Medicines/finished pharmaceutical products

Reference Number: 
HA678

Date of prequalification: 
31 October 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,PVC/ACLAR 10x1; Bottle,HDPE 30x1,90x1,180x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775, India

API Manufacturing Site: 

(Dolutegravir (sodium)) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India

API WHO Public Inspection Reports: