Newly prequalified Active Pharmaceutical Ingredients (APIs)

News

11 June, 2019 - 14:00 (CEST)

Daclatasvir (dihydrochloride) (WHOAPI-335) manufactured by Laurus Labs Limited, dolutegravir (sodium) (WHOAPI-354) manufactured by Sun Pharmaceutical Industries Limited and lopinavir (WHOAPI-363) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd have been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.

WHOAPI-335 - Daclatasvir (dihydrochloride) - Laurus Labs Limited - INDIA
- FPPs containing daclatasvir (dihydrochloride) are used in the therapeutic area of hepatitis
WHOAPI-354 - Dolutegravir (sodium) - Sun Pharmaceutical Industries Limited - INDIA
- FPPs containing dolutegravir (sodium) are used in the therapeutic area of HIV/AIDS
WHOAPI-363 - Lopinavir - Shanghai Desano Chemical Pharmaceutical Co Ltd - CHINA
- FPPs containing lopinavir 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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