Mumbai, April 22: Supriya Lifescience Limited, a leading API manufacturer, today announced the USFDA has issued an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) classification for its API facility at Lote Parshuram, Maharashtra successfully closing the recent inspection cycle.
The inspection was conducted between February 2 and February 6, 2026. At the conclusion of the inspection, the USFDA issued a Form 483 with one minor observation, to which the company submitted a comprehensive response within the stipulated timeline. This VAI outcome affirms ongoing cGMP compliance, building on the site’s established USFDA track record including prior VAI and NAI classifications.
The VAI classification enables Supriya Lifescience to maintain uninterrupted supplies of APIs to regulated markets such as the United States, Europe, and Japan.
Dr. Satish Wagh, Executive Chairman & Whole Time Director, Supriya Lifescience Supriya Lifescience Limited, said:
“Successful closure of the USFDA inspection with this outcome reflects the strength of our quality systems and our consistent focus on regulatory excellence. It reinforces our position as a reliable API partner for global pharmaceutical companies and strengthens our ability to expand in regulated markets such as the United States. We remain committed to maintaining the highest standards of quality and compliance across all our operations.”
The Lote Parshuram facility is the company’s key manufacturing hub, playing a central role in supporting its global customer base and export-led growth strategy, with 81% of FY25 revenue derived from international markets including the United States. Continued regulatory compliance at this site remains integral to ensuring reliable supply of APIs to highly regulated markets and reinforcing the company’s position as a trusted global partner.
Supriya Lifescience continues to focus on strengthening its compliance framework, enhancing operational capabilities, and expanding its footprint in regulated markets as part of its long-term growth strategy.
