Product details
WHO Product ID
WHOAPI-248
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Piperaquine phosphate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Chongqing Kangle Pharmaceutical Co Ltd
4 Huazhong Road, Chongquing (Changshou) Chemical Industrial Park
Chongqing,
Chongqing
401 221
China
APIMF Version Number
Chongqing Kangle/Piperaquine Phosphate/OP/03/November-2021
Chongqing Kangle/Piperaquine Phosphate/RP/03/November-2021
Chongqing Kangle/Piperaquine Phosphate/OP/03/November-2021/Amend 01-May-2022
Chongqing Kangle/Piperaquine Phosphate/RP/03/November-2021/Amend 01-May-2022
Chongqing Kangle/Piperaquine Phosphate/OP/03/November-2021/Amend 01-April-2024
Chongqing Kangle/Piperaquine Phosphate/RP/03/November-2021/Amend 02-April-2024
Chongqing Kangle/Piperaquine Phosphate/RP/03/November-2021
Chongqing Kangle/Piperaquine Phosphate/OP/03/November-2021/Amend 01-May-2022
Chongqing Kangle/Piperaquine Phosphate/RP/03/November-2021/Amend 01-May-2022
Chongqing Kangle/Piperaquine Phosphate/OP/03/November-2021/Amend 01-April-2024
Chongqing Kangle/Piperaquine Phosphate/RP/03/November-2021/Amend 02-April-2024
Product Grades
API specification number
STP-50040-06
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Piperaquine phosphate is packaged into double bags. Inner bag which comes into direct contact with product is low density polyethylene bag. The outside bag is aluminum composite plastic bag. The outside bag is aluminum composite plastic bag. The double bags are then put into a fiber drum, the joint between drum cover and drum body is sealed by packaging tapes with company logo.
API Manufacturing Site(s)
Chongqing Kangle Pharmaceutical Co Ltd
4 Huazhong Road, Chongquing (Changshou) Chemical Industrial Park
Chongqing,
Chongqing
401 221
China