Medicines/finished pharmaceutical products

Reference Number: 
HA521

Date of prequalification: 
14 June 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine/Zidovudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 150mg/300mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 60x1
Applicant: 
Hetero Labs Ltd, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Ranga Reddy District, Telangana, 500 018, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India
Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India

API Manufacturing Site: 

(Zidovudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Zidovudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Lamivudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Lamivudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Lamivudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Zidovudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District, Telangana, 502319, India