Newly prequalified Active Pharmaceutical Ingredients (APIs)

News

20 September, 2017 - 04:00 (CEST)

Lamivudine (WHOAPI-265) manufactured by Anhui Biochem United Pharmaceutical Co Ltd and Praziquantel (WHOAPI-301) manufactured by Hisun Pharmaceutical (Nantong) Co Ltd have been prequalified by the WHO Prequalification Team: medicines (PQTm) under its active pharmaceutical ingredient (API) prequalification procedure.

WHOAPI-265 - Lamivudine - Anhui Biochem United Pharmaceutical Co Ltd - CHINA
- FPPs containing lamivudine are used in the therapeutic area of HIV/AIDS
WHOAPI-301 - Praziquantel - Hisun Pharmaceutical (Nantong) Co Ltd - CHINA
- FPPs containing praziquantel are used in the therapeutic area of Neglected Tropical Diseases (NTD). This is the first praziquantel API to be prequalified.

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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