Product details
WHO Product ID
WHOAPI-191
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Ritonavir
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/Ritonavir/OP/0005/2020-02-24
Desano-B/Ritonavir/RP/0005/2020-02-24
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 01-Oct-2020
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 01-Oct-2020
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 01-Nov-2020
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 02-Feb-2022
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 02-Feb-2022
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 02-Apr-2022
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 03-Jan-2023
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 03-Jan-2023
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 03/Mar-2023
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 04-Jun-2023
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 04-Jun-2023
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 04-Aug-2023
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 04-Aug-2023
Desano-B/Ritonavir/RP/0005/2020-02-24
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 01-Oct-2020
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 01-Oct-2020
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 01-Nov-2020
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 02-Feb-2022
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 02-Feb-2022
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 02-Apr-2022
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 03-Jan-2023
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 03-Jan-2023
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 03/Mar-2023
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 04-Jun-2023
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 04-Jun-2023
Desano-B/Ritonavir/OP/0005/2020-02-24/Amend 04-Aug-2023
Desano-B/Ritonavir/RP/0005/2020-02-24/Amend 04-Aug-2023
Product Grades
API specification number
SOP-B-QC-135-19
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
The primary packaging comprises two low density polyethylene (LDPE) bags sealed with a LDPE closure. The secondary packaging is a brown fibre drum closed with a lid and sealed with a hoop closure.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China