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REGULATORY UPDATE
Mylan’s Bedaquiline 100mg tablet prequalified
Published: 5/8/2026Detected: 4/10/2026

Summary preview

Adds Mylan’s bedaquiline fumarate 100 mg tablet (TB408, INDIA) to the WHO Prequalified list, enabling eligible countries/programs to procure a WHO-prequalified version for tuberculosis treatment.

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infectious_disease
manufacturing
quality
clinical
safety
labeling
#WHO prequalification
#PQT
#bedaquiline
#tuberculosis
#solid oral dosage form

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  • PQ Webinar: Launch of WHO Prequalification of Medical Devices10/2/2026
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