Product details
WHO Product ID
WHOAPI-239b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Micronised
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-015, Version 1 (micronized)
Storage condition
Store in a refrigerator (2 °C to 8 °C)
Storage period (months)
24
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