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 8 of 21

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Product	Form / Strength	Country	Reg. Number	Status
EMFANEF TABLETS Efavirenz/ Emtricitabine/ Tenofovir Alafenamide	Efavirenz/ Emtricitabine/ Tenofovir Alafenamide 400mg/ 200mg/ 25mg	Ghana	FDA/SD.233-080982	3 months to expiry
EMTRICITABINE + TENOFOVIR ALAFENAMIDE FUMARATE -	ORAL SOLID ORDINARY FILM-COATED TABLETS 200 MG + 25 MG	Uganda	NDA/MAL/HDP/9269	Registered
EMTRICITABINE + TENOFOVIR ALAFENAMIDE FUMARATE + EFAVIRENZ -	ORAL SOLID ORDINARY FILM-COATED TABLETS 200 MG + 25 MG + 400 MG	Uganda	NDA/MAL/HDP/11794	Registered
EMTRICITABINE/TENOFOVIR -	ORAL SOLID ORDINARY FILM-COATED TABLETS 200MG/300MG	Uganda	NDA/MAL/HDP/5222	Registered
EMTRICITABINE/TENOFOVIR ALAFENAMIDE TABLETS 200 MG/25 MG EMTRICITABINE/ TENOFOVIR ALAFENAMIDE FUMARATE	EMTRICITABINE 200 MG/TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25 MG	Kenya	H2021/CTD7099/18179	Registered
EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLETS 200 MG/300 MG Emtricitabine/Tenofovir Disoproxil Fumarate, 200 mg/300 mg	Film-coated tablets 200 mg/300 mg	Rwanda	Rwanda FDA-HMP-MA-0724	Registered
EMTRICITABINE; TENOFOVIR ALAFENAMIDE EMTRICITABINE; TENOFOVIR ALAFENAMIDE	TABLET, COATED; ORAL 200; 25MG	Zimbabwe	2018/7.13/5740	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
ENVUTEG Dolutegravir Sodium 50 mg/6 mL,Lactose Monohydrate 60.000 mg/6 mL,Lamivudine 300 mg/6 mL,Magnesium Stearate 1.000 mg/6 mL,Magnesium Stearate 14.000 mg/6 mL,Mannitol (pearlitol 25C) 131.400 mg/6 mL,Microcrystalline Cellulose (Avicel PH101 60.00 mg/6 mL,Microcrystalline Cellulose (Avicel PH101 64.000 mg/6 mL,Microcrystalline cellulose 118.960 mg/6 mL,Opadry II White 85F18422 30.000 mg/6 mL,Povidone (Kollidon 30) 15.000 mg/6 mL,Purified Water q.s q.s,Sodium croscarmellose (AC-Di-Sol) 40.000 mg/6 mL,Sodium croscarmellose (AC-Di-Sol) 50.000 mg/6 mL,Sodium starch glycolate (Premajole) 15.000 mg/6 mL,Tenofovir Alafenamide Fumarate 25 mg/6 mL	Film Coated Tablet	Tanzania	TAN 23 HM 0283	Registered/Compliant
ENVUTEG Dolutegravir Sodium 50 mg	TABLETS 50 mg	Botswana	BOT2404313	Registered/Compliant
ENVUTEG Dolutegravir Sodium 50 mg	TABLETS 50 mg	Botswana	BOT2404313A	Registered/Compliant
ENVUTEG Dolutegravir Sodium 50 mg	TABLETS 50 mg	Botswana	BOT2404313B	Registered/Compliant
ENVUTEG DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR ALAFENAMIDE	TABLET, COATED; ORAL 50; 300; 25 MG	Zimbabwe	2022/7.13/6256	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
ENVUTEG LAMIVUDINE USP , TENOFOVIR ALAFENAMIDE AND DOLUTEGRAVIR	300 MG/25 MG/50 MG	Kenya	H2022/CTD9937/21860	Registered
ERESTZ EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE 200mg/35mg/300mg	TABLET 200mg/35mg/300mg	Botswana	BOT2304128	Registered/Compliant
ERESTZ EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE 200/35/300MG	TABLET 200/35/300MG	Botswana	BOT2304128A	Registered/Compliant
Emtricitabine + Tenofovir alafenamide fumarate Emtricitabine 200 mg,Tenofovir Alafenamide Fumarate 25 mg	Tablets	Tanzania	TZ 19 H 0023	Registered/Compliant
Emtricitabine and Tenofovir Alafenamide Tablets 200 mg/25 mg EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	ORAL TABLET 200 mg/25 mg	Rwanda	RWANDA-FDA24/HM/0087/0028	Registered
Envuteg Croscarmellose Sodium(AC-DI-SOL) 40 mg,Croscarmellose Sodium(AC-DI-SOL) 50 mg,Dolutegravir Sodium 52.6 mg,Lactose Monohydrate (Flowlac 100) 60 mg,Lamivudine 300 mg,Magnesium Stearate (Hyqual VG) 1 mg,Magnesium Stearate (Hyqual VG) 14 mg,Mannitol (pearlitol 25C) 131.4 mg,Microcrystalline Cellulose ( Avicel PH 112 ) 64 mg,Microcrystalline Cellulose (Avicel PH 101) 60 mg,Microcrystalline Cellulose (Ceolus UF 702) 118.96 mg,Opadry II White 30 mg,Povidone (K-30) 15 mg,Purified Water qs ml,Sodium starch glycolate (Premajole) 15 mg,Tenofovir Alafenamide Fumarate 28.04 mg	Capsules 1 mg,118.96 mg,131.4 mg,14 mg,15 mg,28.04 mg,30 mg,300 mg,40 mg,50 mg,52.6 mg,60 mg,64 mg,qs ml	Zambia	ZAMRA-HM-23-42	Registered/Compliant
Envuteg Tablets Dolutegravir Sodium 52.6 mg,Lamivudine 300 mg,Tenofovir Alafenamide Fumarate 28.04 mg	Tablet, Filmcoated 28.04 mg,300 mg,52.6 mg	Zambia	ZAMRA-HM-23-42	Registered/Compliant
FAMILIA -	TABLETS	Botswana	BOT2203961	Registered/Compliant

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411 products