Product details
WHO Product ID
WHOAPI-227
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Piperaquine phosphate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
APIMF Version Number
Ipca/Piperaquine Phosphate/ PU4/AP/03/2022-01-06-January 2022
Ipca/Piperaquine Phosphate/PU4/RP/03/2022-01-06- January 2022
Ipca/Piperaquine Phosphate/PU4/RP/03/2022-01-06- January 2022
Product Grades
API specification number
TS/BPC/PU4/CS/DMF rev. No. 06
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
48
Duration type
Retest period
Packaging
Piperaquine Phosphate is packed in clear LDPE bag followed by black LDPE bag and further bags are tied with plastic strip seal and then packed in HMHDPE drum and sealed with locking seal.
API Manufacturing Site(s)
Ipca Laboratories Ltd
89A-B, 90/91 Industrial Estate, Pologround
Indore,
Madhya Pradesh
452 003
India