Newly prequalified Active Pharmaceutical Ingredient (API)

News

16 December, 2019 - 02:00 (CET)

Pyrimethamine (WHOAPI-360) manufactured by Mangalam Drugs & Organics Ltd has been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.

WHOAPI-360 - Pyrimethamine - Mangalam Drugs & Organics Ltd - INDIA
- FPPs containing pyrimethamine 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 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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First products for Ebola Virus Disease prequalified

WHO Prequalification Unit (PQT) added the below new products to its prequalified list: BT-EB001 - Atoltivimab/Maftivimab/Odesivimab - 16.67mg/mL/16.67mg/mL/16.67mg/mL - Solution for infusion - Regeneron Pharmaceuticals Inc - UNITED STATES   BT-EB002 - Atoltivimab/Maftivimab/Odesivimab - 33.33mg/mL/33.33mg/mL/33.33mg/mL - Solution for infusion - Regeneron Pharmaceuticals Inc - UNITED STATES