Product details
WHO Product ID
WHOAPI-435
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
Aurore Life Sciences Private Limited
Plot No. 68, 69, 2nd Floor Jubilee Heights Hitech City Near Shilparamam
Madhapur, Hyderabad,
Telangana
500 081
India
APIMF Version Number
Dolutegravir sodium/OP/May-2023
Dolutegravir sodium/RP/May-2023
Dolutegravir sodium/RP/May-2023
Product Grades
API specification number
STP/FPR/DGS/001/06
Storage condition
Do not store above 25°C, protect from moisture
Storage period (months)
24
Duration type
Retest period
Packaging
Primary packaging: double polyethylene bags inner transparent and outer black
Secondary packaging: HDPE drum
Secondary packaging: HDPE drum
API Manufacturing Site(s)
Aurore Pharmaceuticals Private Limited
Unit 1, Plot Nos. 35, 36, 38 to 40, 49 to 51, Phase IV, IDA, Jeedimetla
Hyderabad,
Telangana
500055
India