Product details
WHO Product ID
WHOAPI-378
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
Porton Pharma Solutions Ltd
1 Fine Chemical Zone, Chongqing, Chemical Industry Park
Changshou,
Chongqing
401221
China
APIMF Version Number
Porton/Darunavir/OP/00/Dec-2018/Amend 06-Dec-2022
Porton/Darunavir/RP/00/Dec-2018/Amend 05-Dec-2021
Porton/Darunavir/RP/00/Dec-2018/Amend 05-Dec-2021
Product Grades
API specification number
3-001963 version 01
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
12
Duration type
Retest period
Packaging
Double PE anti-static bag (pharmaceutical), ribbon strapped tightly. Secondary packaging: layer of composite aluminum bag heat sealed, in Galvanized cover drum
API Manufacturing Site(s)
Porton Pharma Solutions Ltd
1 Fine Chemical Zone, Chongqing, Chemical Industry Park
Changshou,
Chongqing
401221
China