Product details
WHO Product ID
WHOAPI-235
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Artemether
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-Artemether 10/13-Version 3- Applicant
CTD-Artemether 10/13-Version 3- Restricted
CTD-Artemether 10/13-Version 3- Restricted
Product Grades
API specification number
GAPS 040/4
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from light
Storage period (months)
6
Duration type
Retest period
Packaging
Artemether is packaged in polyaluvel type bag. The bags are placed into fibre or plastic drum or cardboard boxes
API Manufacturing Site(s)
Huvepharma Italia S.r.l
Via R. Lepetit 142
Garessio,
12075
Italy