Medicines/finished pharmaceutical products

Reference Number: 
HA688

Date of prequalification: 
18 December 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 50mg/300mg/300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Bottle, HDPE 30X1, 90X1, 180X1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775, India

API Manufacturing Site: 

(Lamivudine) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India
(Lamivudine) Mylan Laboratories Limited, Unit 2, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy District, Telangana, 502 319, India
(Tenofovir disoproxil fumarate) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India
(Tenofovir disoproxil fumarate) Mylan Laboratories Limited (Unit-10), Plot No. 86, Ramky Pharma City (India) Ltd, JN Pharma City, Parawada Mandal, Visakhapatnam, Andhra Pradesh, 531019, India
(Dolutegravir (sodium)) Mylan Laboratories Ltd, Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Parawada (M), Visakhapatnam District, Andhra Pradesh, 531 021, India