Dihydroartemisinin manufactured by Ipca Laboratories Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
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WHOAPI-233 - Dihydroartemisinin (Artenimol) - Ipca Laboratories Ltd - INDIA
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FPPs containing dihydroartemisinin (Artenimol) are used in the therapeutic area of malaria
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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.