Product details
WHO Product ID
WHOAPI-405b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Micronised
INN
Pyronaridine (phosphate)
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/PTD/RP-2022/00
MDOL/PTD/OP-2022/00
MDOL/PTD/OP-2022/01
MDOL/PTD/OP-2022/00
MDOL/PTD/OP-2022/01
Product Grades
API specification number
DS.SP.IH.PTD-D-M Version No. 1.2 (micronised)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Double polyethylene bags (outer black), in polyethylene drum.
API Manufacturing Site(s)
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India