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Marketing Authorisation Holder

Fdc

INDIA

61

Total Medicines

50

Active

8

Dosage Forms

6

Countries

Tanzania (28) Zambia (12) Botswana (9) Ghana (6) Zimbabwe (5) Rwanda (1)

Registration Status

Registered 50
Valid 5
HOUSEHOLD REMEDIES (H.R.) 2
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 2
3 months to expiry 1
PHARMACIST INITIATED MEDICINES, (P.I.M.) 1

Local Agents / Applicants

FDC Limited 39
MEDIX CARE (PTY) LTD PLOT... 9
FDC LIMITED 5
Asterisk Lifesciences (Gh)... 4
MEGA LIFESCIENCES... 1
Bliss GVS Pharma Limited, India 1

Registered Medicines

Showing 20 of 61 · Page 3 of 4

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Product Country Status

Ocudor

Dorzolamide Hydrochloride 2 IU/ml

Tanzania Registered/Compliant

Ocudor T

Dorzolamide Hydrochloride Equivalent to Dorzolamide 20 % w/w,Timolol Meleate equivalent to Timolol 5 % w/w

Tanzania Registered/Compliant

Ocudor T

Dorzolamide Hydrochloride Eq. to Dorzolamide 20.0 mg,Timolol Maleate Eq. to Timolol 5 mg

Zambia Registered/Compliant

Oral Rehydration Salts BP

Anhydrous Glucose 13.5 g,Potassium Chloride 1.5 g,Sodium Chloride 2.6 g,Sodium Citrate 2.9 g

Zambia Registered/Compliant

Pyricort Ear/Eye Drops

Benzalkonium chloride IU/ml,Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 0.1 % w/v,Disodium Edetate IU/ml,Disodium phosphate dodecahydrate IU/ml,Gentamycin Sulphate equivalent to Gemtamicin 0.3 % w/v,Sodium Dihydrogen Phosphate Dihydrate IU/ml

Tanzania Registered/Compliant

Pyricort Eye/Ear drops

Dexamethasone Sodium Phosphate 0.1% w/v,Gentamycin Sulphate 0.3% w/v

Zambia Registered/Compliant

Pyrimon Eye/Ear drops

Chloramphenicol 1% w/v,Dexamethasone 0.1% w/v

Zambia Registered/Compliant

Rapiduce

Lactulose Concetrate 3.35 g/5ml

Tanzania Registered/Compliant

Rapiduce Solution

Lactulose 3.35 gm/5ml

Zambia Registered/Compliant

Tearmax

Carmellose Sodium 5 mg

Tanzania Registered/Compliant

Timolol 0.5% eye drops

Timolol Maleate 0.5 w/w

Zambia Registered/Compliant

VANMYCETIN EYE DROPS

Chloramphenicol 0.5 % w/v

Tanzania Registered/Compliant

XIPRO EYE/EAR DROPS (Each drop contains Ciprofloxacin 0.3%)

Ciprofloxacin

Ghana Valid

XIPRO TABLETS (Each tablet contains Ciprofloxacin 500mg )

Ciprofloxacin

Ghana Valid

ZIORAL 20 DT

-

Botswana Registered/Compliant

Zathrin 500

Azithromycin Dihydrate USP 500 mg,Colour Lake Ponceau 4R 0.350 mg,Croscarmellose Sodium 20.0 mg,Hypromellose 5 cps 12.60 mg,Isopropyl Alcohol -- QS,Macrogols 400 2.350 mg,Magnesium Stearate 11.00 mg,Microcrystalline Cellulose (Grade 102) 80.0 mg,Microcrystalline cellulose 89 mg,Povidone K -30 (Kollidon 30) 8.0 mg,Purified Talc BP 1.287 mg,Purified Water -- QS,Purified Water -- q.s,Purified talc -- QS,Purified talc 15.0 mg,Sodium Starch Glycollate (Primogel) 15.0 mg,Sodium lauryl sulphate 2.0 mg,Titanium dioxide 1.413 mg

Tanzania Registered/Compliant

Zo

Ofloxacin 0.3 IU/ml

Tanzania Registered/Compliant

Zocon

Fluconazole 200 mg

Tanzania Registered/Compliant

Zocon

Calcium Hydrogen phosphate mg,Colloidal anhydrous silica mg,Fluconazole 150 mg,Magnesium Stearate mg,Maize starch mg,Methyl paraben mg,Ponceau 4R Supra mg,Propyl paraben mg,Purified Water mg,Purified talc mg,Sodium Glycolate Starch mg,Sodium lauryl sulphate mg

Tanzania Registered/Compliant

Zoxan Eye/Ear drops

Ciprofloxacin Hydrochloride 3 mg/ml

Zambia Registered/Compliant