Artemether (WHOAPI-268) manufactured by Chongqing Holley Wuling Mountain Pharmaceutical Co Ltd and Darunavir (ethanolate) (WHOAPI-214) manufactured by Mylan Laboratories Ltd have been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.
- WHOAPI-214 - Darunavir (ethanolate) - Mylan Laboratories Ltd - INDIA - This is the first darunavir API to be prequalified.
- FPPs containing Darunavir (ethanolate) are used in the therapeutic area of HIV/AIDS
- WHOAPI-268 - Artemether - Chongqing Holley Wuling Mountain Pharmaceutical Co Ltd - CHINA
- FPPs containing Artemether are used in the therapeutic area of Malaria
Good-quality APIs are vital to the production of good-quality medicines. WHO prequalification of APIs facilitates production of quality medicines by identifying such APIs for use by manufacturers of FPPs.
API prequalification consists of a comprehensive evaluation procedure that has two components: assessment of the API master file to verify compliance with WHO norms and standards, and evaluation of the sites of API manufacture to verify compliance with WHO Good Manufacturing Practice requirements.