Product details
WHO Product ID
WHOAPI-149b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Micronised
INN
Piperaquine 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/PPS/OP-2021/00 MDOL/PPS/RP-2021/00
MDOL/PPS/OP-2021/01 MDOL/PPS/RP-2021/01
MDOL/PPS/OP-2021/01 MDOL/PPS/RP-2021/01
Product Grades
API specification number
DS.SP.IH.PPS-D-M Version No. 1.0 (micronised)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Primary: LDPE bag tied with a plastic strip in a black LDPE Secondary: HDPE drum sealed with a plastic seal
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