Product details
WHO Product ID
WHOAPI-307
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Para-aminosalicylate (sodium)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Liaoyuan Silver Eagle Pharmaceutical Co Ltd
No.2, Wealth Northern Road, Youyi Industrial Park, Liaoyuan Economic Development Zone
Liaoyuan City,
Jilin
136200
China
APIMF Version Number
Restricted Part: Version No.: 1.0 CTD-format October 2020
Open Part: Version No.: 1.0 CTD-format October 2020
Open Part: Version No.: 1.0 CTD-format October 2020
Product Grades
API specification number
STP.QA-CB-020(09)
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
12
Duration type
Retest period
Packaging
Polyester, poly aluminium, Polyethylene bag
API Manufacturing Site(s)
Liaoyuan Silver Eagle Pharmaceutical Co Ltd
No.2, Wealth Northern Road, Youyi Industrial Park, Liaoyuan Economic Development Zone
Liaoyuan City,
Jilin
136200
China