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REGULATORY UPDATE
First Isoniazid/Moxifloxacin (hydrochloride)/Rifapentine FDC tablet product prequalified
Published: 10/2/2026Detected: 9/28/2026

Summary preview

Adds WHO PQT product TB415 (Isoniazid/moxifloxacin hydrochloride/rifapentine FDC tablet) from Lupin, India, to the prequalified list as the first FDC product of its kind.

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infectious_disease
respiratory
manufacturing
quality
clinical
safety
labeling
#WHO prequalification
#tuberculosis
#TB415
#fixed-dose combination

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