Product details
WHO Product ID
WHOAPI-135
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Artesunate
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/ARS/OP-2021/00
MDOL/ARS/RP-2021/00
MDOL/ARS/OP-2021/01
MDOL/ARS/RP-2021/01
MDOL/ARS/RP-2021/02
MDOL/ARS/RP-2021/03
MDOL/ARS/RP-2021/00
MDOL/ARS/OP-2021/01
MDOL/ARS/RP-2021/01
MDOL/ARS/RP-2021/02
MDOL/ARS/RP-2021/03
Product Grades
API specification number
DS.SP.Ph.Int.ASD-D Version 1.0
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Shelf life
Packaging
Double food grade polyethylene bags (LDPE), the outer bag being black. The bags are tied with plastic strips and placed in either HDPE or fiber drums.
API Manufacturing Site(s)
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India