Medicines/finished pharmaceutical products

Reference Number: 
HA698

Date of prequalification: 
11 June 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Abacavir (sulfate)/Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 600mg/300mg
Storage condition: 
Do not store above 30°C, avoid excursions above 30°C
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: 

(Abacavir (sulfate)) 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: