Shares of Solara Active Pharma Sciences Limited gained over 4% in early trade after the company announced a positive regulatory update from the US Food and Drug Administration regarding its Puducherry manufacturing facility.
The company confirmed that its Ibuprofen manufacturing plant in Puducherry successfully completed an unannounced USFDA inspection conducted between February 2 and February 6, 2026. Following the inspection, the regulator has issued an Establishment Inspection Report (EIR) on April 24, 2026, classifying the facility under “Voluntary Action Indicated (VAI)” and officially closing the inspection.
A VAI classification indicates that while certain observations were noted during the inspection, they were not significant enough to warrant regulatory enforcement action. In this case, the USFDA had issued four Form 483 observations, which were procedural in nature. Solara submitted its response within the stipulated timeline, addressing all concerns raised by the agency.
Commenting on the development, Managing Director and CEO Sandeep Rao stated that the successful closure of the inspection reflects the company’s strong commitment to maintaining global quality standards and regulatory compliance. The outcome reinforces Solara’s focus on operational excellence across its manufacturing network.
The Puducherry facility plays a key role in Solara’s API portfolio, particularly in the production of Ibuprofen and its derivatives for both domestic and international markets. The site is equipped with advanced infrastructure and is regularly inspected by multiple global regulatory authorities, including the USFDA, EDQM, MHRA, and HPRA.