Medicines/finished pharmaceutical products

Reference Number: 
HA674

Date of prequalification: 
30 June 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Abacavir (sulfate)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Dispersible 60mg
Storage condition: 
Do not store above 30°C, protect from moisture, protect from light
Shelf life (months): 
48
Packaging: 
Bottle,HDPE 60x1
Applicant: 
Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa, 403 722, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

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