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, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Ranga Reddy District, 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
Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India

API Manufacturing Site: 

(Dolutegravir (sodium)) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Dolutegravir (sodium)) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District, Telangana, 502319, India