Medicines/finished pharmaceutical products

Reference Number: 
HA575 *

Date of prequalification: 
13 August 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Abacavir (sulfate)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
HDPE Container 60x1; HDPE Container 500x1
Applicant: 
Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India

API Manufacturing Site: 

(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: