Product details
WHO Product ID
WHOAPI-520
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard (Form II)
INN
Rifampicin
Confirmation of WHO API prequalification document (version date)
Applicant organization
Hebei Xingang Pharmaceutical Co Ltd
No.2 Fuqiang Street, Zhaoyuan Road, Zhao County
Shijiazhuang City,
Hebei
051 530
China
APIMF Version Number
Open part: 00/R4, May 2025
Restricted part: 00/R4, May 2025
Restricted part: 00/R4, May 2025
Product Grades
API specification number
version 10
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
12
Duration type
Retest period
Packaging
The product is filled into a PE bag, charged with nitrogen, seal the opening. Secondly, the product is put into an aluminium foil bag and heat sealed. Finally it is loaded it into a fiber drum, and closed with a clamp.
API Manufacturing Site(s)
Hebei Xingang Pharmaceutical Co Ltd
No.2 Fuqiang Street, Zhaoyuan Road, Zhao County
Shijiazhuang,
Hebei
051 530
China