Product details
WHO Product ID
WHOAPI-445
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
Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd.
No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China
APIMF Version Number
LONZEAL/DOLUTEGRAVIR SODIUM/OP/01/JUNE-2025
LONZEAL/DOLUTEGRAVIR SODIUM/RP/01/JUNE-2025
LONZEAL/DOLUTEGRAVIR SODIUM/RP/01/JUNE-2025
Product Grades
API specification number
TS05-156-03
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Primary Packaging : Low-density polyethylene (LDPE) bags
Secondary packaging : Aluminum plastic bags
Secondary packaging : Aluminum plastic bags
API Manufacturing Site(s)
Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd.
No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China