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 and 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