Medicines/finished pharmaceutical products

Reference Number: 
HA682

Date of prequalification: 
17 July 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Dolutegravir (Sodium)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 50mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister,Alu/Alu 10x8; Bottle,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 III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India

API Manufacturing Site: 

(Dolutegravir (sodium)) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India

API WHO Public Inspection Reports: