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OneSource Specialty Pharma, a multi-modality specialty pharma pure-play CDMO, announced that its flagship facility in Bengaluru, India, has received a ‘Voluntary Action Indicated’ (VAI) classification from the US Food and Drug Administration (FDA), confirming its continued compliance.
Following an inspection of the company's flagship facility from March 20 to March 28, 2025, the US FDA issued a Form 483 with four observations. Based on the company's comprehensive response and commitments, the agency has classified the inspection outcome as Voluntary Action Indicated (VAI), officially closing the inspection.
Neeraj Sharma, managing director & CEO, OneSource Specialty Pharma said "The successful closure of our latest US FDA inspection is a pivotal moment in our journey, and we are very pleased with this outcome demonstrating our exemplary compliance status. Our flagship facility, Unit 2, is the cornerstone of our manufacturing capabilities in drug device combinations (DDC), biologics drug substances, and complex injectables. This milestone validates our deep-rooted commitment to quality and is crucial as our partners prepare to launch key GLP-1 products in late FY26. We are excited to advance into our next significant commercial phase.”
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