Product Details
WHO Product ID
HA723
Status
Prequalified
INN, dosage form and strength
Darunavir Tablet, Film-coated 400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
MSN Laboratories Private Limited
“MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Telangana
Hyderabad,
500 018
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moi
API Manufacturing Site(s)
By Organization
By Active Ingredient
MSN Life Sciences Private Limited
Unit II, Sy.No. Parts of 454, 455, 457, 458 & 459 Chandampet (Village), Shankarampet-R (Mandal), Medak District
Telangana
502 255
India
Darunavir
FPP Manufacturing Site(s)
MSN Laboratories Private Limited
Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy (District)
Telangana
509228
India