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WHOAPI-302: Dolutegravir (sodium)

Product details
WHO Product ID
WHOAPI-302
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Dolutegravir (sodium)
Reference authority
European Directorate for the Quality of Medicines & Healthcare (EDQM)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Shanghai Desano Chemical Pharmaceutical Co Ltd
1479 Zhangheng Road, Zhangjiang Hi-Tech Park, Pudong
Shanghai,
201 203
China
APIMF Version Number
Desano-B/Dolutegravir Sodium/APIMF/OP/0002/2020-11-09
Desano-B/Dolutegravir Sodium/APIMF/RP/0002/2020-11-09
Desano-B/Dolutegravir Sodium/APIMF/OP/0002/2020-11-09/Amend01-April-2021
Desano-B/Dolutegravir Sodium/APIMF/RP/0002/2020-11-09/Amend01-April-2021
Desano-B/Dolutegravir Sodium/APIMF/OP/0002/2020-11-09/Amend02-Nov-2022
Desano-B/Dolutegravir Sodium/APIMF/RP/0002/2020-11-09/Amend02-Nov-2022
Desano-B/Dolutegravir Sodium/APIMF/RP/0002/2020-11-09/Amend02-Nov-2022/response01
Desano-B/Dolutegravir Sodium/APIMF/RP/0002/2020-11-09/Amend03-Aug.-2023
Product Grades
API specification number
SOP-B-QC-1095-12
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
Primary - double low density polyethylene bags, which are sealed with plastic slide fastener. Secondary - Fibre drum, the lid is sealed with tape
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China

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