Product details
WHO Product ID
WHOAPI-239a
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Dihydroartemisinin
Confirmation of WHO API prequalification document (version date)
Applicant organization
KPC Chongqing Wuling Mountain Pharmaceutical Co., Ltd
2nd Floor, Building 24, No. 3 Minzhuang Road, Yuquan Wisdom Vale, Tsinghua Science Park
Beijing,
100 195
China
APIMF Version Number
HP-APIMF-C002-OP-05
HP-APIMF-C002-RP-04
HP-APIMF-C002-OP-05-Amend01, Issue date 20 September 2022
HP‐APIMF‐C002‐OP‐05-Amend02, Issue date June 02, 2023
HP-APIMF-C002-RP-04
HP-APIMF-C002-OP-05-Amend01, Issue date 20 September 2022
HP‐APIMF‐C002‐OP‐05-Amend02, Issue date June 02, 2023
Product Grades
API specification number
SP-FP-004, Version 2 (non-micronized)
Storage condition
Store in a refrigerator (2 °C to 8 °C)
Storage period (months)
36
Duration type
Retest period
Packaging
Primary pack: PP/PET with aluminium/PE bags; Secondary pack: Plastic drum (with a screw cover)
API Manufacturing Site(s)
KPC Chongqing Wuling Mountain Pharmaceutical Co., Ltd
108 Southern Jinyuan Road, Banxi Light Industry Area, Youyang
Youyang City,
Chongqing
China
KPC Chongqing Wuling Mountain Pharmaceutical Co., Ltd
108 Southern Jinyuan Road, Banxi Light Industry Area, Youyang
Youyang City,
Chongqing
China