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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 2 of 4

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Product Country Status

IOTIM

-

Botswana Registered/Compliant

Iobrim Eye Drop

Brimonidine Tartrate 0.2 IU/ml

Tanzania Registered/Compliant

Ioprost-T

Latanoprost 50 IU/ml,Timolol 5 mg/ mL

Tanzania Registered/Compliant

Iotim

Benzalkonium chloride IU/ml,Disodium E.D.T.A IU/ml,Disodium Hydrogen Phosphate Dihydrate IU/ml,Polyvinyl Alcohol IU/ml,Sodium Chloride IU/ml,Sodium Dihydrogen Phosphate Dihydrate IU/ml,Sodium Hydroxide mg/0.8 ML,Timolol Maleate 0.5 % w/v,Water for Injection mg/0.8 ML

Tanzania Registered/Compliant

Iotim 0.5 % w/v

Benzalkonium chloride IU/ml,Disodium E.D.T.A IU/ml,Disodium Hydrogen Phosphate Dihydrate IU/ml,Polyvinyl Alcohol IU/ml,Sodium Chloride IU/ml,Sodium Dihydrogen Phosphate Dihydrate IU/ml,Sodium Hydroxide mg/0.8 ML,Timolol Maleate 0.5 % w/v,Water for Injection mg/0.8 ML

Tanzania Registered/Compliant

Latanoprost Eye Drops

Latanoprost 0.005 IU/ml

Tanzania Registered/Compliant

Moisol

Hydroxy Propyl Methyl Cellulose 0.7 % w/v

Tanzania Registered/Compliant

Moisol Eye drops

Hydroxypropyl Methylcellulose 0.7% w/v

Zambia Registered/Compliant

Mosi

Moxifloxacin Hydrochloride 5 w/w

Tanzania Registered/Compliant

Mosi-D

Dexamethasone 1 mg/5.26ml,Moxifloxacin Hydrochloride 5 mg/5.26ml

Tanzania Registered/Compliant

NALIDIXIC ACID

NALIDIXIC ACID

Zimbabwe PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)

OCULARIDE-T EYE DROPS (Each ml contains Dorzolamide Hydrochloride/Timolol Maleate 20mg/6.8mg)

Dorzolamide Hydrochloride/Timolol Maleate

Ghana Valid

OLHOTEM 0.5% W/V EYE DROPS

-

Ghana 3 months to expiry

OLODIN

Olopatadine Hydrochloride 1 mg

Tanzania Registered/Compliant

ORAL REHYDRATION SALT

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE: SODIUM CITRATE

Zimbabwe HOUSEHOLD REMEDIES (H.R.)

ORAL REHYDRATION SALTS

sodium, potassium, chloride, glucose

Botswana Registered/Compliant

ORAL REHYDRATION SALTS

-

Botswana Registered/Compliant

ORAL REHYDRATION SALTS BP

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

Tanzania Registered/Compliant

ORAL REHYDRATION SALTS BP 20.5 g

Anhydrous Glucose 13.5 gram,Potassium Chloride 1.5 gram,Sodium Chloride BP. 2.6 gram,Trisodium Citrate Dihydrate 2.9 gram

Tanzania Registered/Compliant

OTHROPOST-T EYE DROPS (Each ml contains Latanoprost/ Timolol Maleate 50mcg/5mg)

-

Ghana Valid