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Newly Prequalified Active Pharmaceutical Ingredient (API)

News
22 December, 2016 - 01:00 (CET)
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Medroxyprogesterone manufactured by Taizhou Taifa Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.

  • WHOAPI-244 - Medroxyprogesterone - Taizhou Taifa  Co Ltd - CHINA

    • FPPs containing medroxyprogesterone are used in the therapeutic area of Reproductive Health

Good-quality APIs are vital to the production of good-quality medicines. WHO prequalification of APIs will facilitate 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 GMP requirements.