Product details
WHO Product ID
WHOAPI-421
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Influenza
Type
None
Grade
Standard
INN
Oseltamivir (phosphate)
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/Oseltamivir Phosphate/APIMF/OP/0001/2023-04
Desano-B/Oseltamivir Phosphate/APIMF/RP/0001/2023-04
Desano-B/Oseltamivir Phosphate/APIMF/RP/0001/2023-04/Amend 01-Mar-2025
Desano-B/Oseltamivir Phosphate/APIMF/OP/0001/2023-04/Amend 01-Mar-2025
Desano-B/Oseltamivir Phosphate/APIMF/RP/0001/2023-04/Amend 01-Mar-2025/Re-May-2025
Desano-B/Oseltamivir Phosphate/APIMF/RP/0001/2023-04
Desano-B/Oseltamivir Phosphate/APIMF/RP/0001/2023-04/Amend 01-Mar-2025
Desano-B/Oseltamivir Phosphate/APIMF/OP/0001/2023-04/Amend 01-Mar-2025
Desano-B/Oseltamivir Phosphate/APIMF/RP/0001/2023-04/Amend 01-Mar-2025/Re-May-2025
Product Grades
API specification number
SOP-B-QC-1335-01
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Double layer pharmaceutical grade polyethylene (LDPE) bag and aluminum foil bag as inner packaging material, and in a fibre drum with hoop as outer packaging material.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China