Medicines/finished pharmaceutical products

Reference Number: 
HA668

Date of prequalification: 
21 January 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle,HDPE 30x1
Applicant: 
Beximco Pharmaceuticals Ltd, 19, Dhanmondi R/A, Road No. 7, Dhaka, 1205, Bangladesh
FPP Manufacturing Site: 

Beximco Pharmaceuticals Ltd, 126 Kathaldia, Auchpara, Tongi, Gazipur, Dhaka, 1711, Bangladesh

API Manufacturing Site: 

(Lamivudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Lamivudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India

API WHO Public Inspection Reports: