Medicines/finished pharmaceutical products

Reference Number: 
HA683

Date of prequalification: 
11 June 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Darunavir (ethanolate)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 800mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle,HDPE 30x1
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 H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136, India

API Manufacturing Site: 

(Darunavir (ethanolate)) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India