WHO Product ID
HA793
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium) Tablet, Dispersible 10mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 60x1, 90x1
Shelf life (months)
21
API Manufacturing Site(s)
By Organization
By Active Ingredient
Micro Labs Limited
API - Division (ML-15), Plot No.43-45, KIADB, Jigani-Bommasandra Link Road, Anekal Taluk
Bengaluru,
Karnataka
560 105
India
Dolutegravir (sodium)
FPP Manufacturing Site(s)
Micro Labs Limited
Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate
Verna,
Goa
403 722
India