Bangalore, India, June 10, 2025 — OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE), a multi-modality specialty pharma pure-play CDMO, announced that its flagship facility in Bangalore, India, has received a “Voluntary Action Indicated” (VAI) classification from the U.S. Food and Drug Administration (USFDA), confirming its continued compliance.
Following an inspection of the company’s flagship facility from March 20 to March 28, 2025, the USFDA 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, said “The successful closure of our latest USFDA 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.”
About OneSource Specialty Pharma Limited
OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five state-of-the-art manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,200 professionals. OneSource with its development capabilities, industry leading manufacturing capacities, and strong compliance track record, has won trust of global pharmaceutical companies seeking efficient, end-to-end solutions. For more information, please visit www.onesourcecdmo.com.
For further information, please contact:
| Institutional Investors Anurag Bhagania CFO Tejaswani Fotedar Email: investor-relations@onesourcecdmo.com | Corporate Communication Pallavi Panchmatia: +91 8951939181 Abhilash Mukherjee: +9189044 28907 Email: corpcomm@onesourcecdmo.com PR Consultancy Adfactors PR Janhavi Bellare: +91 93228 54508 Email: Janhavi.bellare@adfactorspr.com Syed Talal: +91 99876 19679 Email: syed.talal@adfactorspr.com |
