Marketing Authorisation Holder

MYLAN LABORATORIES LIMITED

INDIA

GMP Certified

Prestige Tech Park,Platina-3, PRESTIGE TECH PARK, 7th to 12th, Kadubeesanahalli, Bengaluru, Bellandur Amanikere, Karnataka 560103, India

Bengaluru, India

Maps

411

Total Medicines

293

Active

Dosage Forms

Countries

Tanzania (87) Zimbabwe (84) Botswana (56) Kenya (44) Uganda (43) Zambia (41) Ghana (30) Rwanda (26)

Location

Prestige Tech Park,Platina-3, PRESTIGE TECH PARK, 7th to 12th, Kadubeesanahalli, Bengaluru, Bellandur Amanikere, Karnataka 560103, India

Open in OpenStreetMap approx.

Registration Status

Registered 293

PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 67

Valid 17

PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10) 15

3 months to expiry 13

Unknown 3

PHARMACIST INITIATED MEDICINES, (P.I.M.) 2

Retained 1

Dosage Forms

Tablets 53 TABLET, COATED; ORAL 38 Film Coated Tablet 24 ORAL SOLID ORDINARY FILM-COATED TABLETS 22 TABLET; ORAL 21 TABLET 20 ORAL SOLID ORDINARY TABLETS 15 TABLETS 12

Therapeutic Classes

GENERIC/BIOSIMILARS 33

NEW/INNOVATOR 7

Local Agents / Applicants

MYLAN LABORATORIES LIMITED 149

Mylan Laboratories Limited 124

MYLAN LABORATORIES LIMITED... 55

MYLAN LABORATORIES LIMITED [OTL] 15

Worldwide Healthcare... 13

Worldwide Healthcare... 9

Distributing Wholesalers

Licensed wholesalers / distributors that carry this MAH's brands.

Harleys Pharmaceutical

Westlands, Nairobi

8 SKUs

Eastleigh Pharmaceutical

Eastleigh, Nairobi

7 SKUs

Generics Africa

Nairobi

2 SKUs

Browse all wholesalers

Registered Medicines

Showing 20 of 411 · Page 10 of 21

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Product	Form / Strength	Country	Reg. Number	Status
HEPBEST TABLETS (Each tablet contains Tenofovir Alafenamide 25mg) Tenofovir Alafenamide	Tenofovir Alafenamide 25mg	Ghana	FDA/SD.233-101132	Valid
HEPWIN TABLETS (Each tablet contains Entecavir monohydrate 0.5mg) Entecavir monohydrate	Entecavir monohydrate 0.5mg	Ghana	FDA/SD.243-030473	3 months to expiry
HEPWIN TABLETS (Each tablet contains Entecavir 1mg) Entecavir	- 1mg	Ghana	FDA/SD.243-060972	3 months to expiry
HERTRAZ 440 Trastuzumab 440 mg	Lyophilised powder for injection 440 mg	Zambia	014/055	Registered/Compliant
HepBest Tenofovir Alafenamide Fumarate 25mg	Film-Coated Tablets 25mg	Rwanda	Rwanda FDA-HMP-MA-0346	Registered
HepBest Tenofovir Alafenamide Fumarate 25 mg	Tablets	Tanzania	TAN 21 HM 0452	Registered/Compliant
Hyan FC Tablets Levonorgestrel Tablets	Tablet	Kenya	H2005/383/16732/R1	Retained
IRINOTECAN MYLAN IRINOTECAN HYDROCHLORIDE	SOLUTION; INFUSION 20 MG/ML	Zimbabwe	2023/9.4/6379	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
ISONAZID; PYRIDOXINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM ISONIAZID; PYRIDOXINE HYDROCHLORIDE; SULPHAMETHOXAZOLE; TRIMETHOPRIM	TABLET, COATED; ORAL 300; 25; 800; 160MG	Zimbabwe	2023/7.15/6484	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
ISONIAZID -	ORAL SOLID ORDINARY TABLETS 300MG	Uganda	NDA/MAL/HDP/6227	Registered
ISONIAZID ISONIAZID	TABLET; ORAL 300 MG	Zimbabwe	2016/7.3/5210	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
ISONIAZID TABLETS BP 300MG ISONIAZID	ISONIAZID 300MG	Kenya	H2020/CTD4546/1779ER	Registered
ISONIAZID/PYRIDOXINE HYDROCHLORIDE/ SULFAMETHOXAZOLE/ TRIMETHOPRIM Isoniazid 300mg	Tablet 300mg	Botswana	BOT2600073	Registered/Compliant
Isoniazid Isoniazid 300mg	Tablet Uncoated	Zambia	014/073	Registered/Compliant
Isoniazid Tablet BP Isoniazid 100 mg/0.8 ML	Tablets	Tanzania	TAN 20 HM 0538	Registered/Compliant
Isoniazid Tablets BP 300 mg Cellulose Microcrystalline 30.000 mg/6 mL,Croscarmellose Sodium 6.000 mg/6 mL,Isoniazid 300 mg,Mannitol 207.000 mg/6 mL,Povidone K30 15.000 mg/6 mL,Purified Water q.s q.s,Silica colloidal anhydrous Ph. Eur 3.000 mg/6 mL,Starch Pregelatinised 30.000 mg/6 mL,Stearic Acid 9.000 mg/6 mL	Oral tablet	Tanzania	TAN 23 HM 0297	Registered/Compliant
Isoniazid/Pyridoxine Hydrochloride/ Sulfamethoxazole/Trimethoprim tablets 300 mg/25 mg/800 mg/160 mg Colloidal silicon dioxide (Aerosil 200 pharma) 3.300 mg/6 mL,Docusate sodium 1.500 mg/6 mL,Hydroxy Propyl Cellulose 1.500 mg/6 mL,Hydroxy Propyl cellulose (Klucel LF) 27.000 mg/6 mL,Isoniazid 300 mg/6 mL,Low-substituted Hydroxy Propyl Cellulose 36.400 mg/6 mL,Magnesium Stearate 7.500 mg/6 mL,Microcrystalline Cellulose (Avicel PH101 32.60 mg/6 mL,Microcrystalline cellulose 41.900 mg/6 mL,Opadry Brown 03F86918 31.000 mg/6 mL,Partially pregelatinized maize starch (starch 1500) 24.850 mg/6 mL,Purified Water q.s q.s,Pyridoxine Hydrochloride 25 mg/6 mL,Sodium starch glycolate (Premajole) 11.200 mg/6 mL,Sodium starch glycolate (Premajole) 16.000 mg/6 mL,Stearic Acid 3.800 mg/6 mL,Sulfamethoxazole 800 mg/6 mL,Trimethoprim 160 mg/6 mL	Film Coated Tablet 300 MG / 25 MG / 800 MG / 160 MG	Tanzania	TAN 23 HM 0127	Registered/Compliant
Isoniazid/Pyridoxine hydrochloride/… Isoniazid Ph.Eur, Pyridoxine HCl Ph.Eur, …	Tablet	Kenya	None
KAVIDEZA ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE	TABLET, COATED; ORAL 600; 50; 300 MG	Zimbabwe	2025/7.13/7151	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
KAVIDEZA Abacavir Sulfate 600 mg,Colloidal Silicon Dioxide (Aerosil 200 Pharma) 18.500 mg/6 mL,Colloidal Silicon Dioxide (Aerosil 200). 10.000 mg/6 mL,Croscarmellose sodium (AcDiSol SD-711) 40.000 mg/6 mL,Dolutegravir Sodium 50 mg,Lamivudine 300 mg,Magnesium stearate, (Ligamed MF-2-V) 15.000 mg/6 mL,Magnesium stearate, (Ligamed MF-2-V) 3.000 mg/6 mL,Mannitol (Pearlitol 25C) 111.400 mg/6 mL,Mannitol (Pearlitol 25 C) USP-NF/Ph.Eur 40.000 mg/6 mL,Microcrystalline Cellulose (Avicel PH 101) USP-NF/Ph.Eur. 50.000 mg/6 mL,Microcrystalline cellulose (Avicel PH I02) 59.610 mg/6 mL,Microcrystalline cellulose (Ceolus UF 702) 47.500 mg/6 mL,Opadry Brown (85F565142) 47.100 mg/6 mL,Povidone (Kollidon 30) 15.000 mg/6 mL,Purified water® q.s q.s,Sodium Starch Glycolate (Primojel) 15.000 mg/6 mL,Sodium Starch Glycolate (Primojel) 30.000 mg/6 mL	Film coated tablets 300/50/60	Tanzania	TAN 26 HM 0563	Registered/Compliant

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411 products