Cycloserine manufactured by Zhejiang Hisun Pharmaceutical Co Ltd and Zinc (sulfate) manufactured by Canton Laboratories Pvt Ltd have been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
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WHOAPI-262 - Cycloserine - Zhejiang Hisun Pharmaceutical Co Ltd - CHINA
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FPPs containing cycloserine are used in the therapeutic area of tuberculosis
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WHOAPI-146 - Zinc (sulfate) - Canton Laboratories Pvt Ltd - INDIA
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FPPs containing Zinc (sulfate) are used in the therapeutic area of diarrhoea
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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.