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REGULATORY UPDATE
Active Pharmaceutical Ingredient (API) Prequalified
Published: 10/2/2026Detected: 9/17/2026

Summary preview

WHO prequalification has been granted for bedaquiline (fumarate) manufactured by Arene Life Sciences Private Limited, supporting its availability as a quality-assessed API for use in tuberculosis medicines.

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infectious_disease
manufacturing
quality
#WHO prequalification
#API prequalification
#APIMF
#WHO GMP
#bedaquiline fumarate

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