Supriya Lifescience Wins US FDA VAI for API Manufacturing Unit

Supriya Lifescience Limited has received a major regulatory boost as the U.S. Food and Drug Administration issued an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification for its API manufacturing unit in Lote Parshuram, Maharashtra.

The Supriya Lifescience US FDA VAI outcome marks the successful closure of its latest inspection cycle. The inspection was carried out from February 2 to February 6, 2026. At the end of the process, the US FDA issued a Form 483 with a single minor observation.

The company responded within the required timeline with a detailed explanation, leading to the VAI classification. This result confirms continued adherence to current Good Manufacturing Practices (cGMP) and builds on the facility’s history of prior VAI and No Action Indicated (NAI) outcomes.

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The Supriya Lifescience US FDA VAI status ensures uninterrupted supply of active pharmaceutical ingredients to key regulated markets, including the United States, Europe, and Japan—critical for the company’s export-driven operations.

Dr. Satish Wagh, Executive Chairman & Whole Time Director, Supriya Lifescience Limited, 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 remains central to operations, contributing to a strong global presence. In FY25, 81% of revenue, totaling Rs 696 crore, came from international markets, with the US playing a major role.

Founded in 1987 and headquartered in Mumbai, the company continues to strengthen compliance systems while expanding its footprint across regulated markets.