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WHOAPI-512: Tenofovir alafenamide

Product details
WHO Product ID
WHOAPI-512
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Tenofovir alafenamide
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/TAF-Fumarate/APIMF/OP/0000/May-2024
Desano-B/TAF-Fumarate/APIMF/RP/0000/May-2024
Desano-B/TAF-Fumarate/APIMF/OP/0000/May-2024/RE-Aug-2025
Desano-B/TAF-Fumarate/APIMF/RP/0000/May-2024/RE-Aug-2025
Desano-B/TAF-Fumarate/APIMF/OP/0000/May-2024/RE-Aug-2025/RE-May-2026
Desano-B/TAF-Fumarate/APIMF/RP/0000/May-2024/RE-Aug-2025/RE-May-2026
Desano-B/TAF-Fumarate/APIMF/OP/0000/May-2024/RE-Aug-2025/RE-May-2026/RE-Jul-2026
Desano-B/TAF-Fumarate/APIMF/RP/0000/May-2024/RE-Aug-2025/RE-May-2026/RE-Jul-2026
Product Grades
API specification number
SOP-B-QC-1798-00
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Primary packaging: double low-density polyethylene (LDPE) bag both tied separately with a LDPE fastener.
Secondary packaging: aluminium foil bag, and heat seal.
Outer container: fibre drum sealed with a hoop.
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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