Product details
WHO Product ID
WHOAPI-430
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
Emcure Pharmaceuticals Limited
Plot No. P1 & P2, I.T.B.T. Park Phase II., M.I.D.C., Hinjawadi
Pune,
Maharashtra
411057
India
APIMF Version Number
EMCURE/DOLUTEGRAVIR SODIUM/OP/00/Jun-2021
EMCURE/DOLUTEGRAVIR SODIUM/RP/00/Jun-2021
EMCURE/DOLUTEGRAVIR SODIUM/OP/00/JUN-2021/Amend-01-MAY-2022
EMCURE/DOLUTEGRAVIR SODIUM/RP/00/JUN-2021/Amend-01-MAY-2022
EMCURE/DOLUTEGRAVIR SODIUM/OP/00/JUN-2021/Amend-02-AUG-2023
EMCURE/DOLUTEGRAVIR SODIUM/RP/00/JUN-2021/Amend-02-AUG-2023
EMCURE/DOLUTEGRAVIR SODIUM/RP/00/Jun-2021
EMCURE/DOLUTEGRAVIR SODIUM/OP/00/JUN-2021/Amend-01-MAY-2022
EMCURE/DOLUTEGRAVIR SODIUM/RP/00/JUN-2021/Amend-01-MAY-2022
EMCURE/DOLUTEGRAVIR SODIUM/OP/00/JUN-2021/Amend-02-AUG-2023
EMCURE/DOLUTEGRAVIR SODIUM/RP/00/JUN-2021/Amend-02-AUG-2023
Product Grades
API specification number
SC-DS-635/01
Storage condition
Do not store above 30°C
Storage period (months)
36
Duration type
Retest period
Packaging
The material is packed under nitrogen in transparent, double low-density polythene bags and enclosed in fiber drum. Desiccant silica bags placed between two polythene bags.
API Manufacturing Site(s)
Emcure Pharmaceuticals Ltd
Plot no. D-24 &D24/1, MIDC Kurkumbh Industrial Area, Daund, Pune District
Maharashtra
413802
India