Product details
WHO Product ID
WHOAPI-355
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
Guilin Pharmaceutical Co Ltd
Workshop I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
APIMF Version Number
Guilin Pharma/Artesunate/OP/02/July-2021
Guilin Pharma/Artesunate/RP/02/July-2021
Guilin Pharma/Artesunate/RP/02/July-2021
Product Grades
API specification number
SMP-QA-030085-05
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Two layer of colourless, transparent polyethylene bags and one layer of black polyethylene bag.
API Manufacturing Site(s)
Guilin Pharmaceutical Co Ltd
Workshop I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China