Product details
WHO Product ID
WHOAPI-279
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Sulfadoxine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Guilin Pharmaceutical Co Ltd
Workshop I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
APIMF Version Number
Guilin Pharma/Sulfadoxine/OP/03/November-2021
Guilin Pharma/Sulfadoxine/RP/03/November-2021
Guilin Pharma/Sulfadoxine/RP/03/November-2021/Amend 01-February-2022
Guilin Pharma/Sulfadoxine/RP/03/November-2021/Amend 02-February-2022
Guilin Pharma/Sulfadoxine/OP/03/November-2021/Amend 01-July-2023
Guilin Pharma/Sulfadoxine/RP/03/November 2021/Amend 03-September-2023
Guilin Pharma/Sulfadoxine/OP/03/November-2021/Amend 02-October-2023
Guilin Pharma/Sulfadoxine/RP/03/November-2021/Amend 03-October-2023
Guilin Pharma/Sulfadoxine/RP/03/November-2021/Amend 04-December-2023
Guilin Pharma/Sulfadoxine/RP/03/November-2021
Guilin Pharma/Sulfadoxine/RP/03/November-2021/Amend 01-February-2022
Guilin Pharma/Sulfadoxine/RP/03/November-2021/Amend 02-February-2022
Guilin Pharma/Sulfadoxine/OP/03/November-2021/Amend 01-July-2023
Guilin Pharma/Sulfadoxine/RP/03/November 2021/Amend 03-September-2023
Guilin Pharma/Sulfadoxine/OP/03/November-2021/Amend 02-October-2023
Guilin Pharma/Sulfadoxine/RP/03/November-2021/Amend 03-October-2023
Guilin Pharma/Sulfadoxine/RP/03/November-2021/Amend 04-December-2023
Product Grades
API specification number
SMP-QA-020022-26
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Double colourless, transparent, low density polyethylene bags in fibre drum
API Manufacturing Site(s)
Guilin Pharmaceutical Co Ltd
Workshop II No 43 Qilidian Road
Guilin,
Guangxi
541 004
China