Product details
WHO Product ID
WHOAPI-469
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Covid-19
Type
None
Grade
Standard
INN
Nirmatrelvir
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/Nirmatrelvir/APIMF/OP/0001/Aug-2023
Desano-B/Nirmatrelvir/APIMF/RP/0001/Aug-2023
Desano-B/Nirmatrelvir/APIMF/OP/0001/Aug-2023/Amend 01-Oct-2024
Desano-B/Nirmatrelvir/APIMF/RP/0001/Aug-2023/Amend 01-Oct-2024
Desano-B/Nirmatrelvir/APIMF/RP/0001/Aug-2023
Desano-B/Nirmatrelvir/APIMF/OP/0001/Aug-2023/Amend 01-Oct-2024
Desano-B/Nirmatrelvir/APIMF/RP/0001/Aug-2023/Amend 01-Oct-2024
Product Grades
API specification number
SOP -B-QC-1443-03
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
The material is packed in double layer polyethylene bag and tied with plastic slide fastener. The polyethylene bag containing material is then placed in an aluminum foil bag, heat sealed and packed in a fibre drum with hoop.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China