Product details
WHO Product ID
WHOAPI-121
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
Calyx Chemicals & Pharmaceuticals Ltd
A-37, 38 Kalyan Shill Road, MIDC Phase-I, Golvali, Thane District
Dombivli,
Maharashtra
421 203
India
APIMF Version Number
Calyx/Lumefantrine/OP/04/May-2020
Calyx/Lumefantrine/RP/04/May-2020
Amendment 13 – Oct 2020
Calyx/Lumefantrine/RP/04/May-2020
Amendment 13 – Oct 2020
Product Grades
API specification number
SP/FP/59 Revision 15
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Twin HMHDPE translucent and black bags or LDPE transparent and black bags placed in HDPE drums
API Manufacturing Site(s)
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India