Solara's Puducherry facility successfully clears US FDA inspection

Solara Active Pharma Sciences announced the successful closure of the US FDA inspection of its Ibuprofen manufacturing facility at Puducherry. The unannounced inspection, conducted from February 2-6, 2026, initially resulted in four procedural Form FDA 483 observations. Following Solara's timely response, the US FDA issued an Establishment Inspection Report (EIR) on April 24, 2026, classifying the inspection as "Voluntary Action Indicated (VAI)" and concluding it as "Closed." MD & CEO Sandeep Rao highlighted that this outcome underscores the company's commitment to regulatory excellence and world-class quality compliance across its manufacturing sites, a key pillar of its growth strategy. The Puducherry facility is crucial for catering to Ibuprofen and its derivatives requirements for domestic and international markets.