Product details
WHO Product ID
WHOAPI-324
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
Pen Tsao Chemical Industry Ltd
27B, CKK Commercial Centre, 289 Hennessy Road, Wanchai
Hong Kong,
China
APIMF Version Number
OP/Version 2/2019.08.20
RP/Version 2/2019.08.20
RP/Version 2/2019.08.20
Product Grades
API specification number
QC-20-A1030EP, Version 05
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
24
Duration type
Retest period
Packaging
Double polyethylene bags inside a fibre drum
API Manufacturing Site(s)
Pen Tsao Chemical & Pharmaceutical Industry Ltd
No 2 Teili Road, Wusong, Baoshan District
Yanghang Town,
Shanghai
200 940
China