 P02X REM

2,782 TAN 00,1204 N05A REM

2,783 TAN 05,813 N04C REM

Manufacturer

Ketrozol,Tablet
200 mg

60

Remedica Ltd.
CYPRUS

Thiabendazole BP

500 mg

60

Remedica Ltd.
CYPRUS

Nystatin BP

500,000 IU

60

Remedica Ltd.
CYPRUS

Methyldopa BP

250 mg

60

Remedica Ltd.
CYPRUS

Albendazole BP

200 mg

60

Remedica Ltd.
CYPRUS

Amitriptyline Hydrochloride 25 mg
BP

60

Remedica Ltd.
CYPRUS

Lorazepam BP

60

Remedica Ltd.
CYPRUS

Ketoconazole USP

2,778 TAN 00,1220 P02X REM

Shelf life
month

Tiabendazole,Tablet

Restatin,Tablet

Methyldopa,Tablet

Zestaval,Tablet

Amirol,Tablet

Lorivan 1,Tablet

Page 441 of 584

1 mg

Human Medicinal Products


S/No:

Registration Number

2,784 TAN 05,811 N03A REM

2,785 TAN 05,812 N04C REM

2,786 TAN 06,099 P02A REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,788 TAN 06,100 C04A REM

2,789 TAN 00,1892 A12A REM

Sodium Valproate BP

200 mg

36

Remedica Ltd.
CYPRUS

Lorazepam BP

2 mg

60

Remedica Ltd.
CYPRUS

600 mg

36

Remedica Ltd.
CYPRUS

Clavulinic Acid BP
Amoxicillin Trihydrate BP

125 mg
250 mg

24

Remedica Ltd.
CYPRUS

Isosorbide Dinitrate BP

10 mg

60

Remedica Ltd.
CYPRUS

300

60

Remedica Ltd.
CYPRUS

300

60

Remedica Ltd.
CYPRUS

Lorivan 2,Tablet

Praziquantel 600,Tablet

Clavomid 375,Tablet

Isorem 10,Tablet

Calcium Lactate,Tablet

Calcium Lactate BP

2,790 TAN 00,1892 A12A REM

Manufacturer

Petilin 200 EC,Tablet

Prazinquatel USP

2,787 TAN 06,098 J01C REM

Shelf life
month

Calcium Lactate,Tablet

Calcium Lactate BP

Page 442 of 584

Human Medicinal Products


S/No:

Registration Number

2,791 TAN 06,097 C01B REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,793 TAN 00,2190 J02A REM

2,794 TAN 00,2192 J01F REM

60

Remedica Ltd.
CYPRUS

36

Remedica Ltd.
CYPRUS

36

Remedica Ltd.
CYPRUS

500 mg

36

Remedica Ltd.
CYPRUS

5 mg

60

Remedica Ltd.
CYPRUS

Trifluoperazine (as
Hydrochloride) BP

5 mg

60

Remedica Ltd.
CYPRUS

Spironolactone BP

25 mg

60

Remedica Ltd.
CYPRUS

Dilapan,Capsules

Clarem,Tablet

Trifluoperazine,Tablet

Trifluoperazine (as
Hydrochloride) BP

2,796 TAN 00,2633 N04B REM

2,797 TAN 00,1677 C01D REM

200 mg

Dilapan,Capsules

Clarithromycin Ph Eur

2,795 TAN 00,2633 N04B REM

Manufacturer

Cardilor,Tablet

Amiodarone Hydrochloride
BP

2,792 TAN 00,2190 J02A REM

Shelf life
month

Trifluoperazine,Tablet

Spirolon,Tablet

Page 443 of 584

Human Medicinal Products


S/No:

Registration Number

2,798 TAN 00,1680 G04A REM

2,799 TAN 00,1682 D01A REM

2,800 TAN 00,1893 A07D REM

2,801 TAN 00,1894 C06A REM

2,802 TAN 00,1897 H02A REM

2,803 TAN 00,4382 L02B REM

2,804 TAN 00,4626 P01A REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Nalidixic Acid,Tablet

Nalidixic Acid BP

500 mg

60

Remedica Ltd.
CYPRUS

Clotrimazole BP

1 %w/w

36

Remedica Ltd.
CYPRUS

Loperamide Hydrochloride
BP

2 mg

60

Remedica Ltd.
CYPRUS

Propranolol Hydrochloride
BP

40 mg

60

Remedica Ltd.
CYPRUS

Dexamethasone BP

0.5 mg

60

Remedica Ltd.
CYPRUS

Tamoxifen Citrate BP

20 mg

60

Remedica Ltd.
CYPRUS

Tinidazole BP

500

60

Remedica Ltd.
CYPRUS

Mycoril,Cream

Loperium,Tablet

Emforal,Tablet

Perazone,Tablet

Novofen,Tablet

Tinirem,Tablet

Page 444 of 584

Human Medicinal Products


S/No:

Registration Number

2,805 TAN 00,4626 P01A REM

2,806 TAN 00,4624 M01A REM

2,807 TAN 00,4624 M01A REM

2,808 TAN 00,4625 M01A REM

2,809 TAN 00,4625 M01A REM

2,810 TAN 00,2632 G04B REM

2,811 TAN 06,099 P02A REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Tinirem,Tablet

Tinidazole BP

500

60

Remedica Ltd.
CYPRUS

Mefenamic Acid BP

250 mg

60

Remedica Ltd.
CYPRUS

Mefenamic Acid BP

250 mg

60

Remedica Ltd.
CYPRUS

Naproxen BP

500

24

Remedica Ltd.
CYPRUS

Naproxen BP

500

24

Remedica Ltd.
CYPRUS

Allopurinol BP

300 mg

60

Remedica Ltd.
CYPRUS

600 mg

36

Remedica Ltd.
CYPRUS

Alfoxan,Capsules

Alfoxan,Capsules

Priaxen,Tablet

Priaxen,Tablet

Alopron,Tablet

Praziquantel 600,Tablet

Prazinquatel USP

Page 445 of 584

Human Medicinal Products


S/No:

Registration Number

2,812 TAN 06,099 P02A REM

Product Name
Pack and Pack size

Ingredient(s) and Strength

600 mg

36

Remedica Ltd.
CYPRUS

125 mg
250 mg

24

Remedica Ltd.
CYPRUS

Clavulinic Acid BP
Amoxicillin Trihydrate BP

125 mg
250 mg

24

Remedica Ltd.
CYPRUS

Isosorbide Dinitrate BP

10 mg

60

Remedica Ltd.
CYPRUS

Isosorbide Dinitrate BP

10 mg

60

Remedica Ltd.
CYPRUS

36

Remedica Ltd.
CYPRUS

36

Remedica Ltd.
CYPRUS

Clavomid 375,Tablet

Clavulinic Acid BP
Amoxicillin Trihydrate BP

2,814 TAN 06,098 J01C REM

2,815 TAN 06,100 C04A REM

2,816 TAN 06,100 C04A REM

2,817 TAN 00,2190 J02A REM

2,818 TZ11H170

Manufacturer

Praziquantel 600,Tablet

Prazinquatel USP

2,813 TAN 06,098 J01C REM

Shelf life
month

Clavomid 375,Tablet

Isorem 10,Tablet

Isorem 10,Tablet

Dilapan,Capsules

Aremed 1,Tablet

Anastrozole Ph Eur

Page 446 of 584

1 mg

Human Medicinal Products


S/No:

Registration Number

2,819 TAN 06,097 C01B REM

2,820 TAN 06,097 C01B REM

Registrant
2,821 TAN 00,2194 J01C RIP

2,822 TAN 00,2193 J01F RIP

2,823 TAN 00,2637 J01C RIP

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,824 TAN 05,023 C06A FLR

Manufacturer

Cardilor,Tablet

Amiodarone Hydrochloride
BP

200 mg

60

Remedica Ltd.
CYPRUS

Amiodarone Hydrochloride
BP

200 mg

60

Remedica Ltd.
CYPRUS

Ampicillin Trihydrate
equivalent to Ampicillin BP
Cloxacillin Sodium
equivalent to Cloxacillin
USP

250 mg

24

Riva Pharma S.A.E


EGYPT

Azithromycin USP

250 mg

24

Riva Pharma S.A.E


EGYPT

125 mg/5ml

24

Riva Pharma S.A.E


EGYPT

36

Roche Diagnostics GmbH


GERMANY

Cardilor,Tablet

Riva Pharma S.A.E - EGYPT


Rivaclox,Capsules

250 mg

Zithroriv,Capsules

Rivaclox,Suspension

Ampicillin Trihydrate
equivalent to Ampicillin BP
Cloxacillin Sodium
equivalent to Cloxacillin
USP

Registrant

Shelf life
month

125 mg/5ml

Roche Diagnostics GmbH - GERMANY


Dilatrend,Tablet

Carvedilol IH

Page 447 of 584

6.25 mg

Human Medicinal Products


S/No:

Registration Number

2,825 TAN 05,174 B06A FLR

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,827 TAN 00,2198 P01B ROT

2,828 TAN 00,4252 C03C ROT

Quinine
Dihydrochloride,Injectable
Quinine Hydrochloride BP
Solution

Pancuronium,Injectable
Solution

Suxamethonium
Chloride,Injectable Solution

Suxamethonium Chloride
BP

Registrant

Roche Diagnostics GmbH


GERMANY

5000 IU

24

Roche Diagnostics GmbH


GERMANY

600 mg/2ml

48

Rotexmedica GMBH
GERMANY

10 mg/ml

36

Rotexmedica GMBH
GERMANY

2 mg/ml

24

Rotexmedica GMBH
GERMANY

100 mg

24

Rotexmedica GMBH
GERMANY

Frusemide,Injectable Solution

Pancuronium Bromide Ph
Eur

2,830 TAN 08,155 N04A ROT

24

Rotexmedica GMBH - GERMANY

Frusemide BP

2,829 TAN 07,399 N01A ROT

2000 IU

Recormon,Injectable Solution

Erythropoietin IH

Registrant

Manufacturer

Recormon,Injectable Solution

Erythropoietin IH

2,826 TAN 05,175 B06A FLR

Shelf life
month

S K AGE Exports - INDIA

Page 448 of 584

Human Medicinal Products


S/No:

Registration Number

2,831 TAN 00,430 S01D ALC

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,833 TAN 00,582 S01D ALC

Tears Naturale II
Lubricant,Ophthalmic
Dextran 70 JP
Solution

Isopto Carpine,Ophthalmic
Solution

Pilocarpine Hydrochloride
Ph Eur

2,835 TAN 00,583 S01D ALC

Isopto Carpine,Ophthalmic
Solution

Pilocarpine Hydrochloride
Ph Eur

2,836 TAN 00,847 S01A ALC

S K AGE Exports
INDIA

1 mg/15ml

24

S K AGE Exports
INDIA

10 mg/ml

36

S K AGE Exports
INDIA

40 mg/ml

48

S K AGE Exports
INDIA

40 mg/ml

48

Hilton Pharma (PVT) Ltd.


PAKISTAN

1 mg/ml

24

S K AGE Exports
INDIA

1 mg/ml

24

Hilton Pharma (PVT) Ltd.


PAKISTAN

2.5 mg/ml

Alomide,Ophthalmic Solution

Lodoxamide IH

2,837 TAN 00,847 S01A ALC

36

1.2 mg/ml

Cyclogyl,Ophthalmic Solution

Cyclopentolate
Hydrochloride Ph Eur

2,834 TAN 00,583 S01D ALC

Manufacturer

Zincfrin,Ophthalmic Solution

Phenylephrine
Hydrochloride Ph Eur
Zinc Sulphate Ph Eur
2,832 TAN 00,581 S01D ALC

Shelf life
month

Alomide,Ophthalmic Solution

Lodoxamide IH

Page 449 of 584

Human Medicinal Products


S/No:

Registration Number

2,838 TAN 00,435 S01B ALC

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,840 TAN 00,581 S01D ALC

2,841 TAN 00,582 S01D ALC

1 mg/ml

36

S K AGE Exports
INDIA

Tears Naturale II
Lubricant,Ophthalmic
Dextran 70 JP
Solution

24

S K AGE Exports
INDIA

Tears Naturale II
Lubricant,Ophthalmic
Dextran 70 JP
Solution

24

S K AGE Exports
INDIA

10

36

S K AGE Exports
INDIA

10

36

S K AGE Exports
INDIA

40

48

S K AGE Exports
INDIA

40

48

S K AGE Exports
INDIA

Cyclogyl,Ophthalmic Solution

Cyclopentolate
Hydrochloride Ph Eur

2,842 TAN 00,582 S01D ALC

Cyclogyl,Ophthalmic Solution

Cyclopentolate
Hydrochloride Ph Eur

2,843 TAN 00,583 S01D ALC

Isopto Carpine,Ophthalmic
Solution

Pilocarpine Hydrochloride
Ph Eur

2,844 TAN 00,583 S01D ALC

Manufacturer

Maxidex,Ophthalmic Solution

Dexamethasone Ph Eur

2,839 TAN 00,581 S01D ALC

Shelf life
month

Isopto Carpine,Ophthalmic
Solution

Pilocarpine Hydrochloride
Ph Eur

Page 450 of 584

Human Medicinal Products


S/No:

Registration Number

2,845 TAN 00,584 S01C ALC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Maxitrol,Ophthalmic
suspension

S K AGE Exports
INDIA

24

S K AGE Exports
INDIA

1 mg/ml

24

S K AGE Exports
INDIA

Lodoxamide IH

1 mg/ml

24

S K AGE Exports
INDIA

Dexamethasone Ph Eur
Neomycin Ph Eur
Polymyxin B Sulphate Ph
Eur

1 mg/g
3500 IU/g
6000 IU/g

48

S K AGE Exports
INDIA

24

S K AGE Exports
INDIA

36

S K AGE Exports
INDIA

Maxitrol,Ophthalmic
suspension

1
Dexamethasone Ph Eur
Neomycin Sulphate Ph Eur 35000
6000
Polymyxin B Sulphate Ph
Eur

2,847 TAN 00,847 S01A ALC

Alomide,Ophthalmic Solution

Lodoxamide IH

2,848 TAN 00,847 S01A ALC

2,849 TAN 05,814 S01C S.A

2,850 TAN 06,101 J01K S.A

Alomide,Ophthalmic Solution

Maxitrol,Ointment

Ciloxan,Ophthalmic Ointment

Ciprofloxacin Hydrochloride 3 mg/g


IH

2,851 TAN 00,435 S01B ALC

Manufacturer

24

1
Dexamethasone Ph Eur
Neomycin Sulphate Ph Eur 35000
6000
Polymyxin B Sulphate Ph
Eur

2,846 TAN 00,584 S01C ALC

Shelf life
month

Maxidex,Ophthalmic Solution

Dexamethasone Ph Eur

Page 451 of 584

1 mg/ml

Human Medicinal Products


S/No:

Registration Number

2,852 TAN 06,331 J01K S.A

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,854 TAN 06,332 S01D S.A

2,855 TAN 07,219 H02A S K

2,856 TAN 00,954 J01H SKT

2,857 TAN 00,959 J03B SKT

2,858 TAN 00,429 J01K ALC

Manufacturer

Tobrex,Ophthalmic Ointment
3 mg/g

60

S K AGE Exports
INDIA

Dexamethasone Phosphate 1 mg/g


Ph Eur

48

S K AGE Exports
INDIA

Tobramycin Sulphate Ph
Eur

2,853 TAN 06,333 H02A S.A

Shelf life
month

Maxidex,Ophthalmic
Ointment

Isopto Carpine,Ophthalmic
Solution

Pilocarpine Hydrochloride
Ph Eur

20 mg/ml

48

S K AGE Exports
INDIA

Prednisolone BP

5 mg

36

S Kant Healthcare Ltd


INDIA

Ampicillin Trihydrate eq to
Ampicillin BP

125 mg/5ml

24

S Kant Healthcare Ltd


INDIA

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

24

S K AGE Exports
INDIA

3 mg/ml

36

S K AGE Exports
INDIA

Prednikant,Tablet

Ampikant,Syrup

Cotrikant,Tablet

Tobrex,Ophthalmic Solution

Tobramycin Sulphate Ph
Eur

Page 452 of 584

Human Medicinal Products


S/No:

Registration Number

2,859 TAN 00,431 S03D ALC

Product Name
Pack and Pack size

Ingredient(s) and Strength

1 %w/w

36

S K AGE Exports
INDIA

250 mg

24

S Kant Healthcare Ltd


INDIA

Quinine Sulphate BP

300 mg

36

S Kant Healthcare Ltd


INDIA

Acyclovir BP

200 mg

36

S Kant Healthcare Ltd


INDIA

6.8 mg/ml

24

S K AGE Exports
INDIA

3 mg/ml
3 mg/ml

36

S K AGE Exports
INDIA

Chlorokant,Capsules

Chloramphenicol BP

2,861 TAN 09,223 P01B SK

Manufacturer

Mydriacyl,Solution

Tropicamide Ph Eur

2,860 TAN 00,955 J01B SKT

Shelf life
month

Quinine Sulphate,Tablet

2,862 TAN 10, 043 J043 J05A SKAAvirax,Tablet

2,863 TZ11H167

Azarga,Eye drop suspension

Timolol Maleate Ph Eur

2,864 TAN 00,429 J01K ALC

Tobrex,Ophthalmic Solution

Tobramycin Ph Eur
Tobramycin Sulphate Ph
Eur

Registrant

S Kant Healthcare Ltd - INDIA

Page 453 of 584

Human Medicinal Products


S/No:

Registration Number

2,865 TAN 07,218 J01F S K

2,866 TAN 00,962 NJ01H SKT

2,867 TAN 00,1245 J01H SKT

2,868 TAN 00,1246 J01K SKT

2,869 TAN 00,960 N02B SKT

2,870 TAN 00,961 J01K SKT

2,871 TAN 08,020 C01C S K

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Erythrokant,Tablet

Erythromycin Stearate eq to 250 mg


Erythromycin BP

36

S Kant Healthcare Ltd


INDIA

Ampicillin Trihydrate
equivalent to Ampicillin BP

24

S Kant Healthcare Ltd


INDIA

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

24

S Kant Healthcare Ltd


INDIA

Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

24

S Kant Healthcare Ltd


INDIA

Paracetamol BP

500 mg

24

S Kant Healthcare Ltd


INDIA

Ciprofloxacin Hydrochloride 500 mg


USP

24

S Kant Healthcare Ltd


INDIA

Propanolol BP

36

S Kant Healthcare Ltd


INDIA

Ampikant,Capsules
250 mg

Amoxykant,Syrup

Cloxicant,Capsules

Parakant,Tablet

Ciprokant,Tablet

Propranolol,Tablet

Page 454 of 584

40 mg

Human Medicinal Products


S/No:

Registration Number

2,872 TAN 08,109 J03C S K

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,873 TAN 00,2396 D11A SAM

36

S Kant Healthcare Ltd


INDIA

50 mg/g

36

Samchully Pharm. Co, Ltd.


KOREA

2,874 TAN 05,533 J04A SAN

Ethambutol Hydrochloride
USP
Isoniazid USP
Pyrazinamide USP
Rifampicin USP

275 mg

36

Strides Arcolab Ltd


INDIA

2,875 TAN 05,532 J04A SAN

Isoniazid BP
Rifampicin BP

75 mg
150 mg

24

Strides Arcolab Ltd


INDIA

Registrant
2,876 TZ10H079

100 IU/ml

24

1 %w/w

Samchully Pharm. Co, Ltd. - KOREA


Vacrax,Cream

Acyclovir BP

Registrant

Manufacturer

SilverKant,Cream

Silver Sulphadiazine USP

Registrant

Shelf life
month

Sandoz Private Ltd. - INDIA


Rimstar 4-FDC,Tablet

75 mg
400 mg
150 mg

Rimactazid,Tablet

Sanofi - Aventis - FRANCE


Insuman Basal,Injectable
suspension

Human Insulin IH

Page 455 of 584

Sanofi-Aventis Deutschland
GmbH
GERMANY

Human Medicinal Products


S/No:

Registration Number

2,877 TZ10H080

Product Name
Pack and Pack size

Ingredient(s) and Strength

Insuman Basal,Injectable
suspension

Human Insulin IH

Registrant
2,878 TAN 00,425 G03B SAN

2,881 TAN 00,4194 J07A AVE

2,882 TAN 00,4193 J06B AVE

Sanofi-Aventis Deutschland
GmbH
GERMANY

Danol,Capsules
200 mg

60

Sanofi-Synthelabo
UNITED KINGDOM

30 IU
60 IU
4 IU

36

Aventis Pasteur S.A


FRANCE

2 mg/ml
Carbocisteine Ph Eur
Promethazine Hydrochloride 0.05 mg/ml
Ph Eur

36

Sanofi Winthrop Industrie


FRANCE

Purified VI Capsular
Polysaccharide of
Salmonella typhi (Ty 2
Strain) IH

0.025 mg/0.5ml

24

Sanofi Pasteur
FRANCE

1500 IU/ml

36

Aventis Pasteur S.A


FRANCE

DTP + DT Coq,Injection

Diphtheria Toxoid IH
Tetanus Antitoxin IH
Brinzolamide IH
2,880 TAN 00,2170 R06A LSB

24

Manufacturer

Sanofi - Aventis Kenya Limited - KENYA


Danazol USP

2,879 TAN 09,096 V03A AVE

100 IU/ml

Shelf life
month

Rhinathiol
Promethazine,Syrup

Typhim VI,Solution

Tetanea,Solution for Injection

Tetanus Immunoglobulin F
IH

Page 456 of 584

Human Medicinal Products


S/No:

Registration Number

2,883 TAN 00,4584 J07A AVE

2,884 TAN 00,4586 B01A AVE

2,885 TAN 00,4586 B01A AVE

2,886 TAN 00,4589 B01A AVE

2,887 TAN 00,4585 B01A AVE

2,888 TAN 00,4588 B01A AVE

2,889 TAN 05,079 V02C SAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Verorab,Powder
Aventis Pharma S.A
FRANCE

Inactivated Rabies Virus Ph 2.3 IU


Eur

36

Enoxaparin Sodium Ph Eur 100 mg/ml

24

Enoxaparin Sodium Ph Eur 100 mg/ml

24

Enoxaparin Sodium USP

100 mg/ml

24

Aventis Pharma Specialties


FRANCE

Enoxaparin Sodium Ph Eur 100 mg/ml

24

Aventis Pharma Specialties


FRANCE

Enoxaparin Sodium USP

100mg mg/ml

24

Aventis Pharma Specialties


FRANCE

2 g/100ml

24

Sanofi Winthrop Industrie


FRANCE

Clexane,Solution
Marck Parenterals (India)
Limited
INDIA

Clexane,Solution
Marck Parenterals (India)
Limited
INDIA

Clexane,Solution

Clexane,Solution

Clexane,Solution

Rhinathiol Enfants,Syrup

Carbocisteine Ph Eur

Page 457 of 584

Human Medicinal Products


S/No:

Registration Number

2,890 TAN 05,089 A10B AVE

2,891 TAN 05,090 A10B AVE

2,892 TAN 05,091 A10B AVE

2,893 TAN 05,087 C01E AVE

2,894 TAN 05,088 C01E AVE

2,895 TAN 05,141 A02A AVE

2,896 TAN 05,143 A02A AVE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Amaryl,Tablet

Glimepiride IH

2 mg

48

Glimepiride BP

1 mg

48

Glimepiride BP

4 mg

60

Felodipine Ph Eur
Ramipril Ph Eur

2.5 mg
2.5 mg

24

Felodipine Ph Eur
Ramipril Ph Eur

5 mg
5 mg

24

Magnesium
Hydroxide(Equivalent to
Magnesium Hydroxide
Paste USP

206 mg/5ml

36

Sanofi-Aventis Deutschland
GmbH
GERMANY

Amaryl,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Amaryl,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Tri - Plen,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Tri - Plen Forte,Tablet


Sanofi-Aventis Deutschland
GmbH
GERMANY

Maalox,Suspension

Maalox Plus,Suspension

Page 458 of 584

Aventis Pharma S.p.A


ITALY

Human Medicinal Products


S/No:

Registration Number

2,897 TAN 05,142 A02A AVE

2,898 TAN 05,463 A10A AVE

2,899 TAN 05,464 D04A AVE

2,900 TAN 05,576 J04A AVE

2,901 TAN 05,736 C01K AVE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

36

Aventis Pharma S.p.A


ITALY

25 mg
200 mg/ml

24

Aventis Pharma S.p.A


ITALY

100 IU/ml

24

Promethazine Hydrochloride 5 mg/5ml


Ph Eur

24

Aventis Pharma (Pty), Ltd.


SOUTH AFRICA

Isoniazid BP
Rifampicin BP

150 mg
300 mg

24

Aventis Pharma (Pty), Ltd.


SOUTH AFRICA

Ramipril IH

2.5 mg

24

Magnesium Hydroxide IH
Aluminium Hydroxide wet
gel equivalent to dried
Aluminium Hydroxide gel
IH
Simethicone USP

200 mg
200 mg

Simethicone USP
Aluminium Hydroxide wet
gel equivalent to dried
Aluminium Hydroxide gel
USP/EP

Insulin Regular IH

25 mg

Maalox Plus,Tablet

Lantus,Solution
Sanofi-Aventis Deutschland
GmbH
GERMANY

Phenergan,Elixir

Rifinah,Tablet

Tritace,Tablet

Page 459 of 584

Sanofi-Aventis Deutschland
GmbH
GERMANY

Human Medicinal Products


S/No:

Registration Number

2,902 TAN 05,734 C01K AVE

2,903 TAN 05,733 C01K AVE

2,904 TAN 05,735 A10A AVE

2,905 TAN 06,015 V07A AVE

2,906 TAN 06,016 J07A AVE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Tritace,Capsules
Sanofi-Aventis Deutschland
GmbH
GERMANY

Ramipril IH

10 mg

24

Ramipril IH

5 mg

36

Insulin Glargine USP

100 IU/ml

24

Purified Tetanus Toxoid IH

40 IU/0.5ml

36

Aventis Pharma S.A


FRANCE

2.5 %w/v

36

SBL Vaccine
SWEDEN

50 mcg

36

Aventis Pharma S.A


FRANCE

Tritace,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Lantus,Injection
Sanofi-Aventis Deutschland
GmbH
GERMANY

Tetavax,Powder

Dukoral,Injectable Solution

Vibrio choleral IH

2,907 TAN 06,013 V07A AVE

Shelf life
month

Meningococcal Polysaccharide
Vaccine A + C,Injectable
Vaccinum Meningitides
Solution

Cerebrospinalis IH

Page 460 of 584

Human Medicinal Products


S/No:

Registration Number

2,908 TAN 06,014 J07A AVE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Fav - Afrique,Injectable
Solution

Bitis gabonica venom Ph


Eur
Echis leucogaster venom Ph
Eur
Bitis arietans venom Ph Eur
Echis ocellatus venom Ph
Eur
Naja haje venom Ph Eur
Naja melanoleuca venom Ph
Eur
Naja nigricollis venom Ph
Eur
Dendaspis viridis venom Ph
Eur
Dendrosapis polylepsis
venom Ph Eur
Dendroaspis jamesoni
venom Ph Eur

2,909 TAN 06,017 J01K AVE

Aventis Pasteur S.A


FRANCE

>250 LD50/10ml
>250 LD50/10ml
>250 LD50/10ml
>250 LD50/10ml
>250 LD50/10ml
>250 LD50/10ml
>250 LD50/10ml
>250 LD50/10ml
>250 LD50/10ml

Sanofi-Aventis Deutschland
GmbH
GERMANY

500 mg

36

250 mg

36

Usiphar
FRANCE

36

Sanofi - Aventis
FRANCE

Tavanic,Injectable Solution

Levofloxacin Hemihydrate
IH

2,911 TAN 06,440 R06A SAN

36

Manufacturer

Tavanic,Injectable Solution

Levofloxacin Hemihydrate
IH

2,910 TAN 06,018 J01K AVE

>250 LD50/10ml

Shelf life
month

Rhinathiol
Promethazine,Syrup

2 g/100ml
Carbocisteine Ph Eur
Promethazine Hydrochloride 0.05 g/100ml
Ph Eur

Page 461 of 584

Human Medicinal Products


S/No:

Registration Number

2,912 TAN 06,439V07A SAN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Stamaril Pasteur,Freeze dried


powder for injection single
Attenueted Yellow fever Ph
dose

Eur

2,914 TAN 07,007 J07A AVE

Stamaril Pasteur,Freeze dried


powder for injection
Attenueted Yellow fever Ph
multidose

Eur

2,915 TAN 07,140 J01K AVE

2,917 TAN 00,361 C01B SAN

2,918 TAN 00,391 P01B SAN

24

Sanofi Winthrop Industrie


FRANCE

17 D/AB 237> 1000


LD50/0.5ml

36

Aventis Pasteur S.A


FRANCE

17 D/AB 237> 1000


LD50/0.5ml

36

Aventis Pasteur S.A


FRANCE

5 mg

Tavanic,Tablet
250 mg

36

500 mg
Paracetamol Ph Eur
Codeine Phosphate Ph Eur 8 mg
Drotaverine Hydrochloride 40 mg
IH

24

Amiodarone Hydrochloride
Ph Eur

36

Levofloxacin IH

2,916 TAN 07,226 M01A CHI

Manufacturer

Rhinathiol Adult,Syrup

Carbocisteine IH

2,913 TAN 07,008 J07A AVE

Shelf life
month

Sanofi-Aventis Deutschland
GmbH
GERMANY

Nospalgin,Tablet
Chinoin Pharmaceutical
and Chemical Works Co.Ltd
HUNGARY

Cordarone,Tablet

Quinimax,Tablet

Page 462 of 584

200 mg

Sanofi Winthrop Industrie


FRANCE

Human Medicinal Products


S/No:

Registration Number

2,919 TAN 00,394 P01B SAN

2,920 TAN 00,395 C01B SAN

2,921 TAN 07,268 C01L AVE

2,922 TAN 07,439 J07A AVE

2,923 TAN 00,1224 P01A RHO

Product Name
Pack and Pack size

Ingredient(s) and Strength

Cinchonidine Hydrochloride
IH
Cinchonine Hydrochloride
IH
Quinidine Hydrochloride IH
Quinine Dihydrochloride IH

0.85 mg

Cinchonidine Hydrochloride
IH
Cinchonine Hydrochloride
IH
Quinidine Hydrochloride IH
Quinine Hydrochloride IH

4.03 mg

Shelf life
month

Manufacturer

36

Sanofi Winthrop Industrie


FRANCE

36

Sanofi Winthrop Industrie


FRANCE

0.85 mg
3.3 mg
120 mg

Quinimax,Tablet

4.24 mg
15.42 mg
587.28 mg

Cordarone,Injection

Amiodarone Hydrochloride
Ph Eur

150 mg/ml

24

Sanofi Winthrop Industrie


FRANCE

Hydrochlorthiazide IH
Ramipril IH

25 mg
5 mg

24

Aventis Pharma
UNITED KINGDOM

Streptococcus Pneumonia
0.025 mg
Purified Polysaccharides IH

24

Aventis Pharma S.A


FRANCE

Secnidazole
Secnidazole IH

24

Famar-Lyon
FRANCE

Tritazide,Tablet

Pneumo 23 Polyvalent
Pneumococcal,Solution

Flagentyl,Tablet

Page 463 of 584

500 mg

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

2,924 TAN 09,200 N02B SAN

Co-proxamol,Tablet

Ingredient(s) and Strength

2,926 TAN 00,4584 J07A AVE

2,927 TAN 05,087 C01E AVE

2,928 TAN 05,087 C01E AVE

2,929 TAN 05,088 C01E AVE

Sanofi-Synthelabo
UNITED KINGDOM

Inactivated Rabies Virus Ph 2.3 IU


Eur

36

Aventis Pharma S.A


FRANCE

Inactivated Rabies Virus Ph 2.3 IU


Eur

36

Aventis Pharma S.A


FRANCE

Felodipine Ph Eur
Ramipril Ph Eur

2.5 mg
2.5 mg

24

Felodipine Ph Eur
Ramipril Ph Eur

2.5 mg
2.5 mg

24

5 mg
5 mg

24

5 mg
5 mg

24

325 mg
32.5 mg

Verorab,Powder

Verorab,Powder

Tri - Plen,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Tri - Plen,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Tri - Plen Forte,Tablet

Felodipine Ph Eur
Ramipril Ph Eur

2,930 TAN 05,088 C01E AVE

Manufacturer

60

Paracetamol Ph Eur
Dextropropoxyphene
Hydrochloride Ph Eur
2,925 TAN 00,4584 J07A AVE

Shelf life
month

Sanofi-Aventis Deutschland
GmbH
GERMANY

Tri - Plen Forte,Tablet

Felodipine Ph Eur
Ramipril Ph Eur

Page 464 of 584

Sanofi-Aventis Deutschland
GmbH
GERMANY

Human Medicinal Products


S/No:

Registration Number

2,931 TAN 05,089 A10B AVE

2,932 TAN 05,090 A10B AVE

2,933 TZ10H001

2,934 TAN 05,576 J04A AVE

2,935 TAN 05,576 J04A AVE

2,936 TAN 05,736 C01K AVE

2,937 TAN 05,736 C01K AVE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Amaryl,Tablet

Glimepiride IH

2 mg

48

Glimepiride IH

1 mg

48

Sanofi-Aventis Deutschland
GmbH
GERMANY

Amaryl,Tablet

Euvax B Adult (1.0ml)


Vaccine,Injectable Solution

Sanofi-Aventis Deutschland
GmbH
GERMANY

L.G. Household and Health


Care.
KOREA

Purified Hepatitis- B surface 20 mcg/1ml


antigen [HBsAg] IH

30

Isoniazid BP
Rifampicin BP

150 mg
300 mg

24

Aventis Pharma (Pty), Ltd.


SOUTH AFRICA

Isoniazid BP
Rifampicin BP

150 mg
300 mg

24

Aventis Pharma (Pty), Ltd.


SOUTH AFRICA

Ramipril IH

2.5 mg

24

Ramipril IH

2.5 mg

24

Rifinah,Tablet

Rifinah,Tablet

Tritace,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Tritace,Tablet

Page 465 of 584

Sanofi-Aventis Deutschland
GmbH
GERMANY

Human Medicinal Products


S/No:

Registration Number

2,938 TAN 05,734 C01K AVE

2,939 TAN 05,734 C01K AVE

2,940 TAN 05,733 C01K AVE

2,941 TAN 05,733 C01K AVE

2,942 TAN 05,735 A10A AVE

2,943 TAN 05,463 A10A AVE

Registrant

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Tritace,Capsules

Ramipril IH

10 mg

24

Ramipril IH

10 mg

24

Ramipril IH

5 mg

36

Ramipril IH

5 mg

36

Insulin Glargine USP

100 IU/ml

24

Insulin Glargine IH
Insulin Regular IH

100 mg/7.5ml
100 IU/ml

24

Sanofi-Aventis Deutschland
GmbH
GERMANY

Tritace,Capsules
Sanofi-Aventis Deutschland
GmbH
GERMANY

Tritace,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Tritace,Tablet
Sanofi-Aventis Deutschland
GmbH
GERMANY

Lantus,Injection
Sanofi-Aventis Deutschland
GmbH
GERMANY

Lantus,Solution

Sanofi Pasteur - KENYA

Page 466 of 584

Sanofi-Aventis Deutschland
GmbH
GERMANY

Human Medicinal Products


S/No:

Registration Number

2,944 TAN 00,4194 J07A AVE

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,946 TAN 00,4192 J07A AVE

24

Sanofi Pasteur
FRANCE

36

Sanofi Pasteur
FRANCE

24

Sanofi Pasteur
FRANCE

36

Sanofi Pasteur
FRANCE

36

Shantha Biotechnics Ltd.


INDIA

Purified Hepatitis B surface 20 mcg


antigen(HBsAg) BP

36

Shantha Biotechnics Ltd.


INDIA

Purified Hepatitis B surface 20 mcg/ml


antigen(HBsAg) IH

24

Shantha Biotechnics Ltd.


INDIA

25 mg/0.5ml

Act HIB,Lyophilized powder


for reconstitution

Typhim VI,Injectable Solution

Purified VI Capsular
Polysaccharide of
Salmonella typhi (Ty 2
Strain) Ph Eur
2,947 TAN 00,4193 J06B AVE

25 mg/0.5ml

Tetanea,Injectable Solution

Tetanus Immunoglobulin Ph 1500 IU


Eur

2,948 TAN 05,689 J07A SHA

Shanvac-B,Injection

Purified Hepatitis B surface 20 mcg


antigen(HBsAg) BP

2,949 TAN 05,689 J07A SHA

2,950 TAN 05,687 J07A SHA

Manufacturer

Typhim VI,Injectable Solution

Purified VI Capsular
Polysaccharide of
Salmonella typhi (Ty 2
Strain) Ph Eur
2,945 TAN 00,4191 J07A AVE

Shelf life
month

Shanvac-B,Injection

Shanvac-B,Solution

Page 467 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

2,951 TAN 05,687 J07A SHA

Shanvac-B,Solution

2,952 TAN 05,686 J07A SHA

2,953 TAN 05,686 J07A SHA

2,954 TAN 05,688 J07A SHA

Ingredient(s) and Strength

24

Shantha Biotechnics Ltd.


INDIA

Purified Hepatitis B surface 20 mcg/ml


antigen(HBsAg) IH

24

Shantha Biotechnics Ltd.


INDIA

Purified Hepatitis B surface 20 mcg/ml


antigen(HBsAg) IH

24

Shantha Biotechnics Ltd.


INDIA

24

Shantha Biotechnics Ltd.


INDIA

24

Shantha Biotechnics Ltd.


INDIA

36

Sanofi-Synthelabo S.A
SPAIN

Shanvac-B,Solution

Shanvac-B,Solution

Shanvac-B,Injectable Solution

Shanvac-B,Injectable Solution

Purified Hepatitis B surface 20 mcg/ml


antigen(HBsAg) IH

Registrant
2,956 TZ10H139

Sanofi-Synthelabo S.A - SPAIN


Pentaxim,Suspension

Tetanus Toxoid Ph Eur


Diphtheria Toxoid Ph Eur
Bordatella Pertussis
Antigens Ph Eur

Registrant

Manufacturer

Purified Hepatitis B surface 20 mcg/ml


antigen(HBsAg) IH

Purified Hepatitis B surface 20 mcg/ml


antigen(HBsAg) IH

2,955 TAN 05,688 J07A SHA

Shelf life
month

40 IU
30 IU
50 IU

Schering Plough (Pty) Ltd - SOUTH AFRICA

Page 468 of 584

Human Medicinal Products


S/No:

Registration Number

2,957 TAN 00,854 H02B S-P

Product Name
Pack and Pack size

Ingredient(s) and Strength

3 mg/ml
4 mg/ml

4 mg/ml

Garasone,Ophthalmic
Solution

Betamethasone Sodium
1.316 mg/ml
Phosphate Ph Eur
Gentamicin Sulphate
3 mg/ml
equivalent to Gentamicin Ph
Eur

2,960 TAN 07,575 D07A SCH

2,962 TAN 00,843 D06A S-P

Schering Plough
Laboratories N.V
BELGIUM

24

24

Schering Plough
Laboratories N.V
BELGIUM

Schering Plough
Laboratories N.V
BELGIUM

Diprosone,Ointment
Schering Plough
Laboratories N.V
BELGIUM

0.64 mg/g

48

Gentamicin Sulphate
equivalent to Gentamicin
USP

1 %w/w

36

Schering Plough Canada


CANADA

Gentamycin Sulphate
equivalent to Gemtamicin
USP

1 %w/w

36

S-P Canada
CANADA

Betamethasone
Dipropionate Ph Eur

2,961 TAN 00,842 D06A S-P

24

Celestone,Injectable Solution

Betamethasone Disodium
Phosphate Ph Eur

2,959 TAN 00,1502 S03C S-P

Manufacturer

Celestone,Injectable Solution

Betamethasone Acetate Ph
Eur
Betamethasone Sodium
Phosphate Ph Eur
2,958 TAN 00,855 H02A S-P

Shelf life
month

Garamycin,Ointment

Garamycin,Cream

Page 469 of 584

Human Medicinal Products


S/No:

Registration Number

2,963 TAN 00,844 D07A S-P

2,964 TAN 00,863 D04A S-P

2,965 TAN 00,845 D07A S-P

2,966 TAN 00,846 D07A S-P

Product Name
Pack and Pack size

Ingredient(s) and Strength

1 %w/w

24

Loratadine IH

10 mg/ml

36

Mometasone Furoate IH

1 %w/w

24

S-P Canada
CANADA

1 %w/w

24

S-P Canada
CANADA

0.5 mg/g

36

Schering Plough Canada


CANADA

Claritine,Syrup
Schering Plough
Laboratories N.V
BELGIUM

Elocom,Lotion

Elocom H,Ointment

Diprosalic,Ointment

30 mg/g

Clarinase Repetabs,Tablet

Loratadine IH
Pseudoephedrine Sulphate
USP

Registrant

S-P Canada
CANADA

Mometasone Furoate Ph
Eur

Betamethasone
Dipropionate Ph Eur
Salicylic Acid Ph Eur
2,968 TAN 00,1503 R05E S-P

Manufacturer

Elocom,Cream

Mometasone Furoate IH

2,967 TAN 00,1228 D07X S-P

Shelf life
month

50 mg
5 mg

Schering Plough Animal Health Coporation - USA

Page 470 of 584

24

Schering Plough
Laboratories N.V
BELGIUM

Human Medicinal Products


S/No:

Registration Number

2,969 TAN 00,2277 G03X SCH

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,970 TAN 00,1228 D07C S-P

2,971 TAN 00,2556 R06A ESS

Registrant
2,972 TAN 00,856 J01K S-P

2,973 TAN 00,858 D07X S-P

2,974 TAN 00,859 D07A S-P

Manufacturer

Estrumate,Injectable Solution
263 mcg/ml

36

Eagle multrade ltd


TANZANIA

Gentamicin Sulphate
equivalent to Gentamicin
USP
Betamethasone Valerate
USP

1 mg/g

24

Schering Plough Canada


CANADA

Desloratadine Ph Eur

0.5 mg

Cloprostenol Sodium BP

Registrant

Shelf life
month

Schering Plough Canada - CANADA


Celestoderm with
Garamycin,Cream

1 mg/g

Aerius,Syrup
24

Schering Plough
Laboratories N.V
BELGIUM

Schering Plough Laboratories N.V - BELGIUM


Garamycin,Ophthalmic
Solution

Gentamycin Sulphate USP

3 mg/ml

60

Betamethasone
Dipropionate Ph Eur
Clotrimazole Ph Eur

0.64 mg/g

48

Betamethasone
Dipropionate Ph Eur

0.64 mg/g

Schering Plough
Laboratories N.V
BELGIUM

Lotriderm,Cream

10 mg/g

Schering Plough
Laboratories N.V
BELGIUM

Diprosone,Cream

Page 471 of 584

60

Schering Plough
Laboratories N.V
BELGIUM

Human Medicinal Products


S/No:

Registration Number

2,975 TAN 00,860 R06A S-P

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,976 TAN 09,072 L01X SCH

Peg-intron,Powder for
Injection

Peg-intron,Powder for
Injection

PEG - Interferon alfa 2b


USP

2,979 TAN 09,075 V07A SCH

Peg-intron,Powder for
Injection

PEG - Interferon alfa 2b IH

2,980 TAN 09,067 V07A SCH

60

Schering-Plough (Pty Ltd.


SOUTH AFRICA

Temodal,Capsules

PEG - Interferon alfa 2b IH

2,978 TAN 09,066 V07A SCH

0.4 mg/ml

Schering-Plough (Pty Ltd. - SOUTH AFRICA


Temozolomide IH

2,977 TAN 09,065 V07A SCH

Manufacturer

Polaramine,Syrup

Dexchlorpheniramine
Maleate USP

Registrant

Shelf life
month

Peg-intron,Powder for
Injection

PEG - Interferon alfa 2b IH

Page 472 of 584

Schering Plough
Laboratories N.V
BELGIUM

20 mg

24

50 mcg

36

80 mcg

36

120 mcg

36

Schering Plough
REPUBLIC OF IRELAND

150 mcg

36

Schering Plough
REPUBLIC OF IRELAND

Schering Plough
REPUBLIC OF IRELAND

Schering Plough (Brinny)


Co.
REPUBLIC OF IRELAND

Human Medicinal Products


S/No:

Registration Number

2,981 TAN 09,064 V07A SCH

2,982 TAN 09,071 L01X SCH

2,983 TAN 09,073 L01X SCH

2,984 TAN 09,074 L01X SCH

Registrant
2,985 TAN 00,866 J01H SED

2,986 TAN 00,872 M01A SED

Product Name
Pack and Pack size

Ingredient(s) and Strength

Peg-intron,Powder for
Injection

Shelf life
month

Manufacturer

PEG - Interferon alfa 2b IH

100 mcg

36

Schering Plough
REPUBLIC OF IRELAND

Temozolomide IH

180 mg

24

Schering Plough Labo. N.V


BELGIUM

Temozolomide IH

100 mg/ml

24

Schering Plough Labo. N.V


BELGIUM

Temozolomide IH

250 mg

24

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP
250 mg
Flucloxacillin Sodium BP
2007

36

Sedico Pharmaceutical Co
EGYPT

Diclofenac Sodium BP

48

Sedico Pharmaceutical Co
EGYPT

Temodal,Capsules

Temodal,Capsules

Temodal,Capsules
Schering Plough
Laboratories N.V
BELGIUM

Sedico Pharmaceutical Co - EGYPT


Flucamox,Capsules

Rheumarene,Tablet

Page 473 of 584

50 mg

Human Medicinal Products


S/No:

Registration Number

2,987 TAN 00,873 A02B SED

Product Name
Pack and Pack size

Ingredient(s) and Strength

2,988 TAN 06,104 D07C SEO

2,989 TAN 06,107 J02A SEO

2,990 TAN 06,106 M01A SEO

2,991 TAN 06,105 N02B SEO

2,992 TAN 06,209 J05B SEO

Manufacturer

Omepak,Capsules
20 mg

36

Sedico Pharmaceutical Co
EGYPT

Nystatin IH
Neomycin Sulphate IH
Clobetasol Propionate USP

100,000 IU/g
5 mg/g
0.5 mg/g

36

Seoul Pharma.Co.Ltd.
KOREA

Fluconazole USP

150 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Diclofenac Sodium IH

10 mg/g

36

Seoul Pharma.Co.Ltd.
KOREA

Paracetamol IH

650 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Thymomodulin IH

80 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Omeprazole IH

Registrant

Shelf life
month

Seoul Pharma.Co.Ltd. - KOREA


Keserasin,Cream

Diflu 150,Capsules

Sting,Gel

Timerol,Tablet

Vitro,Capsules

Page 474 of 584

Human Medicinal Products


S/No:

Registration Number

2,993 TAN 06,208 A05B SEO

2,994 TAN 06,206 A04A SEO

2,995 TAN 06,207 D01B SEO

2,996 TAN 00,874 D07C SEO

Registrant
2,997 TAN 00,4164 J05A SEO

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Evitan,Capsules

L-Ornithine L-aspartate IH
Tocopheryl Acetate IH
Allium Sativum IH

80 mg
50 mg
1000 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Domperidone Maleate NA

10 mg

24

Seoul Pharma.Co.Ltd.
KOREA

Terbinafine Hydrochloride
IH

10 mg

24

Seoul Pharma.Co.Ltd.
KOREA

Triamcinolone Acetonide
USP
Econazole Nitrate USP
Gentamicin Sulphate USP

10 %w/w

24

Seoul Pharma.Co.Ltd.
KOREA

36

Seoul Pharma.Co.Ltd.
KOREA

Ompel-M,Tablet

Binafin,Cream

Safi,Cream

1 %w/w
1 %w/w

Seoul Pharmaceutical Co. Ltd - KOREA


Acyrovin,Cream

Acyclovir IH

2,998 TAN 00,4162 A11E SEO

Shelf life
month

Hirmen,Capsules

Page 475 of 584

50 mg/g

Human Medicinal Products


S/No:

Registration Number

2,999 TAN 00,4411 G03C SEO

3,000 TAN 00,4412 C06A SEO

3,001 TAN 00,4413 J02A SEO

3,002 TAN 00,4627 R06A SEO

3,003 TAN 05,681 M01A SEO

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

30 mg
Inositol IH
15 mg
Calcium Pantothenate IH
50 mg
Fursultiamine IH
30 mcg
Cyanocobalamine IH
Riboflavine Tetrabutyrate IH 6 mg
5 mg
Gamma Orizanol IH
Sodium Chondroitin
90 mg
Sulphate IH
50 mg
Nicotinamide IH
Pyridoxine Hydrochloride
25 mg
Ascorbic Acid IH

36

Seoul Pharma.Co.Ltd.
KOREA

Clomiphene Citrate USP

50 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Atenolol Ph Eur

50 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Ketoconazole USP

200 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Chlorpheniramine Maleate
IH
Betamethasone USP

2 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Nimesulide IH

100 mg

Clomicite,Tablet

Rozamin,Tablet

Ketocoze,Tablet

Bedamin,Tablet

0.25 mg

Nipenta,Tablet

Page 476 of 584

36

Centaur Drug House Pvt


Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

3,004 TAN 05,681 M01A SEO

3,005 TAN 00,875 D07C SEO

3,006 TAN 00,4164 J05A SEO

3,007 TAN 00,4164 J05A SEO

3,008 TAN 00,4163 D04A SEO

3,009 TAN 00,4163 D04A SEO

3,010 TAN 00,4413 J02A SEO

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Nipenta,Tablet
Centaur Drug House Pvt
Ltd
INDIA

Nimesulide IH

100 mg

36

Betamethasone
Dipropionate USP
Clotrimazole USP
Gentamycin Sulphate USP

0.64 mg

36

Acyclovir IH

50 mg/g

36

Seoul Pharma.Co.Ltd.
KOREA

Acyclovir IH

50 mg/g

36

Seoul Pharma.Co.Ltd.
KOREA

Cetrizine Dihydrochloride
BP

10 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Cetrizine Dihydrochloride
BP

10 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Ketoconazole USP

200 mg

36

Seoul Pharma.Co.Ltd.
KOREA

Gentriderm,Cream

10 mg
1 mg

Seoul Pharmaceutical Co.


Ltd
KOREA

Acyrovin,Cream

Acyrovin,Cream

Terizin,Tablet

Terizin,Tablet

Ketocoze,Tablet

Page 477 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
3,011 TAN 00,4165 L01A SER

Product Name
Pack and Pack size

Ingredient(s) and Strength

Carboplatin,Lyophilized
Injection

150 mg

24

Serum Institute of India


INDIA

1500 IU/ml

24

Serum Institute of India


INDIA

Carboplatin USP

150 mg

24

Serum Institute of India


INDIA

BCG BP

0.1 ml/10 doses

24

Serum Institute of India


INDIA

> 2.5 IU IU

24

Serum Institute of India


INDIA

40 IU/0.5ml

24

Serum Institute of India


INDIA

SII Tetanus
Antitoxin,Injectable Solution

Tetanus Antitoxin BP

3,013 TAN 00,4165 L01A SER

3,014 TAN 00,4330 J07A SER

3,015 TAN 05,053 J07A SER

Carboplatin,Injectable
Solution

BCG,Solution

SII Rabivax,Injectable
suspension

Rabies Virus Antigen USP

3,016 TAN 05,685 J07A SER

Manufacturer

Serum Institute of India - INDIA


Carboplatin USP

3,012 TAN 00,2640 J06B SER

Shelf life
month

SII Tetanus Toxoid


Adsorbed,Injectable Solution

Tetanus Toxoid IH

Page 478 of 584

Human Medicinal Products


S/No:

Registration Number

3,017 TAN 05,684 J07A SER

Product Name
Pack and Pack size

Ingredient(s) and Strength

Vincristine,Injectable
Solution

Vincristine Sulphate BP

3,021 TAN 00,2640 J06B SER

SII Tetanus
Antitoxin,Injectable Solution

Tetanus Antitoxin BP

3,022 TAN 00,2404 L01A SER

Serum Institute of India


INDIA

10 mcg/ml

24

Serum Institute of India


INDIA

10 mcg/ml

24

Serum Institute of India


INDIA

1g

24

Serum Institute of India


INDIA

1500 IU/ml

24

Serum Institute of India


INDIA

1 mg/ml

24

Serum Institute of India


INDIA

1 mg/ml

24

Serum Institute of India


INDIA

Cisplatin,Injectable Solution

Cisplatin BP

3,023 TAN 00,2405 L01A SER

24

Hepatitis B,Suspension

Hepatitis B Vaccine BP

3,020 TAN 06,442 L01C SER

20 mcg/ml

Hepatitis B,Suspension

Hepatitis B Vaccine BP

3,019 TAN 05,682 J07A SER

Manufacturer

Hepatitis B,Suspension

Hepatitis B Vaccine BP

3,018 TAN 05,683 J07A SER

Shelf life
month

Cisplatin,Injectable Solution

Cisplatin BP

Page 479 of 584

Human Medicinal Products


S/No:

Registration Number

3,024 TAN 09,206 J01D SER

Product Name
Pack and Pack size

Ingredient(s) and Strength

S11 Polyvalent Anti-Snake


Venom Serum,Injectable
Black Mamba IH
Solution

Gaboon viper IH
Resells viper IH
Saw - scaled viper IH

3,025 TAN 05,053 J07A SER

SII Tetanus Toxoid


Adsorbed,Injectable Solution

Tetanus Toxoid IH

3,027 TAN 05,684 J07A SER

3,029 TAN 07,231 J01H SHA

Serum Institute of India


INDIA

>2.5 IU

24

Serum Institute of India


INDIA

40 IU/0.5ml

24

Serum Institute of India


INDIA

20 mcg/ml

24

Serum Institute of India


INDIA

10 mcg/ml

24

Serum Institute of India


INDIA

Shandong Reyoung Pharm.Co.Ltd - CHINA


Benzathine Penicillin,Powder
for Injection

Benzathine Penicillin BP

Registrant

48

Hepatitis B,Suspension

Hepatitis B Vaccine BP

Registrant

0.45 mg
0.6 mg
0.6 mg
0.45 mg

Hepatitis B,Suspension

Hepatitis B Vaccine BP

3,028 TAN 05,682 J07A SER

Manufacturer

SII Rabivax,Vaccine

Rabies Virus Antigen USP

3,026 TAN 05,685 J07A SER

Shelf life
month

2.4 Mega units

Shanghai Pharma Industrial Co. Ltd - CHINA

Page 480 of 584

24

Shandong Reyoung
Pharm.Co.Ltd
CHINA

Human Medicinal Products


S/No:

Registration Number

3,030 TAN 07,228 M01A SHA

3,031 TAN 07,230 N02B SHA

3,032 TAN 07,229 J01A SHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Indomethacin BP

250 mg

36

Paracetamol BP

500 mg

36

250 mg

36

400 mg
80 mg

36

Doxycycline Hyclate USP

100 mg

24

3,035 TAN 09,209 P02A SHA

Praziquantel USP

600 mg

36

3,036 TAN 09,292 J02A SHA

200 mg

36

Zhejiang Holley Nanhu


Pharmaceutical Co. Ltd
CHINA

Paracetamol,Tablet
Zhejiang Holley Nanhu
Pharmaceutical Co. Ltd
CHINA

Tetracycline,Capsules
Zhejiang Holley Nanhu
Pharmaceutical Co. Ltd
CHINA

Co-trimoxazole,Tablet

Sulfamethoxazole BP
Trimethoprim BP

3,034 TAN 09,208 J01A SHA

Manufacturer

Indomethacin,Capsules

Tetracycline Hydrochloride
BP

3,033 TAN 09,207 J03B SHA

Shelf life
month

Zhejiang Holley Nanhu


Pharmaceutical Co. Ltd
CHINA

Doxycycline Hyclate,Capsules
Zhejiang Holley Nanhu
Pharmaceutical Co. Ltd
CHINA

Praziquantel,Tablet
Zhejiang Holley Nanhu
Pharmaceutical Co. Ltd
CHINA

Ketoconazole,Tablet

Ketoconazole USP

Page 481 of 584

Zhejiang Holley Nanhu


Pharmaceutical Co. Ltd
CHINA

Human Medicinal Products


S/No:

Registration Number

3,037 TZ11H016

3,038 TZ11H017

Registrant
3,039 TAN 00,4574 N02B SHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,041 TAN 00,4628 R03A SHA

3,042 TAN 00,4575 R05C SHA

Manufacturer

Amocin,Capsules

Ampicillin Sodium eq to
Ampicillin BP

125 mg/5ml

36

Ampicillin Sodium eq to
Ampicillin BP

125 mg/5ml

36

Zhejiang Holley Nanhu


Pharmaceutical Co. Ltd
CHINA

Amocin,Capsules
Zhejiang Holley Nanhu
Pharmaceutical Co. Ltd
CHINA

Shaphaco Pharmaceutical Industries - REP. OF YEMEN


Amol,Syrup

Paracetamol BP

3,040 TAN 00,4573 J01H SHA

Shelf life
month

120 mg/5ml

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Shamoxil,Capsules

Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin BP

36

Salbutamol Sulphate eq
Salbutamol BP

2 mg/5ml

24

Dextromethorphan
Hydrobromide BP
Guaiphenesin BP
Pseudoephedrine
Hydrochloride BP

15 mg/5ml

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Salbutin,Syrup
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Kafid,Syrup

Page 482 of 584

100 mg/5ml
30 mg/5ml

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Human Medicinal Products


S/No:

Registration Number

3,043 TAN 00,4576 J01H SHA

3,044 TAN 00,4574 N02B SHA

3,045 TAN 05,202 N02B SHA

3,046 TAN 05,204 J01K SHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,048 TAN 05,201 R06A SHA

3,049 TAN 05,692 D06A SHA

Manufacturer

Penpiclox,Dry Syrup

Cloxacillin Sodium
125 mg
equivalent to Cloxacillin BP
Ampicillin Trihydrate
125 mg
equivalent to Ampicillin BP

36

Paracetamol BP

120 mg/5ml

36

Paracetamol BP

250 mg/100ml

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Amol,Syrup
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Amol 6 Plus,Syrup
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Ciprox,Tablet

Ciprofloxacin Hydrochloride 500 mg


BP

3,047 TAN 05,203 P01A SHA

Shelf life
month

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Sharizole,Suspension

Metronidazole BP

200 mg/5ml

36

Chlorpheniramine BP

4 mg

36

Sodium Fusidate BP

0.3 g

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Histavil,Tablet
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Fucide,Ointment

Page 483 of 584

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Human Medicinal Products


S/No:

Registration Number

3,050 TAN 05,693 R05C SHA

3,051 TAN 05,694 C04A SHA

3,052 TAN 05,695 J01C SHA

3,053 TAN 05,690 R06A SHA

3,054 TAN 05,691 A03B SHA

3,055 TAN 07,232 C04A SHA

3,056 TAN 07,233 J01C SHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Shabynil,Syrup

Ammonium Chloride BP
Diphenyhydramine
Hydrochloride BP

135 mg/5ml
14 mg/5ml

36

Sildenafil Citrate IH

50 mg

24

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Zwagra,Tablet
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Penpiclox,Capsules

Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP
Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP

36

Chlorpheniramine Maleate
BP

2 mg/5ml

36

Homatropine methyl
Bromide USP

2 mg/ml

36

Tadalafil IH

20 mg

24

Clavulanic Acid USP


Amoxicillin Trihydrate USP

125 mg
500 mg

24

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Histavil,Syrup
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Spasmo,Solution
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Saheal,Tablet
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Augmoks,Tablet

Page 484 of 584

Global Pharma.Co. LLC


UNITED ARAB EMIRATES

Human Medicinal Products


S/No:

Registration Number

3,057 TAN 07,234 J01C SHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,059 TAN 09,210 N02B SHA

3,060 TAN 00,4575 R05C SHA

3,061 TAN 00,4576 J01H SHA

3,062 TAN 05,202 N02B SHA

Manufacturer

Augmoks,Syrup

Clavulanic Acid USP


Amoxicillin Trihydrate
equivalent to Amoxicillin
USP
3,058 TAN 00,4573 J01H SHA

Shelf life
month

31.25 mg/5ml
125 mg/5ml

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Shamoxil,Capsules

Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin BP

36

Caffeine Anhydrous BP
Paracetamol BP

65 mg
500 mg

36

Dextromethorphan
Hydrobromide BP
Guaiphenesin BP
Pseudoephedrine
Hydrochloride BP

15 mg/5ml

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Amol Extra,Tablet
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Kafid,Syrup

100 mg/5ml
30 mg/5ml

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Penpiclox,Dry Syrup

Cloxacillin Sodium
125 mg
equivalent to Cloxacillin BP
Ampicillin Trihydrate
125 mg
equivalent to Ampicillin BP

36

Paracetamol BP

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Amol 6 Plus,Syrup

Page 485 of 584

250 mg/100ml

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Human Medicinal Products


S/No:

Registration Number

3,063 TAN 05,204 J01K SHA

3,064 TAN 05,204 J01K SHA

3,065 TAN 05,203 P01A SHA

3,066 TAN 05,201 R06A SHA

3,067 TAN 05,692 D06A SHA

3,068 TAN 05,693 R05C SHA

3,069 TAN 05,694 C04A SHA

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Ciprox,Tablet

Ciprofloxacin Hydrochloride 500 mg


BP

36

Ciprofloxacin Hydrochloride 500 mg


BP

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Ciprox,Tablet
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Sharizole,Suspension

Metronidazole BP

200 mg/5ml

36

Chlorpheniramine BP

4 mg

36

Sodium Fusidate BP

0.3 g

36

Ammonium Chloride BP
Diphenyhydramine
Hydrochloride BP

135 mg/5ml
14 mg/5ml

36

Sildenafil Citrate IH

50 mg

24

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Histavil,Tablet
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Fucide,Ointment
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Shabynil,Syrup
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Zwagra,Tablet

Page 486 of 584

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Human Medicinal Products


S/No:

Registration Number

3,070 TAN 05,695 J01C SHA

3,071 TAN 05,690 R06A SHA

3,072 TAN 05,691 A03B SHA

Registrant
3,073 TZ11H049

3,074 TZ11H050

3,075 TZ11H052

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Penpiclox,Capsules

Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP
Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP

36

Chlorpheniramine Maleate
BP

2 mg/5ml

36

Homatropine methyl
Bromide USP

2 mg/ml

36

Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Histavil,Syrup
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Spasmo,Solution
Shaphaco Pharmaceutical
Industries
REP. OF YEMEN

Shelys Pharmaceuticals Ltd. - TANZANIA


Sulphadar,Tablet

Pyrimethamine BP
Sulfadoxine BP

25 mg
500 mg

36

Mebendazole BP

100 mg

36

Sulfamethoxazole BP
Trimethoprim IH

400 mg
80 mg

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

Meben,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Shetrim,Tablet

Page 487 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,076 TZ11H143

3,077 TZ11H049

3,078 TZ11H047

3,079 TZ11H058

3,080 TZ11H040

3,081 TZ11H041

3,082 TZ11H042

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Fluzol,Tablet

Fluconazole BP

200 mg

24

Pyrimethamine BP
Sulfadoxine BP

25 mg
500 mg

36

Prazinquatel USP

600 mg

48

Phenoxymethyl Penicillin BP 250 mg

24

Chlorpheniramine Maleate
BP
Paracetamol BP
Pseudoephedrine BP

1 mg/5ml

36

Paracetamol BP

500 mg

48

310 mg

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

Sulphadar,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Praziquantel,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Pen V,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Coldril,Syrup

120 mg/5ml
10 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

Sheladol,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Quinine Sulphate,Tablet

Quinine Sulphate BP

Page 488 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,083 TZ11H043

3,084 TZ11H044

3,085 TZ11H045

3,086 TZ11H046

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,088 TZ11H051

3,089 TZ11H053

Manufacturer

Tetrashel,Capsules

Tetracycline Hydrochloride
BP

250 mg

36

Sulfadimidine BP

500 mg

48

Folic Acid BP

0.5 mg

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

Sulphadim,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Folic Acid,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Erythromin,Tablet

Erythromycin Estolate USP 250 mg

3,087 TZ11H048

Shelf life
month

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

Chloramphenicol,Capsules

Chloramphenicol BP

250 mg

36

Chlorpheniramine Maleate
BP

4 mg

48

Acetylsalicylic Acid BP

300 mg

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

Histin,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Aspirin,Tablet

Page 489 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,090 TZ11H054

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,092 TZ11H057

3,093 TZ11H059

3,094 TZ11H060

3,096 TZ11H062

2 mg/5ml

48

40 mg/5ml
100 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

Cloxam,Capsules

Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

60

Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg

24

Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Ampishel,Capsules
Shelys Pharmaceuticals
Ltd.
TANZANIA

Cloxashel,Capsules
Shelys Pharmaceuticals
Ltd.
TANZANIA

Sulphadar,Suspension

Pyrimethamine BP
Sulfadoxine BP

3,095 TZ11H061

Manufacturer

Koflyn,Syrup

Chlorpheniramine Maleate
IH
Sodium Citrate IH
Ammonium Chloride IH
3,091 TZ11H056

Shelf life
month

12.5 mg/5ml
250 mg/5ml

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Amolin,Capsules

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

48

Ampicillin Trihydrate
equivalent to Ampicillin BP

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Ampishel,Syrup

Page 490 of 584

125 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,097 TZ11H063

3,098 TZ11H064

3,099 TZ11H065

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,101 TZ11H067

3,102 TZ11H068

Manufacturer

Amolin,Syrup

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

60

Pyridoxine Hydrochloride
Ascorbic Acid BP
Folic Acid BP
Zinc Sulphate BP
Ferric Ammonium Citrate
BP
Cyanocobalamine BP

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Hemovit,Syrup
0.5 mg/5ml
1.5 mg/5ml
2.3 mg/5ml
200 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

5 mcg/5ml

Erythromycin,Syrup
125 mg/5ml

24

Phenoxymethylpenicillin
125 mg/5ml
Potassium equivalent to
Phenoxymethylpenicillin BP

24

Ampicillin Trihydrate
125 mg/5ml
equivalent to Ampicillin BP
Cloxacillin Sodium
125 mg/5ml
equivalent to Cloxacillin BP

24

Cloxacillin Sodium
125 mg/5ml
equivalent to Cloxacillin BP

36

Erythromycin Estolate BP

3,100 TZ11H066

Shelf life
month

Shelys Pharmaceuticals
Ltd.
TANZANIA

Pen V,Syrup
Shelys Pharmaceuticals
Ltd.
TANZANIA

Cloxam,Syrup
Shelys Pharmaceuticals
Ltd.
TANZANIA

Cloxashel,Powder

Page 491 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,103 TZ11H069

3,104 TZ11H070

3,105 TZ11H071

3,106 TZ11H072

3,107 TZ11H073

3,108 TZ11H074

3,109 TZ11H075

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Gastrocid,Suspension
25 mg/5ml
Simethicone IH
Magnesium Hydroxide USP 195 mg/5ml
Aluminium Hydroxide USP 220 mg/5ml

36

Salbutamol Sulphate
2 mg/5ml
equivalent to Salbutamol BP

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Asthalin,Syrup
Shelys Pharmaceuticals
Ltd.
TANZANIA

Amodar,Suspension

Amodiaquine BP

200 mg/5ml

24

Paracetamol BP
Diclofenac BP

500 mg
50 mg

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Diclopar,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Muco Asthalin,Syrup

Bromhexine Hydrochloride 4 mg/5ml


BP
Salbutamol Sulphate
2 mg/5ml
equivalent to Salbutamol BP

24

Chlorpheniramine Maleate
BP
Paracetamol BP

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Coldril,Capsules
2 mg
500 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

Amodar,Tablet

Amodiaquine Hydrochloride 260 mg


BP

Page 492 of 584

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,110 TZ11H076

3,111 TZ11H077

3,112 TZ11H078

Product Name
Pack and Pack size

Ingredient(s) and Strength

Bendrofluazide BP

5 mg

24

Aluminium Hydroxide wet


gel equivalent to dried
Aluminium Hydroxide gel
BP
Magnesium Trisilicate BP

300 mg

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

250 mg

Phenobarbitone,Tablet
30 mg

24

300 mg
75 mg
0.76 mg
5 mg
0.005 mg

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Hematone,Capsules
Shelys Pharmaceuticals
Ltd.
TANZANIA

Bromoxil,Syrup

Bromhexine Hydrochloride 4 mg/5ml


BP
Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP
3,115 TZ11H082

Shelys Pharmaceuticals
Ltd.
TANZANIA

Shelatal,Tablet

Ferrous Fumarate BP
Ascorbic Acid BP
Folic Acid BP
Zinc Sulphate BP
Cyanocobalamin BP
3,114 TZ11H080

Manufacturer

Bendrofluazide,Tablet

Phenobarbitone BP

3,113 TZ11H079

Shelf life
month

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Gripe Water,Solution

Dill Oil BP
Sodium Bicarbonate BP

Page 493 of 584

0.01 mg/5ml
40 mg/5ml

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,116 TZ11H083

3,117 TZ11H084

3,118 TZ11H085

3,119 TZ11H086

3,120 TZ11H087

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Mucolyn,Syrup
24

Bromhexine Hydrochloride
BP
Chlorpheniramine Maleate
BP
Dextromethorphan
Hydrobromide BP
Ammonium Chloride Ph Eur

4 mg/5ml

Ibuprofen BP

200 mg

36

Albendazole USP

200 mg/5ml

36

Acetylsalicylic Acid BP

300 mg

24

120 mg/5ml

24

2 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

5 mg/50ml
50 mg/5ml

Ibuprofen,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Alben,Suspension
Shelys Pharmaceuticals
Ltd.
TANZANIA

Aspirin,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Sheladol,Suspension

Paracetamol BP

3,121 TZ11H088

Shelf life
month

Megavit,Syrup

Page 494 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,122 TZ11H089

3,123 TZ11H090

Product Name
Pack and Pack size

Ingredient(s) and Strength

Pyridoxine Hydrochloride
Ascorbic Acid BP
Niacinamide BP
Thiamine Hydrochloride BP
Ascorbic Acid BP
Cyanocobalamine BP
Riboflavine BP
Cholecalciferol BP
D-Panthenol BP
Vitamin A Palmitate BP

2 mg/5ml

Quinine Bisulphate
equivalent to Quinine BP

50 mg/5ml

3,125 TZ11H093

3,126 TZ11H094

24

20 mg/5ml
3 mg/5ml
10 mg/5ml
5 mcg/5ml
0.856 mg/5ml
400 IU/5ml
5 mg/5ml
5000 IU/5ml

Manufacturer
Shelys Pharmaceuticals
Ltd.
TANZANIA

Quinalin,Syrup
24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Hyoscine,Tablet

Hyoscine Butylbromide 23.8 10 mg

3,124 TZ11H092

Shelf life
month

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Shetrim,Suspension

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

36

Sulfamethopyrazine BP
Pyrimethamine BP

500 mg
25 mg

36

Levamisole Hydrochloride
BP

47 mg

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Malafin,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Shetrax,Syrup

Page 495 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,127 TZ11H095

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,130 TZ11H098

3,131 TZ11H099

3,132 TZ11H100

3,133 TZ11H101

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Ketoconazole,Tablet
200 mg

24

Ciprofloxacin Hydrochloride 500 mg


BP

24

Diclofenac Sodium BP

50 mg

36

Promethazine Hydrochloride 25 mg
BP

36

Albendazole BP

200 mg

48

250 mg

36

Ketoconazole USP

3,129 TZ11H097

Manufacturer

Doxycycline,Capsules

Doxycycline Hyclate Ph Eur 100 mg

3,128 TZ11H096

Shelf life
month

Shelys Pharmaceuticals
Ltd.
TANZANIA

Ciprone,Caplets
Shelys Pharmaceuticals
Ltd.
TANZANIA

Diclofenac,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Promethazine,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Alben,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Azithromycin,Tablet

Azithromycin USP

Page 496 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,134 TZ11H102

3,135 TZ11H103

3,136 TZ11H104

3,137 TZ11H105

3,138 TZ11H106

3,139 TZ11H107

3,140 TZ11H108

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Domperidone,Solution

Domperidone Maleate BP

5 mg/5ml

24

Griseofulvin BP

500 mg

24

Clotrimazole BP

1 %w/w

24

Omeprazole BP

20 mg

24

Paracetamol BP

120 mg

24

Aluminium Hdroxide Gel


equivalent to Aluminium
Hydroxide BP
Peppermint oil BP
Magnesium Trisilicate BP

120 mg

24

Paracetamol BP
Pseudoephedrine
Hydrochloride BP

500 mg
30 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

Griseofulvin,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Clotrimazole,Powder
Shelys Pharmaceuticals
Ltd.
TANZANIA

Sompraz,Capsules
Shelys Pharmaceuticals
Ltd.
TANZANIA

Sheladol,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Gastrocid,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

0.003 ml
250 mg

Coldril,Tablet

Page 497 of 584

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,141 TZ11H109

3,142 TZ11H110

3,143 TZ11H111

3,144 TZ11H112

3,145 TZ11H113

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Megavit,Syrup
36

Niacinamide BP
Cholecalciferol BP
D-Panthenol BP
Vitamin A Palmitate BP
Cyanocobalamine BP
Riboflavine BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Hydrochloride BP

5 mg/5ml
400 IU/5ml
5 mg/5ml
5000 IU/5ml
5 mg/5ml
0.856 mg/5ml
2 mg/5ml

Ferric Ammonium Citrate


BP
Zinc Sulphate BP
Folic Acid BP
Cyanocobalamine BP
Pyridoxine Hydrochloride
Ascorbic Acid BP

200 mg

Dextromethorphan
Hydrobromide BP
Pseudoephedrine
Hydrobromide BP
Bromhexine Hydrochloride
BP
Ammonium Chloride BP

5 mg/5ml

Metronidazole BP

250 mg

48

Ampicillin Trihydrate
equivalent to Ampicillin BP

500 mg

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

3 mg/5ml

Hematone,Syrup
18

2.3 mg
1.5 mg
0.05 mg
0.5 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

Mucolyn,Syrup
36

30 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

4 mg/5ml
50 mg/5ml

Shelgyl,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Ampishel,Capsules

Page 498 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,146 TZ11H114

3,147 TZ11H115

3,148 TZ11H116

3,149 TZ11H117

Product Name
Pack and Pack size

Ingredient(s) and Strength

Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin BP

48

Albendazole BP

400 mg/5ml

36

Sulfamethoxazole BP
Trimethoprim BP

800 mg
160 mg

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Shetrim,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Amolin,Dry Syrup
24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Phenobarbitone,Tablet

Oral Rehydration Salt,Powder


for Reconstitution

Glucose BP
Sodium Chloride BP
Potassium Chloride BP
Sodium Citrate Dihydrate
BP

3,152 TZ11H120

Shelys Pharmaceuticals
Ltd.
TANZANIA

Alben,Suspension

Phenobarbitone BP

3,151 TZ11H119

Manufacturer

Amolin,Capsules

Amoxicillin Trihydrate
250 mg/5ml
equivalent to Amoxicillin BP

3,150 TZ11H118

Shelf life
month

100 mg

48

20 g/100g
35 g/100g
1.5 g/100g
2.9 g/100g

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Shelys Pharmaceuticals
Ltd.
TANZANIA

Ciprofloxacin,Tablet

Ciprofloxacin Hydrochloride 250 mg


BP

Page 499 of 584

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,153 TZ11H121

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,156 TZ11H124

3,157 TZ11H125

2 mg/5ml

24

5 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

10 mg/5ml
50 mg/5ml

Chloramphenicol,Suspension
125 mg/5ml

24

Metronidazole Benzoate BP 320 mg/5ml

36

Pyridoxine BP
Zinc Sulphate BP
Ferric Ammonium Citrate
BP
Thiamine BP
Nicotinamide BP
Cyanocobalamin BP
Riboflavin BP

24

Chloramphenicol Palmitate
BP

3,155 TZ11H123

Manufacturer

mucolyn Paediatric,Syrup

Chlorpheniramine Maleate
BP
Dextromethorphan
Hydrobromide BP
Pseudoephedrine
Hydrochloride BP
Ammonium Chloride BP
3,154 TZ11H122

Shelf life
month

Shelys Pharmaceuticals
Ltd.
TANZANIA

Shelgyl,Suspension
Shelys Pharmaceuticals
Ltd.
TANZANIA

Feritone B,Syrup
0.8 mg
5 mg
200 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

0.7 mg
8 mg
0.7 mg
0.856 mg

Ascorbic Acid,Tablet

Ascorbic Acid BP

Page 500 of 584

100 mg

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,158 TZ11H126

3,159 TZ11H127

3,160 TZ11H128

3,161 TZ11H129

3,162 TZ11H130

3,163 TZ11H131

3,164 TZ11H132

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Adult cough,Syrup

Ammonium Chloride BP
Dextromethorphan
Hydrobromide BP

25 mg
10 mg

24

Liquorice Liquid Extract BP


Ammonium Bicarbonate BP
Morphine Sulphate BP
Ammonium Chloride BP

0.17 ml
100 mg
0.15 ml
150 mg

24

Levamisole Hydrochloride
BP

40 mg

24

Nitrofurantoin BP

100 mg

24

Benzoic Acid BP
Salicylic Acid BP

6%
3%

36

Benzyl benzoate BP

25 %w/v

48

25 %w/v

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Mes,Syrup
Shelys Pharmaceuticals
Ltd.
TANZANIA

Shetrax,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Nitrofun,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Shelyderm,Lotion
Shelys Pharmaceuticals
Ltd.
TANZANIA

B.B.E,Solution
Shelys Pharmaceuticals
Ltd.
TANZANIA

Liniment Alba,Emulsion

Turpentine Oil BP

Page 501 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,165 TZ11H133

Product Name
Pack and Pack size

Ingredient(s) and Strength

6 %w/w
3 %w/w

24

1 mg
10 mg

24

3,169 TZ11H137

3,170 A589

3,171 A589

Shelys Pharmaceuticals
Ltd.
TANZANIA

Salbutamol,Tablet

Salbutamol Sulphate
4 mg
equivalent to Salbutamol BP

3,168 TZ11H136

Shelys Pharmaceuticals
Ltd.
TANZANIA

Vitamin B Complex,Tablet

Riboflavine Phosphate BP
Nicotinamide BP

3,167 TZ11H135

Manufacturer

Shelyfungin,Ointment

Benzoic Acid BP
Salicylic Acid BP

3,166 TZ11H134

Shelf life
month

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Paediatric cough,Syrup

Dextromethorphan
Hydrobromide BP

5 mg/5ml

36

Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Mononitrate BP
Riboflavine BP
Nicotinamide BP

2 mg

36

Metronidazole BP

250

48

Metronidazole BP

250

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

Becoshel,Syrup

5 mg
2 mg
20 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

Shelgyl,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Shelgyl,Tablet

Page 502 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,172 TAN 08,110 S01D SHE

Product Name
Pack and Pack size

Ingredient(s) and Strength

20 mg

36

500 mg

24

Diclofenac Sodium BP
Paracetamol BP
Chlorzoxazone USP

50 mg
500 mg
250 mg

24

3,175 TAN 09,219 P01A SHE

Tinidazole BP

500 mg

24

3,176 TAN 09,214 P01B SHE

Amodiaquine Hydrochloride 153 mg


equivalent to Amodiaquine
USP
50 mg
Artesunate IP

24

3,177 TAN 09,222 J03C SHE

Norfloxacin BP
Tinidazole BP

600 mg
400 mg

24

3,178 TAN 09,218 M01A SHE

25 mg

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Quinine Sulphate,Tablet

Quinine Sulphate BP

3,174 TAN 09,220 M01A SHE

Manufacturer

Ped Zinc,Alluminiun Foil

Zinc (From Zinc Sulphate


Monohydrate) USP

3,173 TAN 09,221 P01B SHE

Shelf life
month

Shelys Pharmaceuticals
Ltd.
TANZANIA

Diclopar - MR,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Wormazole,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Maladar Kit,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Nor - T,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Diclofenac Sodium,Tablet

Diclofenac Sodium BP

Page 503 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,179 TAN 09,217 R06A SHE

3,180 TAN 09,215 C01K SHE

3,181 TAN 09,212 R03A SHE

3,182 TAN 09,213 N02B SHE

3,183 TAN 09,211 M01A SHE

3,184 TAN 09,223 P01B SHE

3,185 TZ11H065

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Sheltrizine,Tablet

Cetrizine Hydrochloride BP 10 mg

24

Methyldopa BP

250 mg

24

Aminophylline BP

100 mg

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Dopashel,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Shephyline,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Tramashel,Capsules

Tramadol Hydrochloride BP 50 mg

24

Aceclofenac BP

100 mg

24

Levofloxacin IH

500 mg

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Acefen,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Levoz,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Erythromycin,Syrup
24

Page 504 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,186 TZ11H065

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Erythromycin,Syrup
24

3,187 TZ11H119

3,188 TZ11H119

3,189 TZ11H040

3,190 TZ11H041

3,191 TZ11H042

Manufacturer

Oral Rehydration Salt,Powder


for Reconstitution

24

Oral Rehydration Salt,Powder


for Reconstitution

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Shelys Pharmaceuticals
Ltd.
TANZANIA

Shelys Pharmaceuticals
Ltd.
TANZANIA

Coldril,Syrup
36

Chlorpheniramine Maleate
BP
Paracetamol BP
Pseudoephedrine
Hydrobromide BP
Pseudoephedrine BP

1 mg/5ml

Paracetamol BP

500 mg

48

310 mg

48

120 mg/5ml
10 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

10 mg/5ml

Sheladol,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Quinine Sulphate,Tablet

Quinine Sulphate BP

Page 505 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,192 TZ11H046

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,194 TZ11H054

3,195 TZ11H059

3,196 TZ11H061

3,197 TZ11H063

3,198 TZ11H064

Manufacturer

Erythromin,Tablet

Eryrthromycin Stearate BP 430.0 mg


Erythromycin Estolate USP 250 mg

3,193 TZ11H048

Shelf life
month

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

Chloramphenicol,Capsules

Chloramphenicol BP

250 mg

36

Chlorpheniramine Maleate
IH
Sodium Citrate IH
Ammonium Chloride IH

2 mg/5ml

48

Shelys Pharmaceuticals
Ltd.
TANZANIA

Koflyn,Syrup

40 mg/5ml
100 mg/5ml

Shelys Pharmaceuticals
Ltd.
TANZANIA

Cloxashel,Capsules

Cloxacillin Sodium eq
250 mg
Cloxacillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

36

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

48

Amoxicillin Trihydrate eq to 125 mg/5ml


Amoxicillin BP
Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

60

Shelys Pharmaceuticals
Ltd.
TANZANIA

Amolin,Capsules
Shelys Pharmaceuticals
Ltd.
TANZANIA

Amolin,Syrup

Hemovit,Syrup

Page 506 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Folic Acid BP
Ferric Ammonium Citrate
BP
Cyanocobalamine BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Zinc Sulphate Heptahydrate
BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Zinc Sulphate BP
3,199 TZ11H070

3,200 TZ11H072

3,201 TZ11H073

3,202 TZ11H074

1.5 mg/5ml
200 mg/5ml

Shelf life
month
24

Manufacturer
Shelys Pharmaceuticals
Ltd.
TANZANIA

0.05 mcg/5ml
0.5 mg
2.33 mg
0.5 mg/5ml
2.3 mg/5ml

Asthalin,Syrup

Salbutamol Sulphate
2 mg/5ml
equivalent to Salbutamol BP

36

Paracetamol BP
Diclofenac BP

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Diclopar,Tablet
500 mg
50 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

Muco Asthalin,Syrup

Salbutamol Sulphate
2.4 mg/5ml
equivalent to Salbutamol BP
Bromhexine Hydrochloride 4 mg/5ml
BP
1.0 mg/5ml
Racementhol BP

24

Paracetamol BP
Chlorpheniramine Maleate
BP
Pseudoephedrine
Hydrobromide BP

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Coldril,Capsules

Page 507 of 584

500 mg
2 mg
30 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,203 TZ11H074

Product Name
Pack and Pack size

Ingredient(s) and Strength

500 mg
2 mg

3,206 TZ11H083

3,207 TZ11H086

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

30 mg

Bromoxil,Syrup

Amoxicillin Trihydrate eq to 144 mg/5ml


Amoxicillin BP
Bromhexine Hydrochloride 4 mg/5ml
BP
Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP
3,205 TZ11H082

Manufacturer

Coldril,Capsules

Paracetamol BP
Chlorpheniramine Maleate
BP
Pseudoephedrine
Hydrobromide BP
3,204 TZ11H080

Shelf life
month

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Gripe Water,Solution

Dill Oil BP
Sodium Bicarbonate BP

0.01 mg/5ml
40 mg/5ml

36

Ammonium Chloride BP
Dextromethorphan
Hydrobromide BP
Chlorpheniramine Maleate
BP
Bromhexine Hydrochloride
BP
Racementhol BP

50 mg/5ml
5 mg/50ml

24

Acetylsalicylic Acid BP

300 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

Mucolyn,Syrup
Shelys Pharmaceuticals
Ltd.
TANZANIA

2 mg/5ml
4 mg/5ml
3 mg/5ml

Aspirin,Tablet

Page 508 of 584

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,208 TZ11H101

3,209 TZ11H103

3,210 TZ11H109

3,211 TZ11H116

3,212 TZ11H117

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Azuma,Tablet
24

Azithromycin Dihydrate eq
to Azithromycin Ph Eur
Azithromycin USP

250 mg

Griseofulvin BP

500 mg

24

Niacinamide BP
Cholecalciferol BP
D-Panthenol BP
Vitamin A Palmitate BP
Cyanocobalamine BP
Riboflavine BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Hydrochloride BP

5 mg/5ml
400 IU/5ml
5 mg/5ml
5000 IU/5ml
5 mg/5ml
0.856 mg/5ml
2 mg/5ml

36

Sulfamethoxazole BP
Trimethoprim BP

800 mg
160 mg

250 mg

Shelys Pharmaceuticals
Ltd.
TANZANIA

Griseofulvin,Tablet
Shelys Pharmaceuticals
Ltd.
TANZANIA

Megavit,Syrup
Shelys Pharmaceuticals
Ltd.
TANZANIA

3 mg/5ml

Shetrim,Tablet
36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Amolin,Dry Syrup

Amoxicillin Trihydrate
250 mg/5ml
equivalent to Amoxicillin BP

3,213 TZ11H121

Shelf life
month

mucolyn Paediatric,Syrup

Page 509 of 584

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Chlorpheniramine Maleate
BP
Dextromethorphan
Hydrobromide BP
Pseudoephedrine
Hydrochloride BP
Ammonium Chloride BP
3,214 TZ11H122

3,215 TZ11H137

3,216 TZ11H001

3,217 TZ11H185

2 mg/5ml

Shelf life
month
24

5 mg/5ml

Manufacturer
Shelys Pharmaceuticals
Ltd.
TANZANIA

10 mg/5ml
50 mg/5ml

Chloramphenicol,Suspension

Chloramphenicol Palmitate
BP

125 mg/5ml

24

Thiamine HCl (B1) BP


Riboflavin BP
Pyridoxine HCl (B6) BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Mononitrate BP
Riboflavine BP

5.75 mg
2.5 mg
2.8 mg
22 mg
2 mg

36

Shelys Pharmaceuticals
Ltd.
TANZANIA

Becoshel,Syrup
Shelys Pharmaceuticals
Ltd.
TANZANIA

5 mg
2 mg

CO-MALATHER,Tablets

Artemether IH
Lumefantrine IH

20 mg
120 mg

24

Methyl Salicylate

10 %w/w

24

Shelys Pharmaceuticals
Ltd.
TANZANIA

Diclopar-Activa,Gel

Methyl Salicylate BP
3 %w/w
Linseed Oil BP
Diclofenac Diethylamine BP 1 %w/w
5 %w/w
Racementhol BP

Page 510 of 584

Shelys Pharmaceuticals
Ltd.
TANZANIA

Human Medicinal Products


S/No:

Registration Number

Registrant
3,218 TAN 00,4495 R06A SHI

3,219 TAN 00,4496 P02X SHI

3,220 TAN 00,4498 J01H SHI

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,222 TAN 00,4630 J01H SHI

3,223 TAN 05,205 C04A SHI

Manufacturer

Shiba Pharm & Chem Co. Ltd. - REP. OF YEMEN


Fenazine,Syrup

Promethazine Hydrochloride 5 mg/5ml


BP

36

Albendazole USP

200 mg

36

250 mg/5ml

36

Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

125 mg/5ml

36

Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

500 mg

36

Sildenafil Citrate IH

50 mg

36

Shiba Pharm & Chem Co.


Ltd.
REP. OF YEMEN

Albex,Tablet

Amoxacin,Powder for
Suspension

Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

3,221 TAN 00,4629 J01H SHI

Shelf life
month

Amoxacin,Powder for
Suspension

Shiba Pharm & Chem Co.


Ltd.
REP. OF YEMEN

Shiba Pharm & Chem Co.


Ltd.
REP. OF YEMEN

Shiba Pharm & Chem Co.


Ltd.
REP. OF YEMEN

Amoxacin,Capsules
Shiba Pharm & Chem Co.
Ltd.
REP. OF YEMEN

Supra,Tablet

Page 511 of 584

Shiba Pharm & Chem Co.


Ltd.
REP. OF YEMEN

Human Medicinal Products


S/No:

Registration Number

3,224 TAN 05,534 N02B SHI

3,225 TAN 05,815 N03A SHI

3,226 TAN 06,108 N02B SHI

3,227 TAN 06,336 D08A SHI

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,228 TAN 05,535 P01A SHI

Paracetamol USP

500 mg

36

Trihexyphenidyl
Hydrochloride USP

5 mg

36

Paracetamol USP

500 mg

36

3,229 TAN 05,207 J01H SHI

Shiba Pharm & Chem Co.


Ltd.
REP. OF YEMEN

Kinsol 5,Tablet
Shiba Pharm & Chem Co.
Ltd.
REP. OF YEMEN

Ramol,Tablet
Shiba Pharm & Chem Co.
Ltd.
REP. OF YEMEN

Hexadyl,Solution
36

Shiba Pharm & Chem Co.


Ltd.
REP. OF YEMEN

Shijiazhuang Huakang Pharmaceutical Co. Limited - CHINA


Metronidazole,Tablet

Metronidazole BP

Registrant

Manufacturer

Ramol,Tablet

Chlorhexidine Gluconate BP 2 %

Registrant

Shelf life
month

200 mg

36

Shijiazhuang Huakang
Pharmaceutical Co. Limited
CHINA

Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals - CHINA


Benzyl Penicillin,Powder for
Injection

Benzyl penicillin Sodium BP 5 Mega units

Page 512 of 584

36

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,230 TAN 05,208 J01H SHI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Benzathine Penicillin,Powder
for Injection

Benzathine Penicillin BP

3,231 TAN 05,206 J01H SHI

2.4 MU

Procaine penicillin,Powder for


Injection

Benzyl penicillin Sodium BP 1 MU


3 MU
Procaine Penicillin USP

Registrant
3,232 TAN 00,1507 D01A SHI

3,235 TAN 00,1693 A02B SHI

36

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

Cristan,Cream
10 mg/g

36

1 mg/g

24

Potassium Clavunate
125 mg
Equivalent to Clavulanic
Acid BP
Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin BP

24

Famotidine USP

36

Shin Poong Pharmaceutical


Co. Ltd.
KOREA

Gentamycin Sulphate,Cream

Gentamicin Sulphate
equivalent to Gentamicin
USP
3,234 TAN 06,210 J01C SHI

36

Manufacturer

Shin Poong Pharmaceutical Co. Ltd. - KOREA


Clotrimazole USP

3,233 TAN 00,1510 D06A SHI

Shelf life
month

Shin Poong Pharmaceutical


Co. Ltd.
KOREA

Clamoxin,Tablet
Shin Poong Pharmaceutical
Co. Ltd.
KOREA

Famtine,Tablet

Page 513 of 584

20 mg

Shin Poong Pharmaceutical


Co.Ltd
KOREA

Human Medicinal Products


S/No:

Registration Number

3,236 TAN 00,1513 N02B SHI

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,239 TAN 00,2201 M01A SHI

3,240 TAN 00,1505 S02C SHI

3,241 TAN 00,1508 P02X SHI

50 mg

36

0.1 mg

36

Shin Poong Pharmaceutical


Co.Ltd
KOREA

Bright,Ophthalmic Solution

Chlorpheniramine Maleate
USP
Naphazoline Hydrochloride
USP
Neostigmine Methyl
Sulphate USP
Aminocaproic acid USP
3,238 TAN 00,338 J01K SHI

Manufacturer

Loxfen,Tablet

Loxoprofen Sodium USP

3,237 TAN 07,105 S01D SHI

Shelf life
month

Spectinomycin,Powder for
Injection

0.02 mg

Shin Poong Pharmaceutical


Co.Ltd
KOREA

0.02 mg
0.1 mg

Spectinomycin
Hydrochloride IH

2g

36

Piroxicam USP

5 mg/g

24

Dexamethasone USP
Neomycin Sulphate USP
Polymyxin B Sulphate USP

100 mg
350 mg
600,000 Units

24

Prazinquatel USP

600 mg

60

Shin Poong Pharmaceutical


Co. Ltd.
KOREA

Rosiden,Gel

Porasone,Ophthalmic
Solution

Shin Poong Pharmaceutical


Co. Ltd.
KOREA

Shin Poong Pharmaceutical


Co.Ltd
KOREA

Distocide,Tablet

Page 514 of 584

Shin Poong Pharmaceutical


Co. Ltd.
KOREA

Human Medicinal Products


S/No:

Registration Number

3,242 TAN 00,1511 D06A SHI

3,243 TAN 00,1512 D01A SHI

3,244 TAN 10, 042A10B SHI

Registrant
3,245 TAN 00,2443 J01A SIM

3,246 TAN 00,2444 D01B SIM

3,247 TAN 00,2439 J01C SIM

Registrant

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Polybamycin,Ointment

Bacitracin USP
Neomycin Sulphate USP
Polymyxin B Sulphate USP

400 unit/g
3.5 mg/g
5000 unit/g

24

Clotrimazole USP

100 mg

36

Glimepiride USP

2 mg

36

Shin Poong Pharmaceutical


Co.Ltd
KOREA

Cristan,Pessaries
Shin Poong Pharmaceutical
Co.Ltd
KOREA

Climeril,Tablet
Shin Poong Pharmaceutical
Co.Ltd
KOREA

Simrone Pharmaceutical Industries Ltd. - INDIA


Doxycycline Hyclate,Capsules

Doxycycline Hyclate USP

100 mg

36

Griseofulvin BP

500 mg

36

Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

36

Simrone Pharmaceutical
Industries Ltd.
INDIA

Griseofulvin,Tablet
Simrone Pharmaceutical
Industries Ltd.
INDIA

Simclox,Capsules

Sirmaxo Chemical PVT LTD - INDIA

Page 515 of 584

Simrone Pharmaceutical
Industries Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

3,248 TZ10H078

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,249 TAN 07,221 M01A S K

3,250 TAN 07,224 P02A S K

3,251 TAN 07,222 J01F S K

3,252 TAN 07,223 A10B S K

3,253 TAN 07,225 D01A S K

Manufacturer

Sanicalamine,Lotion
15 %w/v

36

Sirmaxo Chemical PVT LTD


INDIA

Diclofenac Sodium BP

50 mg

36

S Kant Healthcare Ltd


INDIA

Praziquantel USP

600 mg

36

Skant Health care Ltd


INDIA

Azithromycin Dihydrate eq
to Azithromycin USP

500 mg

36

S Kant Healthcare Ltd


INDIA

Glibenclamide BP

5 mg

36

S Kant Healthcare Ltd


INDIA

Clotrimazole BP

1 %w/w

36

S Kant Healthcare Ltd


INDIA

Calamine BP

Registrant

Shelf life
month

SK Age Exports - INDIA


Diclokant,Tablet

Praziquantel,Tablet

Azithromycin,Capsules

Glibkant,Tablet

Skandid,Cream

Page 516 of 584

Human Medicinal Products


S/No:

Registration Number

3,254 TAN 07,400 A02B S K

3,255 TAN 07,401 J02A S K

3,256 TAN 10,044 A02B SKA

Registrant
3,257 TAN 00,1905 A02A SKB

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,258 TAN 09,139 A02B GSK

Cimetidine BP

400 mg

36

S Kant Healthcare Ltd


INDIA

Ketoconazole BP

2 %w/w

36

S Kant Healthcare Ltd


INDIA

Omeprazole BP

20 mg

36

S Kant Healthcare Ltd


INDIA

2.28 g/5g
0.88 g/5g

24

Smithsonian Institution
USA

Ketokant,Cream

Omesk,Capsules

SmithKline Beecham - FRANCE


Andrews Liver Salts,Powder

SmithKline Beecham Consumer Health Care Ltd. - KENYA


Tagamet,Injection

Cimetidine IH

Registrant
3,259 TAN 07,404 A11H SOF

Manufacturer

Cimekant,Tablet

Sodium Bicarbonate USP


Magnesium Sulphate USP

Registrant

Shelf life
month

200 mg/2ml

60

400 IU

24

SmithKline Beecham
Plc(Trading as SmithKline
Beech
UNITED KINGDOM

Softgel Health care Pvt Ltd. - INDIA


Tocosoft,Capsules

Vitamin E (as dl alpha


Tocopheryl Acetate) BP

Page 517 of 584

Softgel Health care Pvt Ltd.


INDIA

Human Medicinal Products


S/No:

Registration Number

Registrant
3,260 TAN 05,440 J01H SHI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Benzyl Penicillin,Powder for


Injection

5 MU

Benzyl Penicillin,Powder for


Injection

Benzyl penicillin Sodium BP 5 Mega units

3,262 TAN 05,208 J01H SHI

Benzathine Penicillin,Powder
for Injection

Benzathine Penicillin BP

3,263 TAN 05,206 J01H SHI

2.4 MU

Procaine penicillin,Powder for


Injection

Benzyl penicillin Sodium BP 1 MU


3 MU
Procaine Penicillin USP

Registrant
3,264 TAN 00,1247 N04C SOL

36

36

36

36

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

SOKOINE UNIVERSITY OF
AGRICULTURE
TANZANIA

Solvay Pharmaceuticals B.V - NETHERLANDS


Faverin,Tablet

Fluvoxamine Maleate Ph
Eur

3,265 TZ11H161

Manufacturer

SOKOINE UNIVERSITY OF AGRICULTURE - TANZANIA


Benzyl penicillin BP

3,261 TAN 05,207 J01H SHI

Shelf life
month

100 mg

36

Solvay Pharmaceuticals B.V


NETHERLANDS

200 mg

36

Solvay Pharmaceuticals
FRANCE

Duspatalin 200mg,Capsules

Mebeverine Hydrochloride
(None)

Page 518 of 584

Human Medicinal Products


S/No:

Registration Number

3,266 TZ11H158

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,267 TAN 05,209 J01C SPA

3,268 TAN 05,211 J01C SPA

135 mg

60

Solvay Pharmaceuticals
FRANCE

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

Sparsh Bio-tech PVT.Ltd.


INDIA

18

Sparsh Bio-tech PVT.Ltd.


INDIA

Amoxicillin Trihydrate eq to 250 mg


Amoxicillin BP

24

Sparsh Bio-tech PVT.Ltd.


INDIA

Amoxycillin BP

24

Sparsh Bio-tech PVT.Ltd.


INDIA

24

Sparsh Bio-tech PVT.Ltd.


INDIA

Sparsh Bio-tech PVT.Ltd. - INDIA


Spamox,Capsules

Spamox,Suspension

Amoxycillin Trihydrate BP

3,269 TAN 05,210 J01C SPA

3,270 TAN 06,448 J01H SPA

3,271 TAN 06,445 J01H SPA

Manufacturer

Duspatalin 135mg,Tablet

Mebeverine Hydrochloride
Ph Eur

Registrant

Shelf life
month

125 mg/5ml

Spamox,Tablet

Spamox,Capsules

Speniv,Powder for
Reconstitution

250 mg

Phenoxymethyl Penicillin BP 125 mg/5ml

Page 519 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

3,272 TAN 06,447 J01H SPA

Spamcil,Powder for
Reconstitution

3,273 TAN 06,443 J01C SPA

Ingredient(s) and Strength

3,275 TAN 06,446 J01C SPA

3,276 TAN 06,444 J01C SPA

Registrant
3,277 TAN 09,226 A02A SQU

Manufacturer

125 mg/5ml

24

Sparsh Bio-tech PVT.Ltd.


INDIA

125 mg/5ml
125 mg/5ml

18

Sparsh Bio-tech PVT.Ltd.


INDIA

Phenoxymethyl Penicillin BP 250 mg

24

Sparsh Bio-tech PVT.Ltd.


INDIA

Ampicillin BP
Cloxacillin BP

250 mg
250 mg

24

Sparsh Bio-tech PVT.Ltd.


INDIA

Cloxacillin BP

250 mg

24

Sparsh Bio-tech PVT.Ltd.


INDIA

Ampicillin BP

Spamclox,Powder for
Reconstitution

Ampicillin BP
Cloxacillin BP

3,274 TAN 06,449 J01H SPA

Shelf life
month

Speniv,Tablet

Spamclox,Capsules

Cloxispa,Capsules

Square pharmaceuticals Ltd. - Bangladesh


Entacyd Plus,Tablet

Dried Aluminium Hydroxide 425.53 mg


BP
Magnesium Trisilicate BP 400 mg
30 mg
Simethicone USP

Page 520 of 584

36

Square Pharmaceuticals
Ltd.
Bangladesh

Human Medicinal Products


S/No:

Registration Number

3,278 TAN 06,455 J01F SQU

Product Name
Pack and Pack size

Ingredient(s) and Strength

Zimax,Dry Powder for


Suspension

200 mg/5ml

24

Ambroxol Hydrochloride BP 0.3 g/100ml

24

Azithromycin Dihydrate
equivalent to Azithromycin
USP

3,279 TAN 06,454 R05C SQU

3,280 TAN 06,453 R05C SQU

Force 1 gm,Injectable
Solution

1g

Square Pharmaceuticals
Ltd.
Bangladesh

24

24

Square Pharmaceuticals
Ltd.
Bangladesh

Square Pharmaceuticals
Ltd.
Bangladesh

Entacyd Plus,Suspension
30 mg/5ml
Simethicone USP
Aluminium Oxide(Equivalent 200 mg/5ml
to Alminium Hydroxide Gel)
USP
Magnesium
400 mg/5ml
Hydroxide(Equivalent to
Magnesium Hydroxide
Paste USP

3,283 TAN 06,450 SQU

Square Pharmaceuticals
Ltd.
Bangladesh

Ambrox Paediatric,Solution

Cefpirome IH

3,282 TAN 06,451 A02A SQU

Manufacturer

Ambrox Syrup,Syrup

Ambroxol Hydrochloride BP 6 mg/ml

3,281 TAN 06,452 J01D SQU

Shelf life
month

24

Square Pharmaceuticals
Ltd.
Bangladesh

Cefdir,Powder for Suspension

cefdinir IH

125 mg/5ml

Page 521 of 584

24

Square Pharmaceuticals
Ltd.
Bangladesh

Human Medicinal Products


S/No:

Registration Number

3,284 TAN 07,106 V07A SQU

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,286 TAN 09,076 R03A SQU

3,287 TAN 09,224 M01A SQU

3,288 TAN 09,228 C06A SQU

3,289 TAN 09,227 J01D SQU

3,290 TAN 09,225 J03C SQU

Manufacturer

Osmolax,Solution

Lactulose USP

3,285 TAN 08,121 R06A SQU

Shelf life
month

3.4 mg/5ml

30

Square Pharmaceuticals
Ltd.
Bangladesh

Alatrol,Tablet

Cetrizine Hydrochloride BP 10 mg

36

Salmeterol Xinafoate eq to
Salmeterol IH

25 mcg

24

Aceclofenac USP

100 mg

24

Carvedilol IH

12.5 mg

24

cefdinir IH

300 mg

36

Lomefloxacin BP

3 mg/ml

24

Square Pharmaceuticals
Ltd.
Bangladesh

Salmate,Inhaler
Square Pharmaceuticals
Ltd.
Bangladesh

Flexi,Tablet
Square pharmaceuticals
Ltd.
Bangladesh

Durol,Tablet
Square Pharmaceuticals
Ltd.
Bangladesh

Cefdir,Capsules

Mexlo 0.3 % Eye


Drops,Solution

Page 522 of 584

Square Pharmaceuticals
Ltd.
Bangladesh

Square Pharmaceuticals
Ltd.
Bangladesh

Human Medicinal Products


S/No:

Registration Number

3,291 TAN 09,293 B04A SQU

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,292 TAN 00,1956 J07A SRP

Registrant
3,293 TAN 05,697 A16A SSL

3,294 TAN 05,700 V03A SSL

3,295 TAN 05,698 A02A SSL

Manufacturer

Anzitor,Tablet

Atorvastatin IH

Registrant

Shelf life
month

20 mg

24

--

60

Square Pharmaceuticals
Ltd.
Bangladesh

SR Pharma - UNITED KINGDOM


Mycobacterium
Vaccae,Suspension

Mycobacterium Vaccae IH

Centre For Applied


Microbiolgy and Research
UNITED KINGDOM

SSL International PLC - UNITED KINGDOM


Orovite,Tablet
48

Salama Pharmaceuticals
Ltd.
TANZANIA

Pyridoxine Hydrochloride
Ascorbic Acid Ph Eur
Thiamine Hydrochloride Ph
Eur
Ascorbic Acid Ph Eur
Riboflavine Ph Eur
Nicotinamide Ph Eur

5 mg

Almond Oil IH
Arachis Oil IH
Rectified Camphor oil IH

33.33 %v/v
33.33 %v/v
33.33 %v/v

60

SSL International PLC


UNITED KINGDOM

Aluminium Hydroxide BP
Dimethicone BP

500 mg
270 mg

24

SSL International PLC


UNITED KINGDOM

10 mg
100 mg
5 mg
33.3 mg

Earex,Solution

Asilone,Tablet

Page 523 of 584

Human Medicinal Products


S/No:

Registration Number

3,296 TAN 05,696 R05C SSL

Product Name
Pack and Pack size

Ingredient(s) and Strength

Adult Meltus for Dry Tickly


Coughs and
Catarrh,SuspensionDextromethorphan

SSL International PLC


UNITED KINGDOM

100 mg
30 mg

24

SSL International PLC


UNITED KINGDOM

Lamivudine USP

150 mg

24

Strides Arcolab Ltd.


INDIA

Nevirapine USP

200 mg

24

Strides Arcolab Ltd.


INDIA

Stavudine IH

40 mg

24

Strides Arcolab Ltd.


INDIA

Lamivudine IH
Stavudine IH

150 mg
40 mg

24

Strides Arcolab Ltd.


INDIA

Adult Meltus Chesty Coughs


with Decongestant,Solution

Guaiphenesin BP
Pseudoephedrine
Hydrochloride BP

Registrant
3,298 TAN 07,108 J05A STR

3,299 TAN 07,112 J05A STR

3,300 TAN 07,109 J05A STR

3,301 TAN 07,107 J05A STR

Manufacturer

36

Hydrobromide BP
Pseudoephedrine
Hydrochloride BP

3,297 TAN 05,699 R05C SSL

Shelf life
month

10 mg
10 mg

Strides Arcolab Ltd - INDIA


Lamivudine,Tablet

Nevirapine,Tablet

Stavudine,Capsules

Stavudine +
Lamivudine,Tablet

Page 524 of 584

Human Medicinal Products


S/No:

Registration Number

3,302 TAN 07,110 J05A STR

3,303 TAN 07,111 J05A STR

3,304 TAN 07,407 J05A STR

Registrant
3,305 TAN 07,235 J05A STR

3,306 TAN 07,405 J05A STR

3,307 TAN 07,408 J05A STR

Product Name
Pack and Pack size
Lamivudine +
Zidovudine,Tablet

Ingredient(s) and Strength

Shelf life
month

Manufacturer

150 mg
300 mg

24

Strides Arcolab Ltd.


INDIA

Lamivudine USP
Nevirapine IH
Stavudine IH

150 mg
200 mg
40 mg

24

Strides Arcolab Ltd.


INDIA

Stavudine USP

30 mg

24

Strides Arcolab Ltd.


INDIA

Lamivudine USP
Nevirapine USP
Zidovudine USP

150 mg
200 mg
300 mg

36

Strides Arcolab Ltd.


INDIA

Efavirenz IH

200 mg

36

Strides Arcolab Ltd.


INDIA

600 mg
150 mg
300 mg

24

Strides Arcolab Ltd.


INDIA

Lamivudine IH
Zidovudine IH

Stavudine + Lamivudine +
Nevirapine,Tablet

Stavudine,Capsules

Strides Arcolab Ltd. - INDIA


Lamivudine + Zidovudine +
Nevirapine,Tablet

Efavirenz,Tablet

Lamivudine + Zidovudine +
Efavirenz,Tablet

Efavirenz IH
Lamivudine USP
Zidovudine USP

Page 525 of 584

Human Medicinal Products


S/No:

Registration Number

3,308 TAN 07,406 J05A STR

3,309 TAN 09,229 J05A STR

Registrant
3,310 TAN 00,878 N05C SUN

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,312 TAN 00,2407 L02B SUN

Stavudine +
Lamivudine,Tablet

Efavirenz IH

600 mg

36

Strides Arcolab Ltd.


INDIA

Lamivudine USP
Stavudine USP

150 mg
30 mg

24

Strides Arcolab Ltd.


INDIA

Sun Pharmaceutical Industries Ltd. - INDIA


Zeptol,Tablet
200 mg

60

5 mg
Glibenclamide BP
Metformin Hydrochloride BP 500 mg

36

Sun Pharmaceutical
Industries Ltd.
INDIA

Glucored Forte,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Octride,Injectable Solution

Octreotide IH

3,313 TAN 00,4384 A10B SUN

Manufacturer

Efavirenz,Tablet

Carbamazepine BP

3,311 TAN 09,328 A10B SUN

Shelf life
month

0.1 mg/ml

24

Sun Pharmaceutical
Industries Ltd.
INDIA

Glucored Forte,Tablet
5 mg
Glibenclamide BP
Metformin Hydrochloride BP 500 mg

Page 526 of 584

36

Sun Pharmaceutical
Industries Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

3,314 TAN 00,4520 B04A SUN

3,315 TAN 00,4519 B04A SUN

3,316 TAN 05,701 R06A SUN

3,317 TAN 05,816 P01A SUN

3,318 TAN 05,817 N03A SUN

3,319 TAN 06,211 A02B SUN

3,320 TAN 06,213 C01K SUN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Aztor,Tablet

Atorvastatin Calcium
equivalent to Atorvastatin
IH

10 mg

24

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

24

Desloratadine IH

5 mg

24

Ornidazole IH

500 mg

36

Sodium Valproate BP

200 mg

36

Pantoprazole Sodium
Sesquihydrate eq to
Pantoprazole IH

40 mg

24

Amlodipine Besylate BP

5 mg

24

Sun Pharmaceutical
Industries Ltd.
INDIA

Aztor,Tablet
Sun Pharmaceutical
Industries Ltd.
INDIA

Dazit,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Dazolic,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Encorate,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Pantocid,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Amlosun,Tablet

Page 527 of 584

Sun Pharmaceutical
Industries Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

3,321 TAN 06,212 R06A SUN

3,322 TAN 06,337 A10B SUN

3,323 TAN 06,457 A02B SUN

3,324 TAN 06,458 A02B SUN

3,325 TAN 06,459 C06A SUN

3,326 TAN 06,456 A10B SUN

3,327 TAN 00,1908 C06A SUN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Cetrizet,Tablet

Cetrizine Hydrochloride BP 10 mg

36

Glimepiride USP

1 mg

24

Esomeprazole IH

40 mg

24

Esomeprazole Magnesium
Trihydrate equivalent to
Esomeprazole IH

20 mg

36

Carvedilol BP

6.25 mg

24

Glimepiride USP

2 mg

24

Carvedilol IH

12.5 mg

24

Sun Pharmaceutical
Industries Ltd
INDIA

Glypride 1,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Sompraz,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Sompraz,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Cardivas 6.25,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Glypride 2,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Cardivas,Tablet

Page 528 of 584

Sun Pharmaceutical
Industries Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

3,328 TAN 00,1910 A02B SUN

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,331 TAN 07,594 A10B SUN

3,332 TAN 07,595 A10B SUN

3,333 TAN 07,591 A02C SUN

3,334 TAN 07,593 C01E SUN

24

Sun Pharmaceutical
Industries Ltd
INDIA

Octride,Injectable Solution
0.1 mg/ml

24

Octreotide IH

0.1 mg/ml

24

Pioglitazone Hydrocloride
equivalent Pioglitazone IH

15 mg

24

Pioglitazone Hydrocloride
equivalent Pioglitazone IH

30 mg

24

Gabapentin IH

300 mg

24

Irbesartan USP

300 mg

24

Octreotide IH

3,330 TAN 00,2407 L02B SUN

Manufacturer

Pantocid,Tablet

Pantoprazole Sodium
40 mg
Sesquihydrate equivalent to
Pantoprazole IH
3,329 TAN 00,2407 L02B SUN

Shelf life
month

Sun Pharmaceutical
Industries Ltd.
INDIA

Octride,Injectable Solution
Sun Pharmaceutical
Industries Ltd.
INDIA

Pioglit,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Pioglit,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Gabantin,Capsules
Sun Pharmaceutical
Industries Ltd
INDIA

Irovel,Tablet

Page 529 of 584

Sun Pharmaceutical
Industries Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

3,335 TAN 07,592 A10B SUN

3,336 TAN 07,589 A10B SUN

3,337 TAN 08,087 C01E SUN

3,338 TAN 08,086 R06A SUN

3,339 TAN 00,1719 M01A SUN

3,340 TAN 00,1909 C06A SUN

3,341 TAN 00,1911 A02B SUN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Gemer,Tablet

Metformin Hydrochloride BP 500 mg


1 mg
Glimepiride USP

24

Metformin Hydrochloride BP 500 mg


2 mg
Glimepiride USP

24

Irbesartan USP

150 mg

24

Cetrizine Hydrochloride BP 5 mg
Pseudoephedrine
120 mg
Hydrochloride BP

24

Meloxicam BP

7.5 mg

24

Meloxicam BP

15 mg

24

Pantoprazole USP

40 mg/ml

24

Sun Pharmaceutical
Industries Ltd
INDIA

Gemer,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Irovel,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Cetrizet D,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Muvera,Tablet
Sun Pharmaceutical
Industries Ltd.
INDIA

Muvera,Tablet
Sun Pharmaceutical
Industries Ltd.
INDIA

Pantocid,Injection

Page 530 of 584

Sun Pharmaceutical
Industries Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

3,342 TAN 00,1911 A02B SUN

3,343 TAN 00,2646 A10B SUN

3,344 TAN 00,4172 A10B SUN

3,345 TAN 00,4385 A10B SUN

3,346 TAN 00,4520 B04A SUN

3,347 TAN 00,4520 B04A SUN

3,348 TAN 00,4519 B04A SUN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Pantocid,Injectable Solution

Pantoprazole IH

40 mg/ml

24

Rosiglitazone Maleate IH

2 mg

24

Rosiglitazone Maleate IH

4 mg

24

Sun Pharmaceutical
Industries Ltd.
INDIA

Rezult,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Rezult,Tablet
Sun Pharmaceutical
Industries Ltd
INDIA

Glucored,Tablet
2.5 mg
Glibenclamide BP
Metformin Hydrochloride BP 400 mg

36

Atorvastatin Calcium
equivalent to Atorvastatin
IH

10 mg

24

Atorvastatin Calcium
equivalent to Atorvastatin
IH

10 mg

24

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

24

Sun Pharmaceutical
Industries Ltd
INDIA

Aztor,Tablet
Sun Pharmaceutical
Industries Ltd.
INDIA

Aztor,Tablet
Sun Pharmaceutical
Industries Ltd.
INDIA

Aztor,Tablet

Page 531 of 584

Sun Pharmaceutical
Industries Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

3,349 TAN 00,4519 B04A SUN

3,350 TAN 09,230 C01L SUN

Registrant
3,351 TAN 00,892 J04A SVI

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,352 TAN 08,113 N01B T

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

24

Hydrochlorthiazide BP
Irbesartan USP

12.5 mg
150 mg

24

400 mg

60

3,353 TAN 00,592 C04A T3A

Sun Pharmaceutical
Industries Ltd
INDIA

Svizera Laboratories - INDIA


Ethambutol + Isoniazid,Tablet
Svizera Laboratories
INDIA

150 mg

T & T Pharma Care - INDIA


Mistdress Spray,Spray
0.1 %w/w
1 %w/w

36

400 mg

48

Midas Care
Pharmaceuticals Pvt. Ltd
INDIA

T3A Pharma Group - EGYPT


Vasotal,Tablet

Pentoxifylline NA

Registrant

Sun Pharmaceutical
Industries Ltd.
INDIA

Irovel H,Tablet

Cetrimide BP
Lidocaine Hydrochloride
USP

Registrant

Manufacturer

Aztor,Tablet

Ethambutol Hydrochloride
BP
Isoniazid BP

Registrant

Shelf life
month

Tablets (India) Ltd. - INDIA

Page 532 of 584

T3 Industrial
EGYPT

Human Medicinal Products


S/No:

Registration Number

3,354 TAN 00,2058 M01A TAB

Product Name
Pack and Pack size

Ingredient(s) and Strength

200 mg

48

Tablets (India) Ltd.


INDIA

3.8 mg
8.11 mg

24

Tablets (India) Ltd.


INDIA

Astymin-SN,Solution

L-Aspartic acid BP
L-Histidine Hydrochloride
IH
L-Glutamic acid IH
L-Isoleucine USP
L-Leucine USP
L-Phenylalanine USP
L-Threonine USP
L-Tryptophan USP
L-Valine USP
L-Glycine USP
L-Lysine Hydrochloride USP
L-Methionine USP
L-Cysteine Hcl USP
L-Alanine USP
L-Arginine Hcl USP
L-Proline USP
L-Serine USP
L-Tyrosine USP
Xylitol USP
3,356 TAN 09,231 A16A TAB

Manufacturer

Profundin,Tablet

Ibuprofen BP

3,355 TAN 05,055 A16A TAB

Shelf life
month

Astyfer,Suspension

Page 533 of 584

6.5 mg
5.6 mg
12.5 mg
9.5 mg
6.5 mg
1.3 mg
4.5 mg
10.7 mg
11 mg
3.5 mg
1.45 mg
6.2 mg
9.55 mg
3.3 mg
2.2 mg
0.35 mg
50 mg

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Pyridoxine Hydrochloride
BP
Thiamine Hydrochloride BP
Folic Acid BP
Cynacobalamine BP
Riboflavin BP
Nicotinamide BP
Ferrous Glycine Sulphate IH
L-Histidine Hydrochloride
IH
L-Lysine Hydrochloride USP
Dexpanthenol USP

Registrant
3,357 E060

3,360 B275

Tablets (India) Ltd.


INDIA

8.5 mg/10ml
0.625 mg/10ml
3.25 mcg/10ml
5.35 mg/10ml
28.75 mg/10ml
275 mg/10ml
6 mg/10ml
30 mg/10ml
3.125 mg/10ml

Phenobarbitone BP,Tablet
30 mg

24

200 mg/5ml
40 mg/5ml

24

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

60

Paracetamol BP

500 mg

60

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Co Trimoxazole,Suspension

Sulfamethoxazole BP
Trimethoprim BP

3,359 B274

18

Manufacturer

Tanzania Pharmaceuticals Industries Ltd. (TPI) - TANZANIA


Phenobarbitone BP

3,358 E061

2.1 mg/10ml

Shelf life
month

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Co-trimoxazole,Tablet
Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Paracetamol,Tablet

Page 534 of 584

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,361 B276

Product Name
Pack and Pack size

Ingredient(s) and Strength

Pyrimethamine +
Sulphadoxine,Tablet

Pyrimethamine BP
Sulfadoxine BP

3,365 C804

4 mg

24

100 mg

24

25 mg
500 mg

24

200 mg

24

30 mg

24

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Amodiaquine,Tablet

Amodiaquine BP

3,366 C805

60

Mebendazole,Tablet

Mebendazole BP

3,364 C803

200 mg

Chlorpheniramine,Tablet

Chlorpheniramine Maleate
BP

3,363 C802

Manufacturer

Metronidazole,Tablet

Metronidazole BP

3,362 C801

Shelf life
month

Ephedrine
Hydrochloride,Tablet

Ephedrine Hydrochloride
BP

Page 535 of 584

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,367 D070

3,368 D254

3,369 D626

3,370 E062

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,372 TAN 05,882 J05A TAN

Manufacturer

Tulizamol,Syrup

Paracetamol BP

120 mg/5ml

36

Dextromethorphan
Hydrobromide BP
Chlorpheniramine Maleate
BP

1.5 mg/5ml

36

Bromhexine Hydrochloride
BP
Guaiphenesin BP
Menthol BP
Terbutaline Sulphate BP

2 mg/5ml

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Totokof,Syrup

1 mg/5ml

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Mucodil Plus,Syrup

Chlorpromazine
Hydrochloride,Tablet

Chlorpromazine
Hydrochloride BP

3,371 E063

Shelf life
month

36

50 mg/5ml
0.5 mg/5ml
1.25 mg/5ml

25 mg

24

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Erythromycin,Suspension

Erythromycin Estolate USP 125 mg/5ml

24

Lamivudine IH
Nevirapine IH
Stavudine IH

24

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

TT-VIR 30,Tablet

Page 536 of 584

150 mg
200 mg
30 mg

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,373 TAN 05,881 J05A TAN

3,374 E292

3,375 E293

3,376 E294

Product Name
Pack and Pack size

Ingredient(s) and Strength

Lamivudine IH
Nevirapine IH
Stavudine IH

150 mg
200 mg
30 mg

24

Eryrthromycin Stearate BP

250 mg

36

Diazepam BP

5 mg

36

100 mg

36

10 %w/v

36

50 mg

36

300 mg

24

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Diazepam,Tablet
Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Phenobarbitone BP,Tablet
Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Povidone Iodine,Solution
Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Diclofenac Sodium,Tablet

Diclofenac Sodium BP

3,379 E309

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Erythromin,Tablet

Povidone Iodine BP

3,378 E306

Manufacturer

TT-VIR 40,Tablet

Phenobarbitone BP

3,377 E305

Shelf life
month

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Quinine Sulphate,Tablet

Quinine Sulphate BP

Page 537 of 584

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,380 E310

Product Name
Pack and Pack size

Ingredient(s) and Strength

100 mg

3,383 E314

3,384 E315

3,385 E319

3,386 E321

36

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Amodiaquine,Suspension

Amodiaquine Hydrochloride 50 mg/5ml


BP

3,382 E313

Manufacturer

Chlorpromazine,Tablet

Chlorpromazine
Hydrochloride BP

3,381 E312

Shelf life
month

36

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Ciprofloxacin,Tablet

Ciprofloxacin Hydrochloride 250 mg


BP

36

Folic Acid BP

5 mg

24

Ibuprofen BP

200 mg

36

Phenobarbitone BP

30 mg

36

Codeine Phosphate BP
Ammonium Chloride BP
Chlorpheniramine Maleate
BP

10 mg/5ml
100 mg/5ml
4 mg/5ml

36

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Folic Acid,Tablet
Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Ibuprofen,Tablet
Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Phenobarbitone BP,Tablet
Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Sedakof,Syrup

Page 538 of 584

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,387 E322

3,388 TAN 07,236 J05A TAN

Registrant
3,389 B855

Product Name
Pack and Pack size

Ingredient(s) and Strength

Prazinquatel USP

600 mg

36

Lamivudine IH

150 mg

24

3,392 B867

Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Lamivudine,Tablet
Tanzania Pharmaceuticals
Industries Ltd. (TPI)
TANZANIA

Tanzansino United Pharmaceuticals Ltd - TANZANIA


Paracetamol,Tablet
500 mg

36

200 mg

24

Indomethacin BP

25 mg

36

Acetylsalicylic Acid BP

300 mg

36

Tanzansino United
Pharmaceuticals Ltd
TANZANIA

Metronidazole,Tablet

Metronidazole BP

3,391 D627

Manufacturer

Praziquantel,Tablet

Paracetamol BP

3,390 D621

Shelf life
month

Tanzansino United
Pharmaceuticals Ltd
TANZANIA

Indomethacin,Capsules
Tanzansino United
Pharmaceuticals Ltd
TANZANIA

Aspirin,Tablet

Page 539 of 584

Tanzansino United
Pharmaceuticals Ltd
TANZANIA

Human Medicinal Products


S/No:

Registration Number

3,393 D584

Product Name
Pack and Pack size

Ingredient(s) and Strength

Compound Magnesium
Trisilicate,Tablet

Aluminium Hydroxide BP
Magnesium Trisilicate BP

3,395 D498

3,396 TAN 00,1729 G03H TAD

3,398 TAN 00,1915 R04A TMC

120 mg
250 mg

24

50 mg

36

50 mg

36

The Arab Drug Company


EGYPT

1.09 mg/ml
69.1 mg/ml
0.268 mg/ml

36

The Arab Drug Company


EGYPT

Tanzansino United
Pharmaceuticals Ltd
TANZANIA

Tanzansino United
Pharmaceuticals Ltd
TANZANIA

Clomiphene,Tablet

Halorange Vit,Emulsion

Ascorbic Acid USP


Vitamin A USP
Cholecalciferol USP

Registrant

24

The Arab Drug Company - EGYPT


Clomifene Citrate Ph Eur

3,397 TAN 00,2061 A11A TAD

Tanzansino United
Pharmaceuticals Ltd
TANZANIA

200 mg

Diclofenac Sodium,Tablet

Diclofenac Sodium BP

Registrant

Manufacturer

Albendazole,Tablet

Albendazole USP

3,394 D622

Shelf life
month

The Mentholatum Company Ltd. - UNITED KINGDOM


Mentholatum Balm,Ointment

Page 540 of 584

Human Medicinal Products


S/No:

Registration Number

3,399 TAN 00,1916 M02A TMC

3,400 TAN 00,1917 M02A TMC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Camphor oil BP
Methyl Salicylate

9 %w/w
0.33 %w/w

Methyl Salicylate BP
Menthol BP

1.35 %w/w

Eucalyptus Oil BP
Methyl Salicylate

1.97 %w/w
12.8 %w/w

Methyl Salicylate BP
Turpentine Oil BP
Racementhol BP

1.47 %w/w
5.91 %w/w

The Mentholatum Company


Ltd.
UNITED KINGDOM

24

The Mentholatum Company


Ltd.
UNITED KINGDOM

Deep Heat,Aerosol

Methyl Salicylate BP
Methyl Nicotinate BP
Ethyl Salicylate BP

3,401 TAN 05,538 D01A THO

24

Manufacturer

Deep Heat Rub,Cream

2-Hydroxyethyl Salicylate
BP
Methyl Salicylate

Registrant

Shelf life
month

5 %w/w

24

1 %w/w

CCL Pharmaceuticals PVT.


Ltd.
PAKISTAN

1.6 %w/w
5 %w/w

Thornton & Ross Ltd. - UNITED KINGDOM


Mycota,Powder

Zinc Undecenoate BP
Undecenoic Acid BP

Page 541 of 584

20 %w/w
2 %w/w

36

SSL International PLC


UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

3,402 TAN 05,537 D01A THO

3,403 TAN 05,536 D01A THO

3,404 TAN 05,538 D01A THO

3,405 TAN 05,538 D01A THO

3,406 TAN 05,537 D01A THO

3,407 TAN 05,537 D01A THO

3,408 TAN 05,536 D01A THO

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Mycota,Spray
CCL Pharmaceuticals PVT.
Ltd.
PAKISTAN

Undecenoic Acid BP
Dichlorophen BP

3.9 %w/w
0.4 %w/w

36

Zinc Undecenoate Ph Eur


Undecenoic Acid Ph Eur

20 %w/w
5 %w/w

36

SSL International PLC


UNITED KINGDOM

Zinc Undecenoate BP
Undecenoic Acid BP

20 %w/w
2 %w/w

36

SSL International PLC


UNITED KINGDOM

Zinc Undecenoate BP
Undecenoic Acid BP

20 %w/w
2 %w/w

36

SSL International PLC


UNITED KINGDOM

Undecenoic Acid BP
Dichlorophen BP

3.9 %w/w
0.4 %w/w

36

Undecenoic Acid BP
Dichlorophen BP

3.9 %w/w
0.4 %w/w

36

Zinc Undecenoate Ph Eur


Undecenoic Acid Ph Eur

20 %w/w
5 %w/w

36

Mycota,Cream

Mycota,Powder

Mycota,Powder

Mycota,Spray
CCL Pharmaceuticals PVT.
Ltd.
PAKISTAN

Mycota,Spray
CCL Pharmaceuticals PVT.
Ltd.
PAKISTAN

Mycota,Cream

Page 542 of 584

SSL International PLC


UNITED KINGDOM

Human Medicinal Products


S/No:

Registration Number

3,409 TAN 05,536 D01A THO

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,410 TAN 05,883 V07A MUC

3,411 TZ11H179

3,412 TAN 06,109 C01E TOR

3,413 TAN 10, 087 N04A TOR

36

SSL International PLC


UNITED KINGDOM

500 mg
30 mg
20 mg
20 mg
100 mg
25 mg
50 mg

36

Tishchon Corporation
USA

Multivitamins,Tablet

TORRENT PHARMACEUTICAL LTD - INDIA


Azulix 2,Tablet

Glimepiride USP

Registrant

20 %w/w
5 %w/w

Tishchon Corporation - USA


Vitamin A USP
Vitamin E USP
Thiamine Mononitrate USP
Riboflavine USP
Niacinamide USP
Pyridoxine USP
Cyanocobalamin USP

Registrant

Manufacturer

Mycota,Cream

Zinc Undecenoate Ph Eur


Undecenoic Acid Ph Eur

Registrant

Shelf life
month

2 mg

24

Torrent Pharmaceuticals
Ltd
INDIA

Torrent Pharmaceuticals Ltd. - INDIA


Listril-5,Tablet

Lisinopril dehydrate USP

5 mg

36

Lamotrigine IH

100 mg

36

Torrent Pharmaceuticals
Ltd
INDIA

Lamitor 100,Tablet

Page 543 of 584

Torrent Pharmaceuticals
Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

3,414 TAN 05,543 A04A TOR

3,415 TAN 06,110 C01E TOR

3,416 TAN 06,111 N03A TOR

3,417 TAN 06,113 J01D TOR

3,418 TAN 06,112 C01E TOR

3,419 TAN 07,113 B01A TOR

3,420 TAN 07,115 C01K TOR

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Domstal,Tablet

Domperidone BP

10 mg

48

Lisinopril dehydrate USP

10 mg

36

Sodium Valproate BP

200 mg

36

Cefixime Trihydrate USP

200 mg

24

Losartan Potasium IH

50 mg

24

Clopidogrel Bisulfate IH

75 mg

24

Amlodipine Besylate IH

2.5 mg

24

Torrent Pharmaceuticals
Ltd
INDIA

Listril-10,Tablet
Torrent Pharmaceuticals
Ltd
INDIA

Valparin 200 Alkalets,Tablet


Torrent Pharmaceuticals
Ltd
INDIA

Topcef 200,Tablet
Torrent Pharmaceuticals
Ltd
INDIA

Tozaar-50,Tablet
Torrent Pharmaceuticals
Ltd
INDIA

Deplatt,Tablet
Torrent Pharmaceuticals
Ltd
INDIA

Esam,Tablet

Page 544 of 584

Torrent Pharmaceuticals
Ltd
INDIA

Human Medicinal Products


S/No:

Registration Number

3,421 TAN 07,114 C01K TOR

Product Name
Pack and Pack size

Ingredient(s) and Strength

5 mg

24

150 mg

36

3,425 TAN 00,4386 S01B TUB

Torrent Pharmaceuticals
Ltd
INDIA

25 mg

36

0.1 g/100ml

36

Tubilux Pharma
ITALY

0.5 g
1.5 g

36

Tubilux Pharma
ITALY

Tubilux Pharma - ITALY


Fluaton PVA,Ophthalmic
Solution

Fluorometholone USP

3,426 TAN 00,4387 S01C TUB

Rotexmedica GMBH
GERMANY

Lamitor 25,Tablet

Lamotrigine IH

Registrant

Torrent Pharmaceuticals
Ltd
INDIA

Herpex,Tablet
24

3,424 TAN 10, 088 N04A TOR

Torrent Pharmaceuticals
Ltd
INDIA

Syscan 150,Capsules

Fluconazole USP

3,423 TAN 10, 045 J045A TOR

Manufacturer

Esam,Tablet

Amlodipine Besylate IH

3,422 TAN 07,599 J02A TOR

Shelf life
month

Cortisomicina,Ophthalmic
Solution

Neomycin Sulphate EP
Cortisone Acetate EP

Page 545 of 584

Human Medicinal Products


S/No:

Registration Number

3,427 TAN 00,4469 S01D GEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Stop Allerg,Ophthalmic
Solution

36

Tubilux Pharma
ITALY

5 mg/ml
335000IU IU/ml
66 mg/ml

24

Tubilux Pharma
ITALY

Levocetrizine
dihydrochloride IH

5 mg

36

UCB Farchim SA
SWITZERLAND

Cetrizine Dihydrochloride
Ph Eur
Pseudoephedrine
Hydrochloride Ph Eur

5 mg

36

UCB Farchim SA
SWITZERLAND

Levocetrizine
dihydrochloride IH

0.5 mg/5ml

24

Pharmacare Ltd.
SOUTH AFRICA

Allerdex,Ophthalmic Solution

Gramicidin USP
Framycetin Sulphate EP
Dexamethasone Sodium
Phosphate USP

Registrant
3,429 TAN 06,214 R06A UCB

3,430 TAN 07,237 R06A UCB

3,431 TAN 09,077 R06A UCB

Registrant
3,432 TAN 00,1264 R03A UME

Manufacturer

20 mg/ml

Sodium Cromoglycate Ph
Eur

3,428 TAN 00,4254 S01C TUB

Shelf life
month

UCB(SA) Pty Ltd. - SOUTH AFRICA


Xyzal,Tablet

Cirrus,Tablet

120 mg

Xyzal,Solution

Umedica Laboratories Pvt Ltd. - INDIA


Aminophylline,Tablet

Aminophylline BP

Page 546 of 584

100 mg

24

Umedica Laboratories Pvt


Ltd.
INDIA

Human Medicinal Products


S/No:

Registration Number

3,433 TAN 00,1261 P02X UME

3,434 TAN 00,1262 D01B UME

Registrant
3,435 TAN 00,905 J01C UNI

3,436 TAN 00,4578 J01C UNI

3,437 TAN 00,4577 J01C UNI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Mebendazole,Tablet
Umedica Laboratories Pvt
Ltd.
INDIA

Mebendazole USP

100 mg

36

Griseofulvin BP

500 mg

36

250 mg
Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

24

Unichem Laboratories Ltd.


INDIA

Clavulanate Potassium IH
Amoxycillin Trihydrate USP
Amoxicillin Trihydrate USP
Amoxicillin Trihydrate
equivalent to Amoxicillin
USP

24

Unichem Laboratories Ltd.


INDIA

24

Unichem Laboratories Ltd.


INDIA

24

Unichem Laboratories Ltd.


INDIA

Griseofulvin,Tablet
Umedica Laboratories Pvt
Ltd.
INDIA

Unichem Laboratories Ltd. - INDIA


Ampoxin,Capsules

Myclav,Tablet
125 mg
596.800 mg
596.800 mg
250 mg

Myclav,Tablet

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin
USP
3,438 TAN 00,897 A09A UNI

Shelf life
month

Unienzyme MPS,Tablet

Activated Charcoal BP
Nicotinamide BP
Fungal Diastase IH
Papain USP
Simethicone USP
Page 547 of 584

75
25
34
60
50

mg
mg
mg
mg
mg

Human Medicinal Products


S/No:

Registration Number

3,439 TAN 00,4420 J01H UNI

3,440 TAN 00,4499 J01H UNI

3,441 TAN 00,905 J01C UNI

3,442 TAN 00,905 J01C UNI

3,443 TAN 00,1266 N02B UNI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

36

Unichem Laboratories Ltd.


INDIA

Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin BP

24

Unichem Laboratories Ltd.


INDIA

250 mg
Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

24

Unichem Laboratories Ltd.


INDIA

250 mg
Ampicillin BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

24

Unichem Laboratories Ltd.


INDIA

24

Unichem Laboratories Ltd.


INDIA

24

Unichem Laboratories Ltd.


INDIA

Mymox,Capsules

Ampoxin,Capsules

Ampoxin,Capsules

Domadol,Injectable Solution

Domadol,Injectable Solution

Tramadol Hydrochloride Ph 50
Eur

3,445 TAN 00,4577 J01C UNI

Manufacturer

Mymox,Capsules

Tramadol Hydrochloride Ph 50
Eur

3,444 TAN 00,1266 N02B UNI

Shelf life
month

Myclav,Tablet

Page 548 of 584

Human Medicinal Products


S/No:

Registration Number

3,446 TAN 00,145 P01X UNI

3,447 TAN 00,898 N02B UNI

3,448 TAN 00,899 N05A UNI

3,449 TAN 00,901 J01K UNI

3,450 TAN 00,903 C01K UNI

3,451 TAN 00,906 P01A UNI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Clavulanate Potassium USP 125 mg


Amoxicillin Trihydrate eq to 250 mg
Amoxicillin USP
Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin
USP

30

Unichem Laboratories Ltd.


INDIA

Metronidazole BP

60

Unichem Laboratories Ltd.


INDIA

Tramadol Hydrochloride Ph 50 mg
Eur

36

Unichem Laboratories Ltd.


INDIA

Fluoxetine Hydrochloride
USP

20 mg

36

Unichem Laboratories Ltd.


INDIA

Sultamicillin IH

375 mg

24

Unichem Laboratories Ltd.


INDIA

Amlodipine Besylate BP

5 mg

36

Unichem Laboratories Ltd.


INDIA

1g

36

Unichem Laboratories Ltd.


INDIA

Unimezol,Tablet
200 mg

Domadol,Capsules

Trizac,Capsules

Sulbacin,Tablet

Corvadil,Tablet

Tagera Forte,Tablet

Secnidazole
Secnidazole IH

Page 549 of 584

Human Medicinal Products


S/No:

Registration Number

3,452 TAN 00,907 C01K UNI

3,453 TAN 00,896 A02B UNI

3,454 TAN 07,116 M01A UNI

3,455 TAN 07,117 M01A UNI

3,456 TAN 10,072, C06A

3,457 TAN 10,073 C06A

3,458 TAN 00,4578 J01C UNI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Corvadil,Tablet

Amlodipine Besylate IH

10 mg

36

Unichem Laboratories Ltd.


INDIA

Lansoprazole IH

30 mg

24

Unichem Laboratories Ltd.


INDIA

Meloxicam IH

15 mg

36

Unichem Laboratories Ltd.


INDIA

Meloxicam IH

7.5 mg

36

Unichem Laboratories Ltd.


INDIA

bisoprolol Fumarate USP

5 mg

36

Unichem Laboratories Ltd.


INDIA

bisoprolol Fumarate USP

10 mg

36

Unichem Laboratories Ltd.


INDIA

Lanpro,Capsules

M-Cam,Tablet

M-Cam,Tablet

Corbis 5,Tablet

Corbis 10,Tablet

Myclav,Tablet

Page 550 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,460 TAN 00,898 N02B UNI

3,461 TAN 00,901 J01K UNI

3,462 TAN 00,901 J01K UNI

3,463 TAN 00,898 N02B UNI

3,464 TAN 00,899 N05A UNI

Manufacturer

24

Unichem Laboratories Ltd.


INDIA

Tramadol Hydrochloride Ph 50
Eur

36

Unichem Laboratories Ltd.


INDIA

Tramadol Hydrochloride Ph 50
Eur

36

Unichem Laboratories Ltd.


INDIA

Sultamicillin IH

375

24

Unichem Laboratories Ltd.


INDIA

Sultamicillin IH

375

24

Unichem Laboratories Ltd.


INDIA

Tramadol Hydrochloride Ph 50 mg
Eur

36

Unichem Laboratories Ltd.


INDIA

Fluoxetine Hydrochloride
USP

36

Unichem Laboratories Ltd.


INDIA

Clavulanate Potassium IH
Amoxycillin Trihydrate USP
Amoxicillin Trihydrate USP
Amoxicillin Trihydrate
equivalent to Amoxicillin
USP
3,459 TAN 00,898 N02B UNI

Shelf life
month

125 mg
596.800 mg
596.800 mg
250 mg

Domadol,Capsules

Domadol,Capsules

Sulbacin,Tablet

Sulbacin,Tablet

Domadol,Capsules

Trizac,Capsules

Page 551 of 584

20 mg

Human Medicinal Products


S/No:

Registration Number

3,465 TAN 00,901 J01K UNI

3,466 TAN 00,903 C01K UNI

3,467 TAN 00,906 P01A UNI

3,468 TAN 00,907 C01K UNI

Registrant
3,469 TAN 00,404 D07X UNI

3,470 TAN 00,1267 N02B UNQ

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Sulbacin,Tablet

Sultamicillin IH

375 mg

24

Unichem Laboratories Ltd.


INDIA

Amlodipine Besylate BP

5 mg

36

Unichem Laboratories Ltd.


INDIA

Secnidazole
Secnidazole IH

1g

36

Unichem Laboratories Ltd.


INDIA

Amlodipine Besylate IH

10 mg

36

Unichem Laboratories Ltd.


INDIA

Corvadil,Tablet

Tagera Forte,Tablet

Corvadil,Tablet

Unique Pharmaceutical Laboratories Ltd. - INDIA


Ecodax G,Cream

Betamethasone
Dipropionate NA
Gentamycin Sulphate BP
Econazole Nitrate BP

2.5 mg/10g

Diclofenac Sodium IH
Methyl Salicylate

1 %w/w
10 %w/w

Methyl Salicylate BP
Menthol BP
Oleum Lini BP

5 %w/w
3 %w/w

24

10 mg/10g
100 mg/10g

Unique Pharmaceutical
Laboratories ( A div. of J.B.
Chemicals and
Pharmaceuticals Ltd.)
INDIA

Dicloran MS,Gel

Page 552 of 584

18

Unique Pharmaceutical
Laboratories ( A div. of J.B.
Chemicals and
Pharmaceuticals Ltd.)
INDIA

Human Medicinal Products


S/No:

Registration Number

3,471 TAN 00,306 P01A UNI

3,472 TAN 06,466 B04A UNI

3,473 TAN 06,467 B04A UNI

3,474 TAN 07,240 C01K UNI

Product Name
Pack and Pack size

Ingredient(s) and Strength

36

Atorvastatin Calcium eq to
Atorvastatin IH

10 mg

36

Unichem Laboratories Ltd.


INDIA

Atorvastatin Calcium
equivalent to Atorvastatin
IH

20 mg

36

Unichem Laboratories Ltd.


INDIA

50 mg
20 mg

36

500 mg

36
month
s

1000 mg

36

Vasolip,Tablet

Vasolip,Tablet

Beta Nicardia,Capsules
Unique Pharmaceutical
Laboratories ( A div. of J.B.
Chemicals and
Pharmaceuticals Ltd.)
INDIA

Ificipro OD 500,Tablet
Rotexmedica GMBH
GERMANY

Ificipro OD 1000,Tablet

Ciprofloxacin BP

3,477 TAN 00,307 P01X UNI

Unique Pharmaceutical
Laboratories ( A div. of J.B.
Chemicals and
Pharmaceuticals Ltd.)
INDIA

Metronidazole Sodium USP 5 mg/ml

Ciprofloxacin BP

3,476 TAN 07,238 J01K UNI

Manufacturer

Metrogyl,Solution

Atenolol BP
Nifedipine BP

3,475 TAN 07,239 J01K UNI

Shelf life
month

Metrogyl,Tablet

Page 553 of 584

Rotexmedica GMBH
GERMANY

Human Medicinal Products


S/No:

Registration Number

3,478 TAN 00,1271 M01A UNQ

3,479 TAN 10,046 C04A UNI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Metronidazole BP

200 mg

36

Diclofenac Sodium USP

50 mg

36

70.24 mg

24

1000 mg

24

755 mg

48

3,482 TAN 05,546 R06A UNI

Unique Pharmaceutical
Laboratories Ltd.( A Div of
J.B. Chemicals and
Pharmaceuticals Ltd.)
INDIA
Unique Pharmaceutical
Laboratories ( A div. of J.B.
Chemicals and
Pharmaceuticals Ltd.)
INDIA

Ificef,Powder for Injection


Unique Pharmaceutical
Laboratories Ltd.( A Div of
J.B. Chemicals and
Pharmaceuticals Ltd.)
INDIA

Contrapaque,Injection

Iohexol USP

Registrant

Unique Pharmaceutical
Laboratories Ltd.( A Div of
J.B. Chemicals and
Pharmaceuticals Ltd.)
INDIA

Andromax 50,Tablet

Ceftriaxone USP

3,481 TZ10H009

Manufacturer

Dicloran,Tablet

Sildenafil Citrate IH

3,480 TAN 10,048 J02A UNI

Shelf life
month

Unique Pharmaceutical
Laboratories Ltd.( A Div of
J.B. Chemicals and
Pharmaceuticals Ltd.)
INDIA

Unison Laboratories Company Ltd. - THAILAND


Cetihis,Tablet

Cetrizine Dihydrochloride
BP

Page 554 of 584

10 mg

24

Unison Laboratories
Company Ltd.
THAILAND

Human Medicinal Products


S/No:

Registration Number

3,483 TAN 05,544 J01D UNI

3,484 TAN 05,545 J01F UNI

3,485 TAN 05,705 D01B UNI

3,486 TAN 05,704 J01D UNI

3,487 TAN 05,703 J01D UNI

Registrant
3,488 TAN 07,416 D01A UNI

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Fontax,Injection

Cefotaxime Sodium USP

1g

24

Roxithromycin BP

300 mg

24

Itraconazole IH

100 mg

24

Ceftriaxone Sodium USP

1g

30

Cefuroxime Sodium USP

750 mg

24

Unison Laboratories
Company Ltd.
THAILAND

Uonin,Tablet
Unison Laboratories
Company Ltd.
THAILAND

Itracon,Capsules
Unison Laboratories
Company Ltd.
THAILAND

Triacef,Powder for Injection


Unison Laboratories
Company Ltd.
THAILAND

Zonef,Injection
Unison Laboratories
Company Ltd.
THAILAND

Universal Corporation Ltd. - KENYA


Clotrine,Cream

Clotrimazole USP

Page 555 of 584

1 %w/w

24

Universal Corporation Ltd.


KENYA

Human Medicinal Products


S/No:

Registration Number

3,489 TAN 07,417 J03B UNI

3,490 TAN 07,418 M01A UNI

3,491 TAN 10, 048 J02A UNI

3,492 TAN 10,074 J02A

Registrant
3,493 TAN 00,2432 N01B VIT

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Sulfrin Paediatric,Suspension

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

24

Universal Corporation Ltd.


KENYA

Diclofenac Sodium BP

50 mg

24

Universal Corporation Ltd.


KENYA

Fluconazole BP

200 mg

36

University Of Dar es salaam


TANZANIA

Fluconazole BP

150 mg

36

Universal Corporation Ltd.


KENYA

36

Vital Healthcare Pvt Ltd.


INDIA

36

Vital Healthcare Pvt Ltd.


INDIA

Dinac,Tablet

Flutrox,Capsules

Flutrox,Capsules

Vital Healthcare Pvt Ltd. - INDIA


Lignocaine,Injectable
Solution

lignocaine hydrochloride IH 20 mg

3,494 TAN 00,2431 P01B VIT

Shelf life
month

Quinine
Dihydrochloride,Injectable
Quinine Dihydrochloride
Solution

BP

Page 556 of 584

300 mg/ml

Human Medicinal Products


S/No:

Registration Number

3,495 TAN 05,212 J01K VIT

3,496 TAN 05,548 A03B VIT

3,497 TAN 05,549 N01A VIT

3,498 TAN 05,553 N01B VIT

3,499 TAN 05,550 H02A VIT

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,501 TAN 05,551 N01A VIT

Manufacturer

Tobravit,Ophthalmic Solution

Tobramycin Sulphate USP

0.3 %

24

Vital Healthcare Pvt Ltd.


INDIA

Atropine Sulphate BP

0.5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Ketamine Hydrochloride BP 50 mg

36

Vital Healthcare Pvt Ltd.


INDIA

Bupivaine Hydrochloride BP 5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

36

Vital Healthcare Pvt Ltd.


INDIA

Tramadol Hydrochloride IH 50 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Pancuronium Bromide BP

36

Vital Healthcare Pvt Ltd.


INDIA

Atropine,Solution

Ketavit-50,Solution

Bupivit,Solution

Prednivita,Suspension

Predinisolone Acetate USP

3,500 TAN 05,547 N02B VIT

Shelf life
month

10 mg/5ml

Tramol,Solution

Panumed,Solution

Page 557 of 584

2 mg/ml

Human Medicinal Products


S/No:

Registration Number

3,502 TAN 05,552 N05B VIT

Product Name
Pack and Pack size

Ingredient(s) and Strength

36

Vital Healthcare Pvt Ltd.


INDIA

5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

7.5 %

36

Vital Healthcare Pvt Ltd.


INDIA

50 mg/ml

24

Vital Healthcare Pvt Ltd.


INDIA

1g

36

Astra Pharma(T) Ltd.


TANZANIA

100 mg

36

Vital Healthcare Pvt Ltd.


INDIA

Calmvita,Injectable Solution

Diazepam BP

3,504 TAN 05,708 A02A VIT

Sodavita-L,Solution

Sodium Bicarbonate BP

3,505 TAN 05,707 V07A VIT

Neurovit,Injectable Solution

Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Hydrochloride BP
Nicotinamide BP
Cyanocobalamin BP
D-Panthenol USP
3,506 TAN 06,217 N01A VIT

50 mg/ml
50 mg/ml
500 mcg/ml
25 mg/ml

Thiovita H,Injectable Solution

Thiopentone Sodium BP

3,507 TAN 06,215 H02A VIT

Manufacturer

Fluvita,Solution

Fluphenazine Decanoate BP 25 mg/ml

3,503 TAN 05,706 N04C VIT

Shelf life
month

Vitacort-NS,Powder for
Injection

Hydrocortisone Sodium
Succinate equivalent to
Hydrocortisone BP

Page 558 of 584

Human Medicinal Products


S/No:

Registration Number

3,508 TAN 06,216 D01A VIT

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,510 TAN 06,468 B03A VIT

3,511 TAN 07,241 J01A VIT

1 %w/w

36

Vital Healthcare Pvt Ltd.


INDIA

Chloramphenicol BP

1 %w/w

36

Vital Healthcare Pvt Ltd.


INDIA

Iron Dextran IH

50 mg/ml

60

Vital Healthcare Pvt Ltd.


INDIA

1%

36

Vital Healthcare Pvt Ltd.


INDIA

5 mg

24

Vital Healthcare Pvt Ltd.


INDIA

36

Vital Healthcare Pvt Ltd.


INDIA

Chlorvita,Eye Ointment

Ferodexo,Solution

Oxyvita,Eye Ointment

Oxytetracycline
Hydrochloride BP

3,512 TAN 00,2065 A11B VIT

Vitamin B Complex,Injectable
Solution

Riboflavine Sodium
Phosphate BP
Thiamine Hydrochloride BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
D-Panthenol USP

3,513 TAN 00,2066 N02B VIT

Manufacturer

Clotrimazole,Cream

Clotrimazole BP

3,509 TAN 06,218 J01B VIT

Shelf life
month

Diclofenac Sodium,Injectable
Solution

Diclofenac Sodium USP

Page 559 of 584

100 mg
100 mg
10 mg
10 mg

25 mg/ml

Human Medicinal Products


S/No:

Registration Number

3,514 TAN 07,419 V07A VIT

Product Name
Pack and Pack size

Ingredient(s) and Strength

24

Vital Healthcare Pvt Ltd.


INDIA

36

Vital Healthcare Pvt Ltd.


INDIA

10 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Aminophylline BP

25 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Atropine Sulphate BP

0.5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Atropine Sulphate BP

0.5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

100 mg
10 mg/ml
2 mg
2 mg/ml
5 mg

Lignocaine,Injectable
Solution

lignocaine hydrochloride IH 20 mg

3,516 TAN 07,603 J01G VIT

Gentovit,Injectable Solution

Gentamycin Sulphate BP

3,517 TAN 00,2429 R03A VIT

3,518 TAN 05,548 A03B VIT

3,519 TAN 05,548 A03B VIT

Manufacturer

Bikovit,Solution

Niacinamide BP
Thiamine Hydrochloride BP
Riboflavin Sodium
Phosphate BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
D-Panthenol USP
3,515 TAN 00,2432 N01B VIT

Shelf life
month

Vitaphylline,Injectable
Solution

Atropine,Solution

Atropine,Solution

Page 560 of 584

Human Medicinal Products


S/No:

Registration Number

3,520 TAN 05,549 N01A VIT

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,522 TAN 05,553 N01B VIT

3,523 TAN 05,553 N01B VIT

3,524 TAN 05,550 H02A VIT

36

Vital Healthcare Pvt Ltd.


INDIA

Ketamine Hydrochloride BP 50 mg

36

Vital Healthcare Pvt Ltd.


INDIA

Bupivaine Hydrochloride BP 5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Bupivaine Hydrochloride BP 5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

10 mg/5ml

36

Vital Healthcare Pvt Ltd.


INDIA

10 mg/5ml

36

Vital Healthcare Pvt Ltd.


INDIA

36

Vital Healthcare Pvt Ltd.


INDIA

Ketavit-50,Solution

Bupivit,Solution

Bupivit,Solution

Prednivita,Suspension

Predinisolone Acetate USP

3,525 TAN 05,550 H02A VIT

Prednivita,Suspension

Predinisolone Acetate USP

3,526 TAN 05,547 N02B VIT

Manufacturer

Ketavit-50,Solution

Ketamine Hydrochloride BP 50 mg

3,521 TAN 05,549 N01A VIT

Shelf life
month

Tramol,Solution

Tramadol Hydrochloride IH 50 mg/ml

Page 561 of 584

Human Medicinal Products


S/No:

Registration Number

3,527 TAN 05,547 N02B VIT

3,528 TAN 05,552 N05B VIT

3,529 TAN 05,552 N05B VIT

3,530 TAN 05,551 N01A VIT

3,531 TAN 05,706 N04C VIT

Product Name
Pack and Pack size

Ingredient(s) and Strength

Tramadol Hydrochloride IH 50 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Fluphenazine Decanoate BP 25 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Fluphenazine Decanoate BP 25 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

Pancuronium Bromide BP

2 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

5 mg/ml

36

Vital Healthcare Pvt Ltd.


INDIA

7.5 %

36

Vital Healthcare Pvt Ltd.


INDIA

Fluvita,Solution

Fluvita,Solution

Panumed,Solution

Calmvita,Injectable Solution

Calmvita,Injectable Solution

Diazepam BP

3,533 TAN 05,708 A02A VIT

Manufacturer

Tramol,Solution

Diazepam BP

3,532 TAN 05,706 N04C VIT

Shelf life
month

Sodavita-L,Solution

Sodium Bicarbonate BP

Page 562 of 584

Human Medicinal Products


S/No:

Registration Number

3,534 TAN 05,708 A02A VIT

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,537 TAN 05,062 D08A WAR

Registrant

Vital Healthcare Pvt Ltd.


INDIA

50 mg/ml

24

Vital Healthcare Pvt Ltd.


INDIA

24

Vital Healthcare Pvt Ltd.


INDIA

50 mg/ml
50 mg/ml
500 mcg/ml
25 mg/ml

50 mg/ml
50 mg/ml
50 mg/ml
500 mcg/ml
25 mg/ml

Warner-Lambert S.A (Pty) Ltd. - SOUTH AFRICA


Cool Mint Listerine,Solution

Alcohol IH
Thymol USP

3,538 TAN 00,932 R05A WAR

36

Neurovit,Injectable Solution

Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Hydrochloride BP
Nicotinamide BP
Cyanocobalamin BP
D-Panthenol USP

Registrant

7.5 %

Neurovit,Injectable Solution

Pyridoxine Hydrochloride
Ascorbic Acid BP
Thiamine Hydrochloride BP
Nicotinamide BP
Cyanocobalamin BP
D-Panthenol USP
3,536 TAN 05,707 V07A VIT

Manufacturer

Sodavita-L,Solution

Sodium Bicarbonate BP

3,535 TAN 05,707 V07A VIT

Shelf life
month

SINUTAB WITH
CODEINE,Tablet

4.531 mg/20ml
12.78 mg/20ml

15 mg
Codeine BP
Phenyltoloxamine Citrate IH 22 mg
Phenylpropanolamine
25 mg
Hydrochloride USP
300 mg
Paracetamol USP

Whitehall South Africa - SOUTH AFRICA

Page 563 of 584

24

24

Warner-Lambert S.A (Pty)


Ltd.
SOUTH AFRICA

Warner-Lambert S.A (Pty)


Ltd.
SOUTH AFRICA

Human Medicinal Products


S/No:

Registration Number

3,539 TAN 00,387 R05A WHI

3,540 TAN 00,387 R05A WHI

Registrant
3,541 TAN 00,4177 N02A WIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Ibuprofen USP
Pseudoephedrine
Hydrochloride USP

200 mg
30 mg

36

Wyeth lederle SpA


ITALY

Ibuprofen USP
Pseudoephedrine
Hydrochloride USP

200 mg
30 mg

36

Wyeth lederle SpA


ITALY

24

Windlas Biotech Ltd.


INDIA

36

Windlas Biotech Ltd.


INDIA

Dried Aluminium Hydroxide 120 mg


BP
Magnesium Trisilicate BP 250 mg

24

Windlas Biotech Ltd.


INDIA

Albendazole BP

24

Windlas Biotech Ltd.


INDIA

Advil Cs,Tablet

Windlas Biotech Ltd. - INDIA


Pantra,Solution

Erythromycin,Tablet

Erythromycin Stearate eq to 250 mg


Erythromycin USP

3,543 TAN 05,120 A02A MER

3,544 TAN 05,187 A02C MER

Manufacturer

Advil Cs,Tablet

Tramadol Hydrochloride BP 100 mg/2ml

3,542 TAN 05,119 J01F MER

Shelf life
month

Compound Magnesium
Trisilicate,Tablet

Alom,Suspension

Page 564 of 584

200 mg/5ml

Human Medicinal Products


S/No:

Registration Number

3,545 TAN 05,213 R05A WIN

3,546 TAN 05,554 B03A WIN

Registrant
3,547 TAN 00,4579 G04B WIN

3,548 TAN 00,4522 C01E WIN

3,549 TAN 00,4521 C01E WIN

3,550 TAN 05,818 J02A WIN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Brogus,Syrup
24

Windlas Biotech Ltd.


INDIA

50 mg

36

Windlas Biotech Ltd.


INDIA

L-Ornithine L-aspartate BP
Riboflavine Sodium BP
Nicotinamide BP

240 mg/5ml
0.84 mg/5ml
24 mg/5ml

18

Win-Medicare Private Ltd.


INDIA

Ramipril BP

5 mg

24

Win-Medicare Ltd.
INDIA

Ramipril BP

2.5 mg

24

Win-Medicare Ltd.
INDIA

200 mg

36

Win-Medicare Ltd.
INDIA

Bromhexine Hydrochloride
BP
Salbutamol Sulphate
equivalent to Salbutamol BP
Guiafenesin BP
Menthol IH

4 mg/10ml

Ferric Hydroxide
Polymaltose Complex IH

2 mg/10ml
100 mg/10ml
1 mg/10ml

Trufer,Syrup

Win-Medicare Private Ltd. - INDIA


Hepa Merz,Syrup

Variace,Capsules

Variace,Capsules

Logican 200,Capsules

Fluconazole IH

Page 565 of 584

Human Medicinal Products


S/No:

Registration Number

3,551 TAN 08,122 N02B WIN

3,552 TAN 00,1918 G04A WIN

3,553 B663/2007/1

3,554 TZ11H012

Registrant
3,555 TAN 05,142 A02A AVE

Product Name
Pack and Pack size

Ingredient(s) and Strength

Manufacturer

Urgendol,Capsules

Tramadol Hydrochloride BP 50 mg

36

Win-Medicare Private Ltd.


INDIA

Ursodeoxycholic Acid BP

150 mg

24

Win-Medicare Ltd.
INDIA

Lansoprazole IH

30 mg

24

Win-Medicare Ltd.
INDIA

Paracetamol BP
Chlorzoxazone USP

500 mg
250 mg

36

Win-Medicare Ltd.
INDIA

24

Sanofi-Aventis S.p.A
ITALY

Udihep,Tablet

Zapacid,Capsules

Myospaz,Tablet

Winthrop compony - SOUTH AFRICA


Maalox Plus,Tablet

Magnesium Hydroxide Ph
Eur
Simethicone USP
Aluminium Hydroxide wet
gel equivalent to dried
Aluminium Hydroxide gel
USP/EP

Registrant

Shelf life
month

Wockhardt Ltd. - INDIA

Page 566 of 584

200 mg
25 mg
200 mg/ml

Human Medicinal Products


S/No:

Registration Number

3,556 TAN 00,940 J01F WOC

3,557 TAN 05,063 J01K WOC

3,558 TAN 05,555 B06A WOC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Azithromycin Dihydrate
equivalent to Azithromycin
BP

250 mg

36

Wochardt Biotech Park


INDIA

Nadifloxacin IH

100 mg/10g

24

Wockhardt Ltd.
INDIA

24

Gland Pharma Ltd


INDIA

24

Gland Pharma Ltd


INDIA

100 IU/ml

24

Wockhardt Ltd.
INDIA

100 IU/ml

24

Wockhardt Ltd.
INDIA

100 IU/ml

24

Wockhardt Ltd.
INDIA

Nadoxin,Cream

Wepox,Injectable Solution

Wepox,Injectable Solution

Recombinant human
2200 IU/0.5ml
erythropoietin concentrated
solution IH
3,560 TAN 05,557 A10A WOC

Wosulin-50/50,Injection

Biphasic Isophane Insulin


USP

3,561 TAN 05,558 A10A WOC

Wosulin-R,Injection

Human Insulin USP

3,562 TAN 05,559 A10A WOC

Manufacturer

Aziwok,Capsules

Recombinant human
2200 IU/0.5ml
erythropoietin concentrated
solution IH
3,559 TAN 05,556 B06A WOC

Shelf life
month

Wosulin-N,Injection

Human Insulin USP

Page 567 of 584

Human Medicinal Products


S/No:

Registration Number

3,563 TAN 00,010 R05D WOC

3,564 TAN 00,940 J01F WOC

3,565 TAN 05,710 J07A WOC

Product Name
Pack and Pack size

Ingredient(s) and Strength

24

Wockhardt Ltd.
INDIA

36

Wochardt Biotech Park


INDIA

24

Wockhardt Ltd.
INDIA

24

Wockhardt Ltd.
INDIA

100 IU/ml

24

Wockhardt Ltd.
INDIA

Isophane Insulin USP

100 IU/ml

24

Wockhardt Ltd.
INDIA

Cefuroxime Axetil
equivalent to Cefuroxime
USP

125 mg/5ml

18

Wockhardt Biotech Park


INDIA

Bromhexine Hydrochloride
BP
Guaiphenesin BP
Menthol BP
Terbutaline Sulphate BP

8 mg

Azithromycin Dihydrate
equivalent to Azithromycin
BP

250 mg

100 mg
5 mg
2.5 mg

Aziwok,Capsules

Biovac B,Injectable Solution

Biovac B,Injectable Solution

Hepatitis B Surface antigen 20 mcg


protein Ph Eur

3,567 TAN 06,114 A10A WOC

Wosulin-30/70,Injection

Biphasic Isophane Insulin


USP

3,568 TAN 07,420 A10A WOC

3,569 TAN 00,2416 J01D WOC

Manufacturer

Bro zedex,Syrup

Hepatitis B Surface antigen 0.025 ml


protein Ph Eur

3,566 TAN 05,712 J07A WOC

Shelf life
month

Wosulin-N,Injectable
suspension

Kefstar,Suspension

Page 568 of 584

Human Medicinal Products


S/No:

Registration Number

3,570 TAN 09,036 A10A WOC

Product Name
Pack and Pack size

Ingredient(s) and Strength

Wosulin-30/70,Injectable
Solution

3,572 TAN 00,010 R05D WOC

3,573 TAN 05,063 J01K WOC

3,574 TAN 05,063 J01K WOC

3,575 TZ11H176

24

Wochardt Biotech Park


INDIA

Human Insulin
(Recombinant DNA origin)
USP

4 mg/ml

24

Wochardt Biotech Park


INDIA

Bromhexine Hydrochloride
BP
Guaiphenesin BP
Menthol BP
Terbutaline Sulphate BP

8 mg

24

Wockhardt Ltd.
INDIA

Nadifloxacin IH

100 mg/10g

24

Wockhardt Ltd.
INDIA

Nadifloxacin IH

100 mg/10g

24

Wockhardt Ltd.
INDIA

4000 IU/0.4ml

24

Wockhardt Biotech Park


INDIA

Wosulin-N,Injectable Solution

Bro zedex,Syrup

100 mg
5 mg
2.5 mg

Nadoxin,Cream

Nadoxin,Cream

Wepox 4000,Injection

Erythropoietin IH

Registrant

Manufacturer

4 mg/ml

Human Insulin
(Recombinant DNA origin)
USP

3,571 TAN 09,035 A10A WOC

Shelf life
month

Wockhardt UK Ltd. - UNITED KINGDOM

Page 569 of 584

Human Medicinal Products


S/No:

Registration Number

3,576 TAN 05,072 A04A CP

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,578 TAN 05,071 L01C CP

3,579 TAN 00,660 H02A CPP

10 mg

24

CP Pharmaceuticals Ltd
UNITED KINGDOM

Domperidone Maleate Ph
Eur

10 mg

24

CP Pharmaceuticals Ltd
UNITED KINGDOM

Tamoxifen Citrate BP

20 mg

24

CP Pharmaceuticals Ltd
UNITED KINGDOM

5 mg

24

CP Pharmaceuticals Ltd
UNITED KINGDOM

Domperidone,Tablet

Tamoxifen,Tablet

Prednisolone,Tablet

Prednisolone Ph Eur

Registrant
3,580 TAN 00,396 A11A WHI

Manufacturer

Domperidone,Tablet

Domperidone Maleate Ph
Eur

3,577 TAN 05,072 A04A CP

Shelf life
month

Wyeth South Africa (Pty) Ltd. - SOUTH AFRICA


Centrum,Tablet

Page 570 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

Beta Carotene Ph Eur


Silicon Dioxide Ph Eur
Biotin IH
Selenium IH
Thiamine Hydrochloride IH
Copper Oxide IH
Vitamin A IH
Cholecalciferol IH
Pyridoxine Hydrochloride
Ascorbic Acid IH
Cyanocobalamine IH
Riboflavin IH
Molybdenum Sodium IH
Iron USP
Zinc USP
Folic Acid USP
Calcium USP
Chromium USP
Niacin USP
Phosphorous USP
Pantothenic Acid USP
Potassium USP
Tocopheryl Acetate
Nicotinamide
Dexapanthenol USP
Chloride USP
Potasium Iodide USP
Manganese Sulphate

2000 IU
2 mcg
0.15 mg
25 mcg
1.4 mg
1 mg
2000 IU
200 IU
2 mg

Shelf life
month

Manufacturer

24

Wyeth Canada
CANADA

24

Wyeth Manufacturing (UK).


UNITED KINGDOM

1 mcg
1.6 mg
25 mcg
4 mg
5 mg
200 mcg
162 mg
25 mcg
18 mg
125 mg
6 mg
40 mg
14.9 mg

36.3 mg
100 mcg
1 mg

Sulphate Monohydrate USP


Magnesium Sulphate USP 100 mg
60 mg
Ascorbic Acid USP
3,581 TAN 09,240 C05A WYE

Preparation H,Suppositories

Yeast cells extract IH

Page 571 of 584

NA N/A

Human Medicinal Products


S/No:

Registration Number

Registrant
3,582 TAN 00,1295 J01H ZNU

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,583 F444

Penizen,Powder for Injection

3,585 F340

3,586 F341

3,587 F342

2400000 IU

36

Alembic Ltd
INDIA

Zenufa Laboratories (T) Ltd - TANZANIA


Indozen,Capsules

Indomethacin BP

3,584 F689

Manufacturer

Zenufa Laboratories Ltd. - TANZANIA


Benzathine Penicillin BP

Registrant

Shelf life
month

25 mg

24
Month
s

Zenufa Laboratories (T) Ltd


TANZANIA

Erythrozen,Tablet

Erythromycin Stearate eq to 250 mg


Erythromycin BP

24

Zenufa Laboratories (T) Ltd


TANZANIA

Tetracycline BP
Tetracycline Hydrochloride
BP

250 mg
250 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Sulfamethoxazole BP
Trimethoprim BP

400 mg
80 mg

24

Zenufa Laboratories SPRL


Congo

Acetylsalicylic Acid BP

300 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Tetrazen,Capsules

Zentrim,Tablet

Zenaspirin,Tablet

Page 572 of 584

Human Medicinal Products


S/No:

Registration Number

3,588 F399

Product Name
Pack and Pack size

Ingredient(s) and Strength

50 mg

3,591 TAN 08,162 A16A ZEN

3,592 F689

24

Zenufa Laboratories (T) Ltd


TANZANIA

24

Zenufa Laboratories (T) Ltd


TANZANIA

50 mg/5ml

Salbuzen,Syrup

Salbutamol Sulphate eq
4.82 mg/5ml
Salbutamol BP
Salbutamol Sulphate
2 mg/5ml
equivalent to Salbutamol BP
3,590 TAN 08,163 R02A ZEN

Manufacturer

Quinizen,Syrup

Quinine Bisulphate eq
Quinine BP
Quinine Bisulphate
equivalent to Quinine BP
3,589 F400

Shelf life
month

Zenkof Tablets,Tablet

Anise Oil BP
Eucalyptus Oil BP
Menthol BP
Peppermint oil BP
Creosote BP
Pumilio Pine Oil BP
Oleoresin Capsicum BP
Glycerrhiza glabra BP

0.001 ml
0.002 ml
10 mg
0.001 ml
0.002 ml
0.001 ml
0.064 mg
35 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Thiamine Hydrochloride BP
Ascorbic Acid BP
Vitamin A BP
Riboflavine Phosphate BP
Cholecalciferol BP
D-Panthenol BP
Cyanocobalamin BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP

2 mg/5ml
50 mg/5ml
2500 IU/5ml
1 mg/5ml
200 IU/5ml
2.5 mg/5ml
1 mcg/5ml
15 mg/5ml
1 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

24

Zenufa Laboratories (T) Ltd


TANZANIA

Dayvit,Syrup

Erythrozen,Tablet

Erythromycin Stearate eq to 250 mg


Erythromycin BP

Page 573 of 584

Human Medicinal Products


S/No:

Registration Number

3,593 F373

3,594 F374

3,595 F375

3,596 F432

3,597 F433

3,598 F434

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Zenogyl,Suspension

Metronidazole Benzoate BP 200 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Chlorpheniramine Maleate
BP

2 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Bromhexine Hydrochloride
BP
Chloropheniramine BP
Dextromethorphan
Hydrobromide BP
Ammonium Chloride BP
Chlorpheniramine Maleate
BP

4 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Cloxacillin Sodium BP
Ampicillin Trihydrate BP
Cloxacillin Sodium
equivalent to Cloxacillin BP
Ampicillin Trihydrate
equivalent to Ampicillin BP

250 mg
250 mg
250 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Pirizen,Syrup

Zentuss,Syrup

2 mg/5ml
5 mg
50 mg
2 mg

MP-Clox,Capsules

250 mg

Zentrim,Suspension

Sulfamethoxazole BP
Trimethoprim BP

200 mg/5ml
40 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Ampicillin Sodium BP

250 mg

36

Zenufa Laboratories (T) Ltd


TANZANIA

Ampizen,Capsules

Page 574 of 584

Human Medicinal Products


S/No:

Registration Number

3,599 F435

3,600 F339

3,601 F441

3,602 F442

3,603 F372

3,604 F385

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Zenoxyl,Capsules

Amoxicillin Trihydrate
250 mg
equivalent to Amoxicillin BP

24

Zenufa Laboratories (T) Ltd


TANZANIA

273.6 mg
Cloxacillin Sodium BP
Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP

24

Zenufa Laboratories (T) Ltd


TANZANIA

Amoxicillin Trihydrate
125 mg/5ml
equivalent to Amoxicillin BP

24

Zenufa Laboratories (T) Ltd


TANZANIA

Cloxazen,Capsules

Zenoxyl,Powder for
Suspension

Ampizen,Powder for
Suspension

Ampicilin Trihydrate BP
Ampicillin Trihydrate BP

125 mg/5ml
125 mg/5ml

36

Zenufa Laboratories (T) Ltd


TANZANIA

Paracetamol BP

120 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Caffeine BP
Paracetamol BP
Chlorpheniramine BP
Phenylephrine BP
Phenylephrine
Hydrochloride BP
Chlorpheniramine Maleate
BP
Caffeine Anhydrous BP

30 mg
500 mg
2.0 mg
5.0 mg
5 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Zenadol,Solution

Dr Cold,Tablet

Page 575 of 584

2 mg
30 mg

Human Medicinal Products


S/No:

Registration Number

3,605 F404

3,606 F384

3,607 TAN 07,628 A16A ZEN

3,608 TAN 08,125 A03D ZEN

3,609 TAN 08,124 R02A ZEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Zenkof,Syrup

Chloropheniramine BP
Ammonium Chloride BP
Chlorpheniramine Maleate
BP

2 mg/5ml
110 mg/5ml
2 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Metronidazole BP

200 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Thiamine Hydrochloride BP
Ascorbic Acid BP
Vitamin A BP
Riboflavine Phosphate BP
Cholecalciferol BP
Cyanocobalamin BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP

1.5 mg/5ml
10 mg/5ml
3000 IU/5ml
0.5 mg/5ml
400 IU/5ml
2 mcg/5ml
10 mg/5ml
1 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Liquorice Liquid Extract BP


Ammonium Chloride BP
Ammonium Bicarbonate BP
Chloroform Et Morphine BP
Chloroform and Mophine
tincture BP

0.25 ml/5ml
150 mg/5ml
100 mg/5ml
0.15 ml
0.15 ml/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Bromhexine Hydrochloride
BP
Guaiphenesin BP
Menthol BP
Terbutaline Sulphate BP

4 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Zenogyl,Tablets

Zenergy Syrup,Syrup

Mes,Syrup

Brozen,Syrup

Page 576 of 584

2.5 mg/5ml
2.5 mg/5ml
1.25 mg/5ml

Human Medicinal Products


S/No:

Registration Number

3,610 TAN 08,123 R02A ZEN

3,611 TAN 09,078 P02X ZEN

3,612 TAN 09,079 J01C ZEN

3,613 TAN 09,250 R06A ZEN

3,614 TAN 09,253 A11E ZEN

3,615 TAN 09,246 J01H ZEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Trimol,Syrup
24

Zenufa Laboratories (T) Ltd


TANZANIA

100 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Ampicillin Trihydrate BP
Cloxacillin Sodium BP

125 mg/5ml
125 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Chlorpheniramine Maleate
BP

4 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Thiamine Hydrochloride BP
Riboflavine Phosphate BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP

5 mg/5ml
2 mg/5ml
20 mg/5ml
2 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

125 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Chlorpheniramine Maleate
BP
Theophyline BP
Menthol BP
Paracetamol BP
Sodium Citrate BP
Ammonium Chloride BP

2 mg/5ml

Mebendazole USP

50 mg/5ml
1.1 mg/5ml
120 mg/5ml
50 mg/5ml
110 mg/5ml

Mebenda Z,Tablet

MP-Clox,Syrup

Pirizen,Tablet

Zen B Plex,Syrup

Penizen - V,Powder for


Suspension

Phenoxymethyl Penicillin
Potassium BP

Page 577 of 584

Human Medicinal Products


S/No:

Registration Number

3,616 TAN 09,245 J01F ZEN

3,617 TAN 09,243 M01A ZEN

3,618 TAN 09,242 P01B ZEN

3,619 TAN 09,247 A11E ZEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,621 TAN 09,255 H02A ZEN

Manufacturer

Erythrozen,Syrup

Erythromycin Estolate BP

125 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Diclofenac Sodium BP

50 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Quinine Sulphate BP

300 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

16.5mg mg
1.1 mg
1.1 mg
1 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Ziclofen,Tablet

Quinizen,Tablet

Zen - B - Plex,Tablet

Nicotinamide BP
Riboflavine Sodium BP
Thiamine HCl (B1) BP
Riboflavine Sodium
Phosphate BP
Thiamine Hydrochloride BP
3,620 TAN 09,266 P02X ZEN

Shelf life
month

1 mg

Mebenda Z,Suspension

Mebendazole BP

100 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Prednisolone BP

5 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Prednizen,Tablet

Page 578 of 584

Human Medicinal Products


S/No:

Registration Number

3,622 TAN 09,255 H02A ZEN

3,623 F891

3,624 F892

3,625 F893

3,626 F916

3,627 F918

3,628 F919

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Prednizen,Tablet

Prednisolone BP

5 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Ibuprofen BP
Paracetamol BP

100 mg/5ml
125 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Levamisole Hydrochloride
USP

40 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Ibuprofen BP

200 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Levamisole BP

40 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Amoxicillin Trihydrate
500 mg
equivalent to Amoxicillin BP

24

Zenufa Laboratories (T) Ltd


TANZANIA

Paracetamol BP
Diclofenac BP
Chlorzoxazone USP

24

Zenufa Laboratories (T) Ltd


TANZANIA

Termidol,Solution

Leva-Z,Tablet

Ibufen,Tablet

Leva-Z,Solution

Zenoxyl,Capsules

Muscle plus,Tablet

Page 579 of 584

500 mg
50 mg
250 mg

Human Medicinal Products


S/No:

Registration Number

3,629 TZ10H014

3,630 TAN 09,265 P01B ZEN

3,631 TAN 08,163 R02A ZEN

3,632 TAN 08,162 A16A ZEN

3,633 TZ10H015

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

MP-Clox,Capsules

Cloxacillin Sodium
250 mg
equivalent to Cloxacillin BP
Ampicillin Trihydrate
250 mg
equivalent to Ampicillin BP

36

Zenufa Laboratories (T) Ltd


TANZANIA

Amodiaquine Hydrochloride 261.25 mg


BP

24

Zenufa Laboratories (T) Ltd


TANZANIA

Malaridose,Tablet

Zenkof Tablets,Tablet

Anise Oil BP
Eucalyptus Oil BP
Menthol BP
Peppermint oil BP
Creosote BP
Pumilio Pine Oil BP
Oleoresin Capsicum BP
Glycerrhiza glabra BP

0.001 ml
0.002 ml
10 mg
0.001 ml
0.002 ml
0.001 ml
0.064 mg
35 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Thiamine Hydrochloride BP
Ascorbic Acid BP
Vitamin A BP
Riboflavine Phosphate BP
Cholecalciferol BP
D-Panthenol BP
Cyanocobalamin BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP

2 mg/5ml
50 mg/5ml
2500 IU/5ml
1 mg/5ml
200 IU/5ml
2.5 mg/5ml
1 mcg/5ml
15 mg/5ml
1 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Ampicillin Trihydrate BP
Ampicillin Sodium BP

288.7 mg
250 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Dayvit,Syrup

Ampizen,Capsules

Page 580 of 584

Human Medicinal Products


S/No:

Registration Number

3,634 TAN 07,628 A16A ZEN

3,635 TAN 09,250 R06A ZEN

3,636 TAN 09,241 J01K ZEN

3,637 TAN 09,248 J01H ZEN

3,638 TAN 09,253 A11E ZEN

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Zenergy Syrup,Syrup
24

Zenufa Laboratories (T) Ltd


TANZANIA

4 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Ciprofloxacin BP

500 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Phenoxymethyl Penicillin
Potassium BP

277.2 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Thiamine Hydrochloride BP
Ascorbic Acid BP
Cyanocobalamin (Vitamin
B12) BP
Riboflavin Sodium
Phosphate BP
Vitamin A acetate BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
Colecalciferol (Vit. D3) BP
Vitamin A BP
Riboflavine Phosphate BP
Cholecalciferol BP
Cyanocobalamin BP

1.65 mg/5ml
11 mg/5ml
0.025 mg

Chlorpheniramine Maleate
BP

0.8 mg
2.065 mg
11 mg/5ml
1.1 mg/5ml
0.02 mg
3000 IU/5ml
0.5 mg/5ml
400 IU/5ml
2 mcg/5ml

Pirizen,Tablet

Cipro - Z,Tablet

Penizen V,Tablet

Zen B Plex,Syrup

Page 581 of 584

Human Medicinal Products


S/No:

Registration Number

Product Name
Pack and Pack size

Ingredient(s) and Strength

3,640 TAN 09,245 J01F ZEN

3,641 TAN 09,244 R03A ZEN

3,642 TAN 09,243 M01A ZEN

3,643 TAN 09,242 P01B ZEN

3,644 TAN 09,266 P02X ZEN

Manufacturer

5.5 mg/5ml
3.25 mg/5ml
22 mg/5ml
2.2 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Phenoxymethyl Penicillin
Potassium BP

125 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Erythromycin Estolate BP

125 mg/5ml

24

Zenufa Laboratories (T) Ltd


TANZANIA

Salbutamol Sulphate
4 mg
equivalent to Salbutamol BP

24

Zenufa Laboratories (T) Ltd


TANZANIA

Diclofenac Sodium BP

50 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Quinine Sulphate BP

300 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

100 mg

24

Zenufa Laboratories (T) Ltd


TANZANIA

Thiamine Hydrochloride BP
Riboflavine Phosphate BP
Nicotinamide BP
Pyridoxine Hydrochloride
Ascorbic Acid BP
3,639 TAN 09,246 J01H ZEN

Shelf life
month

Penizen - V,Powder for


Suspension

Erythrozen,Syrup

Sulbuzen,Tablet

Ziclofen,Tablet

Quinizen,Tablet

Mebenda Z,Suspension

Mebendazole BP

Page 582 of 584

Human Medicinal Products


S/No:

Registration Number

Registrant
3,645 TAN 00,1005 V03A ZNU

3,646 TAN 00,1742 B05B ZNU

Registrant
3,647 TAN 06,227 D01A ZYG

3,648 TAN 06,226 D02A ZYG

3,649 TAN 06,225 D06B ZYG

3,650 TAN 06,224 D07A ZYG

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Zenufa Laboratories Group S.A - UNITED KINGDOM


Sodium Lactate,Solution

Sodium Chloride +
Glucose,Solution

Calcium Chloride BP
Sodium Lactate BP
Potassium Chloride BP

0.27 g/100ml
0.32 g/100ml
0.04 g/100ml

36

Albert David Ltd.


INDIA

Glucose Anhydrous BP
Sodium Chloride BP

5 %w/v
0.9 %w/v

60

Albert David Ltd.


INDIA

Benzoyl Peroxide BP

5 %w/w

24

ZYG Pharma Pvt Ltd


INDIA

Cetyl Alcohol BP
Stearyl Alcohol BP

27.03 mg/g
2.99 mg/g

24

ZYG Pharma Pvt Ltd


INDIA

Salicylic Acid USP


Coal tar USP

20 mg/g
42.5 mg/g

24

ZYG Pharma Pvt Ltd


INDIA

Clobetasol Propionate USP

0.5 mg

24

ZYG Pharma Pvt Ltd


INDIA

ZYG Pharma Pvt Ltd. - INDIA


Enzoxid 5,Gel

Sotil,Lotion

CTS,Solution

Quace,Cream

Page 583 of 584

Human Medicinal Products


S/No:

Registration Number

3,651 TAN 06,223 J01F ZYG

3,652 TAN 06,222 D07A ZYG

3,653 TAN 06,228 J05A ZYG

3,654 TAN 06,221 D01A ZYG

3,655 TAN 06,220 D01A ZYG

3,656 TAN 06,219 D01A ZYG

Grand Total:

Product Name
Pack and Pack size

Ingredient(s) and Strength

Shelf life
month

Manufacturer

Erazit,Gel

Erythromycin USP

44 mg

24

ZYG Pharma Pvt Ltd


INDIA

Betamethasone
Dipropionate USP

0.64 mg

24

ZYG Pharma Pvt Ltd


INDIA

Acyclovir BP

50 mg/g

24

ZYG Pharma Pvt Ltd


INDIA

Clotrimazole USP

10 mg/g

24

ZYG Pharma Pvt Ltd


INDIA

Benzoyl Peroxide BP

2.5 %w/w

24

ZYG Pharma Pvt Ltd


INDIA

Gentamicin Sulphate
equivalent to Gentamicin
USP
Clotrimazole USP

1 mg/g

24

ZYG Pharma Pvt Ltd


INDIA

Quall,Cream

Herpizyg,Cream

Butate,Cream

Enzoxid 2.5,Gel

Tolnys,Cream

3,656

Page 584 of 584

10 mg/g

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