Product details
WHO Product ID
WHOAPI-042
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
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
APIMF Version Number
LU/DMF/AP/04/2021-06-15
LU/DMF/RP/03/2021-06-15
LU/DMF/AP/04/2021-06-15/Amend-01 June 2022
LU/DMF/RP/04/2021-06-15/Amend-01 June 2022
LU/DMF/AP/04/2021-06-15/Amend-02 January 2023
LU/DMF/RP/04/2021-06-15/Amend-02 January 2023
LU/DMF/AP/04/2021-06-15/Amend-03 June 2023
LU/DMF/RP/03/2021-06-15
LU/DMF/AP/04/2021-06-15/Amend-01 June 2022
LU/DMF/RP/04/2021-06-15/Amend-01 June 2022
LU/DMF/AP/04/2021-06-15/Amend-02 January 2023
LU/DMF/RP/04/2021-06-15/Amend-02 January 2023
LU/DMF/AP/04/2021-06-15/Amend-03 June 2023
Product Grades
API specification number
TS/API/LU3/DMF version 5.0
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Twin LDPE bags placed in fibre drums or in HMHPDE drum
API Manufacturing Site(s)
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India