Newly prequalified Active Pharmaceutical Ingredients (APIs)

News

20 September, 2018 - 04:00 (CEST)

Efavirenz (WHOAPI-318) manufactured by Mangalam Drugs & Organics Ltd and Dolutegravir (sodium) (WHOAPI-302) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd have been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.

WHOAPI-302 - Dolutegravir (sodium) - Shanghai Desano Chemical Pharmaceutical Co Ltd - CHINA
- FPPs containing dolutegravir are used in the therapeutic area of HIV/AIDS
WHOAPI-318 - Efavirenz - Mangalam Drugs & Organics Ltd - INDIA
- FPPs containing efavirenz are used in the therapeutic area of HIV/AIDS

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).

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.

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