Medicines/finished pharmaceutical products

Reference Number: 
HA525

Date of prequalification: 
11 September 2012
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 300mg/300mg
Storage condition: 
Do not store above 30°C, protect from moisture
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 30x1; 90x1
Applicant: 
Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India
FPP Manufacturing Site: 

Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

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

API WHO Public Inspection Reports: