Product details
WHO Product ID
WHOAPI-496
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Sulfadoxine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Chongqing Kangle Pharmaceutical Co. Ltd.
4 Huazhong Road, Chongqing (Changshou) Chemical Industrial Park
Chongqing,
Chongqing
401 221
China
APIMF Version Number
Chongqing Kangle/Sulfadoxine/OP/00/November-2023 Date: 2023-11-23
Chongqing Kangle/Sulfadoxine/RP/00/November-2023 Date: 2023-11-23
Chongqing Kangle/Sulfadoxine/OP/00/November-2023/ Amend/01/November-2024
Chongqing Kangle/Sulfadoxine/RP/00/November-2023/ Amend/01/November-2024
Chongqing Kangle/Sulfadoxine/OP/00/November-2023/Amend/02/October-2025
Chongqing Kangle/Sulfadoxine/RP/00/November-2023/Amend/02/October-2025
Chongqing Kangle/Sulfadoxine/RP/00/November-2023 Date: 2023-11-23
Chongqing Kangle/Sulfadoxine/OP/00/November-2023/ Amend/01/November-2024
Chongqing Kangle/Sulfadoxine/RP/00/November-2023/ Amend/01/November-2024
Chongqing Kangle/Sulfadoxine/OP/00/November-2023/Amend/02/October-2025
Chongqing Kangle/Sulfadoxine/RP/00/November-2023/Amend/02/October-2025
Product Grades
API specification number
STP-50082-05; effective date 18 Aug 2025
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
The primary packaging materials are double Low-density polyethylene (LDPE) bags and the secondary packaging material is fibre drum.
API Manufacturing Site(s)
Chongqing Kangle Pharmaceutical Co. Ltd.
No.4 Huazhong Road, Chongqing (Changshou) Chemical Industrial Park
Chongqing,
Chongqing
401 221
China