Product details
WHO Product ID
WHOAPI-331
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Clofazimine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Dong-A ST Co., Ltd.
64, Cheonho-daero, Dongdaemun-gu,
Seoul,
02587
Republic of Korea
APIMF Version Number
Dong-A/Clofazimine/OP/02/2021-11-12
Dong-A/Clofazimine/RP/02/2021-11-12
Dong-A/Clofazimine/OP/02/Amend-01-Sep-2022
Dong-A/Clofazimine/RP/02/Amend-01-Sep-2022
Dong-A/Clofazimine/RP/02/Amend-02-Feb-2023
Dong-A/Clofazimine/RP/02/Amend-03-March-2023
Dong-A/Clofazimine/OP/02/Amend-02-Dec-2023
Dong-A/Clofazimine/OP/02/Amend-03-Feb-2024
DONG-A/Clofazimine/OP/02/Amend-04-Mar-2024
DONG-A/Clofazimine/RP/02/Amend-04-Mar-2024
DONG-A/Clofazimine/RP/02/Amend-22-Apr-2025
Dong-A/Clofazimine/RP/02/2021-11-12
Dong-A/Clofazimine/OP/02/Amend-01-Sep-2022
Dong-A/Clofazimine/RP/02/Amend-01-Sep-2022
Dong-A/Clofazimine/RP/02/Amend-02-Feb-2023
Dong-A/Clofazimine/RP/02/Amend-03-March-2023
Dong-A/Clofazimine/OP/02/Amend-02-Dec-2023
Dong-A/Clofazimine/OP/02/Amend-03-Feb-2024
DONG-A/Clofazimine/OP/02/Amend-04-Mar-2024
DONG-A/Clofazimine/RP/02/Amend-04-Mar-2024
DONG-A/Clofazimine/RP/02/Amend-22-Apr-2025
Product Grades
API specification number
STP/EA-582-S1(13); STP/EA-582-S2(01)
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Double low-density polyethylene bags inside a polyethylene drum.
API Manufacturing Site(s)
ST Pharm Co Ltd
Sihwa Site, 231, Hyeomnyeok-ro, Siheung-si
15086
Republic of Korea