Dolutegravir (sodium) manufactured by Aurore Life Sciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
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 finished pharmaceutical products (FPPs). FPPs containing dolutegravir (sodium) are used in the therapeutic area of HIV/AIDS.
API prequalification consists of a comprehensive evaluation procedure that has two components: assessment of the API master file (APIMF) 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.