Product details
WHO Product ID
WHOAPI-080
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Artemether
Confirmation of WHO API prequalification document (version date)
Applicant organization
Shanghai Desano Chemical Pharmaceutical Co Ltd
1479 Zhangheng Road, Zhangjiang Hi-Tech Park, Pudong
Shanghai,
201 203
China
APIMF Version Number
Desano/Artemether (A)/RP/0005/2020-03
Desano/Artemether (A)/OP/0005/2020-03
Desano/Artemether(A)/OP/0005/Amendment 01/2023-12
Desano/Artemether(A)/RP/0005/Amendment 01/2023-12
Desano/Artemether (A)/OP/0005/2020-03
Desano/Artemether(A)/OP/0005/Amendment 01/2023-12
Desano/Artemether(A)/RP/0005/Amendment 01/2023-12
Product Grades
API specification number
SOP-B-QC-133-08
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Double polythene bags tied separately with a LDPE fastener enclosed in aluminium foil bag (heat-sealed), then in a fibre drum. The top lid is sealed with tape.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China