Product details
WHO Product ID
WHOAPI-084
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Artesunate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Olon S.p.A.
Strada Rivoltana, km 6/7
Rodano,
Milan
20090
Italy
APIMF Version Number
Restricted Part :
Olon/Artemether/WHO/RP/Version 7/Apr 2025
Applicant Part :
Olon/Artemether/WHO/AP/Version 7/Apr 2025
Olon/Artemether/WHO/RP/Version 7/Apr 2025
Applicant Part :
Olon/Artemether/WHO/AP/Version 7/Apr 2025
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)
Olon S.p.A
Via R. Lepetit 142
Garessio,
12075
Italy