Supriya Lifescience recently announced that the US Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) classification for its Active Pharmaceutical Ingredients (API) facility at Lote Parshuram, Maharashtra. This closes the recent inspection cycle.

The inspection was conducted between February 2 and February 6, 2026. At the conclusion of the inspection, the FDA issued a Form 483 with one minor observation. The company submitted a response within the stipulated timeline. The VAI outcome confirms ongoing cGMP compliance and builds on the site’s prior FDA classifications, including VAI and NAI.

The VAI classification enables the company to continue supply of APIs to regulated markets, including the US, Europe, and Japan.

Speaking in this regard, Dr. Satish Wagh, Executive Chairman and Whole Time Director, Supriya Lifescience, said, “Successful closure of the US FDA 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 and supports its global customer base and export-led growth strategy. In FY25, 81 per cent of revenue (INR 696 crore) was derived from international markets, including the US. The company stated that regulatory compliance at the site is central to supply continuity in regulated markets and its position as a global API supplier.

The company stated that it continues to focus on strengthening its compliance framework, enhancing operational capabilities, and expanding presence in regulated markets as part of its long-term strategy.