Product details
WHO Product ID
WHOAPI-450
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Dolutegravir (sodium)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Styrax Pharma Pvt Ltd
Plot No. 27B, Jawaharlal Nehru Pharma City, Parawada, Anakapalli
Andhra Pradesh
531021
India
APIMF Version Number
SP/DRS-IV/OP/01/MAR-2025
SP/DRS-IV/RP/01/MAR-2025
SP/DRS-IV/RP/01/MAR-2025
Product Grades
API specification number
FPSDRS-IV001/06
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
Primary Packaging Material: White low-density polyethylene bags.
Secondary Packaging Material: Black low-density polyethylene bags are used as secondary packaging material.
Secondary Packaging Material: Black low-density polyethylene bags are used as secondary packaging material.
API Manufacturing Site(s)
Styrax Pharma Pvt Ltd
Plot No. 27B, Jawaharlal Nehru Pharma City, Parawada, Anakapalli
Andhra Pradesh
531021
India