Product details
WHO Product ID
WHOAPI-289
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Atazanavir (sulfate)
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/Atazanavir sulfate/APIMF/OP/0004/2021-03-04
Desano-B/Atazanavir sulfate /APIMF/RP/0004/2021-03-04
Desano-B/Atazanavir sulfate/APIMF/RP/0004/2021-03-04/ Amend 01/June 2023
Desano-B/Atazanavir sulfate/APIMF/OP/0004/2021-03-04/Amend 01/June 2023
Desano-B/Atazanavir sulfate /APIMF/RP/0004/2021-03-04
Desano-B/Atazanavir sulfate/APIMF/RP/0004/2021-03-04/ Amend 01/June 2023
Desano-B/Atazanavir sulfate/APIMF/OP/0004/2021-03-04/Amend 01/June 2023
Product Grades
API specification number
SOP-B-QC-1042-14
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Primary – Double LDPE bags, which are sealed with LDPE fastener. Secondary - Aluminum foil bag closed with heat-seal, Tertiary- Fibre drum
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China