Product details
WHO Product ID
WHOAPI-181
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Artemether
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/Artemether/005/January-2022
Guilin Pharma/Artemether/005/January-2022/Amend 01-May-2023
Guilin Pharma/Artemether/005/January-2022/Amend 01-May-2023
Product Grades
API specification number
SMP-QA-030095-01
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from light
Storage period (months)
30
Duration type
Retest period
Packaging
Primary packaging consists of two layers of transparent LDPE bags. Secondary packaging is black LDPE bag and then packed in a fibreboard/cardboard drum.
API Manufacturing Site(s)
Guilin Pharmaceutical Co Ltd
Workshop I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China