Product details
WHO Product ID
WHOAPI-459
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Dihydroartemisinin
Confirmation of WHO API prequalification document (version date)
Applicant organization
Guilin Pharmaceutical Co., Ltd.
API-I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
APIMF Version Number
Guilin Pharma/Dihydroartemisinin/OP/01/December-2024
Guilin Pharma/Dihydroartemisinin/RP/01/December-2024
Guilin Pharma/Dihydroartemisinin/RP/01/December-2024
Product Grades
API specification number
SMP-QA-030086-04
Storage condition
Store in a refrigerator (2°C to 8°C), protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Colorless LDPE bag placed in black LDPE bag and kept in fiber board drum.
API Manufacturing Site(s)
Guilin Pharmaceutical Co., Ltd.
API-I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China