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): 
36
Packaging: 
Bottle,HDPE 60x1
Applicant: 
Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

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

API Manufacturing Site: 

(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

API WHO Public Inspection Reports: