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WHO prequalifies antiparasitic API Posted 06/12/2019

The World Health Organization (WHO) has announced the prequalification of Pyrimethamine, manufactured by Macleods Pharmaceuticals Ltd, as an active pharmaceutical ingredient (API).

WHO announced in October 2019 that pyrimethamine (WHOAPI-371) has been prequalified by the WHO Prequalification Team as an API.

WHO performs prequalification of APIs to assist in the production of high quality medicines. Its process consists of a comprehensive evaluation, including checking the API Master File to assure compliance with WHO standards and assessing manufacturing sites to confirm good manufacturing practice (GMP) standards are being met.

Pyrimethamine is a small molecule drug used to treat parasitic diseases including toxoplasmosis. It is typically given with follinic acid to reduce toxic effects.

Pyrimethamine has been prequalified by WHO for use in finished pharmaceutical products for the treatment of malaria. The prequalified product is produced by India-based Macleods Pharmaceuticals.

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Source: World Health Organization

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