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WHOAPI-035: Lumefantrine

Product details
WHO Product ID
WHOAPI-035
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
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
Desano/Lumefantrine (A)/OP/0005/Amend03-July-2023
Desano/Lumefantrine (A)/RP/0005/Amend03-July-2023
Desano /Lumefantrine(A)/OP/0005/Amend03-response-Dec. 2023
Desano /Lumefantrine(A)/RP/0005/Amend03-response-Dec. 2023
Desano /Lumefantrine(A)/OP/0005/Amend03-response-June 2024
Desano /Lumefantrine(A)/RP/0005/Amend03-response-June 2024
Desano /Lumefantrine(A)/OP/0005/Amend03-response-August 2024
Desano /Lumefantrine(A)/RP/0005/Amend03-response-August 2024
Desano /Lumefantrine(A)/OP/0005/Amend03-response-October 2024
Desano /Lumefantrine(A)/RP/0005/Amend03-response-October 2024
Product Grades
API specification number
SOP-B-QC-121-17
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

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