Product details
WHO Product ID
WHOAPI-176
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
Zhuhai Rundu Pharmaceutical Co Ltd
No 6 North Airport Road, Sanzao Town, Jinwan District
Zhuhai,
Guangdong
519 041
China
APIMF Version Number
ZHRD/PQP/OP/2.3/2021-02
ZHRD/PQP/RP/2.3/2021-02
ZHRD/PQP/RP/2.3/2021-02
Product Grades
API specification number
A1-QC3401-13
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
The product is primarily packed in a clear LDPE bag, and into a black LDPE bag for light protected, sealed with nylon buckle. The sealed PE bag is kept in a fiber drum. The drum is sealed with ion ring and labelled.
API Manufacturing Site(s)
Zhuhai Rundu Pharmaceutical Co Ltd
No 6 North Airport Road, Sanzao Town, Jinwan District
Zhuhai,
Guangdong
519 041
China