Product details
WHO Product ID
WHOAPI-035
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Lumefantrine
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/Lumefantrine (A)/OP/0005/March-2022 Desano/Lumefantrine (A)/RP/0005/March-2022
Product Grades
API specification number
SOP-B-QC-121-14
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Two inner PE bags packed into a fibre drum tightly closed and sealed.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China