Product details
WHO Product ID
WHOAPI-049a
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Zidovudine
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/Zidovudine/OP/0005/2021-11-19
Desano/Zidovudine/RP/0005/2021-11-19
Amendment 01, April 2022
Desano/Zidovudine/OP/0005/2021-11-19/Amend01-Oct.-2022
Desano/Zidovudine/RP/0005/2021-11-19/Amend01-Oct-2022
Desano/Zidovudine/RP/0005/2021-11-19/Amend01-Mar-2023
Desano/Zidovudine/OP/0005/2021-11-19/Amend01-Mar-2023
Desano/Zidovudine/OP/0005/2021-11-19/Amend02-Jun.-2023
Desano/Zidovudine/OP/0005/2021-11-19/Amend02-Sep.-2023
Desano/Zidovudine/RP/0005/2021-11-19/Amend02-Sep.-2023
Desano/Zidovudine/RP/0005/2021-11-19
Amendment 01, April 2022
Desano/Zidovudine/OP/0005/2021-11-19/Amend01-Oct.-2022
Desano/Zidovudine/RP/0005/2021-11-19/Amend01-Oct-2022
Desano/Zidovudine/RP/0005/2021-11-19/Amend01-Mar-2023
Desano/Zidovudine/OP/0005/2021-11-19/Amend01-Mar-2023
Desano/Zidovudine/OP/0005/2021-11-19/Amend02-Jun.-2023
Desano/Zidovudine/OP/0005/2021-11-19/Amend02-Sep.-2023
Desano/Zidovudine/RP/0005/2021-11-19/Amend02-Sep.-2023
Product Grades
API specification number
SOP-B-QC-100-20 (Pure); SOP-B-QC-218-18 (Recovered)
Storage condition
Do not store above 30°C
Storage period (months)
48
Duration type
Retest period
Packaging
Double low density polythene bags, tied separately and housed within brown fibre drums with tape-sealed lids.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China