Newly prequalified Active Pharmaceutical Ingredients (APIs)

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29 June, 2018 - 04:00 (CEST)

Linezolid (WHOAPI-252) and Kanamycin (acid sulfate) (WHOAPI-257) manufactured by Zhejiang Hisun Pharmaceutical Co Ltd and ethambutol hydrochloride (WHOAPI-197) manufactured by Lupin Ltd (Ankleshwar) have been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.

WHOAPI-197 - Ethambutol hydrochloride - Lupin Ltd - INDIA
- FPPs containing ethambutol hydrochloride are used in the therapeutic area of tuberculosis
WHOAPI-252 - Linezolid - Zhejiang Hisun Pharmaceutical Co Ltd - CHINA
- FPPs containing linezolid are used in the therapeutic area of tuberculosis
WHOAPI-257 - Kanamycin (acid sulfate) - Zhejiang Hisun Pharmaceutical Co Ltd - CHINA
- FPPs containing kanamycin (acid sulfate) are used in the therapeutic area of tuberculosis

Good-quality APIs are vital to the production of good-quality medicines. WHO prequalification of APIs facilitates 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 Good Manufacturing Practice requirements.

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