Product details
WHO Product ID
WHOAPI-350
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Darunavir (ethanolate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Zhejiang Jiangbei Pharmaceutical Co Ltd
Zhang’an Street, Dongdai Village, Jiaojiang
Taizhou,
Zhejiang
318 017
China
APIMF Version Number
Darunavir Ethanolate/OP/02/May-2021
Darunavir Ethanolate/RP/02/May-2021
Darunavir Ethanolate/RP/02/May-2021
Product Grades
API specification number
TS01-ZLC149-001, version 09
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Two-layer polyethylene bag in one-layer foil bag.
API Manufacturing Site(s)
Zhejiang Jiangbei Pharmaceutical Co Ltd
Zhang’an Street, Dongdai Village, Jiaojiang
Taizhou,
Zhejiang
318 017
China