By: IPP Bureau
Last updated : April 22, 2026 5:17 pm
Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States
Supriya Lifescience Limited, a leading API manufacturer, has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) classification from the United States Drug Administration (USFDA) 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 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."
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 (Rs 696 Crore) derived from international markets including the United States.