Levofloxacin manufactured by Shangyu Jingxin Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
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WHOAPI-245 - Levofloxacin - Shangyu Jingxin Pharmaceutical Co Ltd - CHINA - FPPs containing levofloxacin are used in the therapeutic area of tuberculosis
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.