The facility received a "Voluntary Action Indicated" (VAI) classification from the USFDA, following an inspection conducted between March 20 and March 28, 2025. During the inspection, the agency issued a Form 483 with four observations. However, after reviewing the company's comprehensive response and commitments, the agency has officially closed 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."
OneSource Specialty Pharma 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 manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,200 professionals.
On a consolidated basis, OneSource Specialty Pharma reported net profit of Rs 98.50 crore in Q4 March 2025 as against net loss of Rs 40.17 crore in Q4 March 2024. Net sales surged 482.38% YoY to Rs 425.95 crore in Q4 March 2025.