Medicines/finished pharmaceutical products

Reference Number: 
HA551

Date of prequalification: 
12 February 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Emtricitabine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 200mg/300mg
Storage condition: 
Do not store above 30°C, protect from moisture
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 30x1
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, Unit 1 & 2, Ganguwala Village, Paonta Sahib, Sirmour District, Himanchal Pradesh, 173 025, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

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

API WHO Public Inspection Reports: