Product details
WHO Product ID
WHOAPI-084
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Artesunate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Huvepharma Italia S.r.l
Via R. Lepetit 142
Garessio,
12075
Italy
APIMF Version Number
CTD-Artesunate 07/07-01-Version 6-Applicant
CTD-Artesunate 07/07-01-Version 6-Restricted
CTD-Artesunate 07/07-01-Version 6-Restricted
Product Grades
API specification number
GAPS 032/3
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
The primary package is a commercial 3-layer aluminium foil polyaluvel bag, packed under nitrogen and stored in fibre drum containers or cardboard boxes.
API Manufacturing Site(s)
Huvepharma Italia S.r.l
Via R. Lepetit 142
Garessio,
12075
Italy