Medicines/finished pharmaceutical products

Reference Number: 
HA657

Date of prequalification: 
28 November 2017
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
Shelf life (months): 
24
Packaging: 
Blister, Alu/Alu 10x10; Container, HDPE 30x1
Applicant: 
Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, 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

API Manufacturing Site: 

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

API WHO Public Inspection Reports: