Product details
WHO Product ID
WHOAPI-331
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
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,
130 708
Korea, Rep.
APIMF Version Number
Dong-A/Clofazimine/OP/02/2021-11-12
Dong-A/Clofazimine/RP/02/2021-11-12
Dong-A/Clofazimine/RP/02/2021-11-12
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)
36
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