Product details
WHO Product ID
WHOAPI-118
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Cycloserine
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/Cycloserine/OP/09/2022-04-15
DONG-A/Cycloserine/RP/09/2022-04-15
DONG-A/Cycloserine/OP/09/2022-04-15/Amend01-July-2023
DONG-A/Cycloserine/RP/09/2022-04-15
DONG-A/Cycloserine/OP/09/2022-04-15/Amend01-July-2023
Product Grades
API specification number
Banwol Site: STPB/EA-497-S6(05) ; Sihwa Site: STP/EA-497-S2(11)
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
24
Duration type
Shelf life
Packaging
Polyethylene bag tied with cable tie and packaged in an aluminium bag with silica gel, then placed in a PE drum.
API Manufacturing Site(s)
ST Pharm Co Ltd
Sihwa Site, 231, Hyeomnyeok-ro, Siheung-si
15086
Republic of Korea
ST Pharm Co. Ltd
Banwol Site 2, 171, Haean-ro, Danwon-gu
Ansan-si,
15610
Korea, Rep.