Product details
WHO Product ID
WHOAPI-137
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
Solara Active Pharma Sciences Ltd
120 A & B, 36, 120P & 121 Industrial Area, Baikampady
New Mangalore,
Karnataka
575 011
India
APIMF Version Number
Solara/DMF/Lumefantrine/OP/001/October, 2020
Solara/DMF/Lumefantrine/RP/001/October, 2020
Solara/DMF/Lumefantrine/RP/001/October, 2020
Product Grades
API specification number
BBZ/FP/R5
Storage condition
Do not store above 30°C
Storage period (months)
36
Duration type
Retest period
Packaging
Food grade white HMHDPE bags enclosed in black HMHDPE bags and stored in HDPE drums.
API Manufacturing Site(s)
Solara Active Pharma Sciences Ltd
120 A & B, 36, 120P & 121 Industrial Area, Baikampady
New Mangalore,
Karnataka
575 011
India