Product details
WHO Product ID
WHOAPI-278
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Pyrimethamine
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/Pyrimethamine/OP/03/November-2021
Guilin Pharma/Pyrimethamine/RP/03/November-2021
Guilin Pharma/Pyrimethamine/RP/03/November-2021/Amend 01-October-2022
Guilin Pharma/Pyrimethamine/RP/03/November-2021/Amend 02-October-2022
Guilin Pharma/Pyrimethamine/RP/03/November-2021/Amend 03-April-2023
Guilin Pharma/Pyrimethamine/OP/03/November-2021/Amend 01-August-2023
Guilin Pharma/Pyrimethamine/RP/03/November-2021/Amend 04-August-2023
Guilin Pharma/Pyrimethamine/RP/03/November-2021
Guilin Pharma/Pyrimethamine/RP/03/November-2021/Amend 01-October-2022
Guilin Pharma/Pyrimethamine/RP/03/November-2021/Amend 02-October-2022
Guilin Pharma/Pyrimethamine/RP/03/November-2021/Amend 03-April-2023
Guilin Pharma/Pyrimethamine/OP/03/November-2021/Amend 01-August-2023
Guilin Pharma/Pyrimethamine/RP/03/November-2021/Amend 04-August-2023
Product Grades
API specification number
SMP-QA-020061-23
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Double transparent LDPE bags in a fibreboard drum
API Manufacturing Site(s)
Guilin Pharmaceutical Co Ltd
Workshop I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China