Product details
WHO Product ID
WHOAPI-208a
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Tenofovir disoproxil fumarate
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/Tenofovir DF/OP/0005/2020-09-28
Desano-B/Tenofovir DF/RP/0005/2020-09-28
Desano-B/Tenofovir DF/OP/0005/2020-09-28/Amend 01-April-2021
Desano-B/Tenofovir DF/OP/ 0005/2020-09-28/Amend 01-April-2021
Desano-B/Tenofovir DF/OP/0005/2020-09-28/Amend 01-Oct-2021
Desano-B/Tenofovir DF/RP/0005/2020-09-28/Amend 01-Oct-2021
Desano-B/Tenofovir DF/RP/0005/2020-09-28/Amend 01-Dec-2021
Desano-B/Tenofovir DF/OP/0005/2020-09-28/Amend 02-Sep-2022
Desano-B/Tenofovir DF/RP/0005/2020-09-28/Amend 02-Sep-2022
Desano-B/Tenofovir DF/RP/0005/2020-09-28
Desano-B/Tenofovir DF/OP/0005/2020-09-28/Amend 01-April-2021
Desano-B/Tenofovir DF/OP/ 0005/2020-09-28/Amend 01-April-2021
Desano-B/Tenofovir DF/OP/0005/2020-09-28/Amend 01-Oct-2021
Desano-B/Tenofovir DF/RP/0005/2020-09-28/Amend 01-Oct-2021
Desano-B/Tenofovir DF/RP/0005/2020-09-28/Amend 01-Dec-2021
Desano-B/Tenofovir DF/OP/0005/2020-09-28/Amend 02-Sep-2022
Desano-B/Tenofovir DF/RP/0005/2020-09-28/Amend 02-Sep-2022
Product Grades
API specification number
SOP-B-QC-139-24
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from moisture, protect from ligh
Storage period (months)
48
Duration type
Retest period
Packaging
Packed with two low density polythene bags, which are filled with nitrogen gas and tied separately with LDPE fastener, then placed in aluminium foil bag and closed with heat-seal.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Leping Safely Pharmaceutical
Tsahan Industrial Zone
Leping City,
Jiangxi
333300
China