Product details
WHO Product ID
WHOAPI-100
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
Mangalam Drugs & Organics Ltd
Rupam Building, 3rd Floor, 239 P.D'mello Rd, near GPO
Mumbai,
Maharashtra
400 001
India
APIMF Version Number
MDOL/LUF/OP-2021/00
MDOL/LUF/RP-2021/00
MDOL/LUF/OP-2021/01
MDOL/LUF/RP-2021/01
MDOL/LUF/OP-2021/02
MDOL/LUF/RP-2021/02
MDOL/LUF/RP-2021/00
MDOL/LUF/OP-2021/01
MDOL/LUF/RP-2021/01
MDOL/LUF/OP-2021/02
MDOL/LUF/RP-2021/02
Product Grades
API specification number
DS.SP.Ph.Int.LUF-D Version 1.1
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Tied double LDPE bags; primary is white & secondary is black, housed within HDPE drums
API Manufacturing Site(s)
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India