Product details
WHO Product ID
WHOAPI-329
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Micronised
INN
Dolutegravir (sodium)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
APIMF Version Number
MLL/DOL/APIMF/AP/02, July-2021
MLL/DOL/APIMF/RP/02, July-2021
MLL/DOL/APIMF/RP/02, July-2021
Product Grades
API specification number
FPSPPI165 Revision Number: 07 (micronised)
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
60
Duration type
Retest period
Packaging
Transparent LDPE-bag filled with nitrogen and black LDPE bag/triple laminated aluminium bag/HDPE drum
API Manufacturing Site(s)
Micro Labs Ltd
API - Division (ML-15), Plot No.43-45, KIADB, Jigani-Bommasandra Link Road, Anekal Taluk
Bengaluru,
Karnataka
560 105
India