Solara Active Pharma Sciences Limited has informed the Exchange regarding the press release dated April 28, 2026, titled Solara is pleased to announce the successful closure of US FDA inspection of its Puducherry Facility with continued state of cGMP compliance.
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Solara Active Pharma Sciences has announced the successful closure of a US FDA inspection at its Ibuprofen manufacturing facility in Puducherry. The unannounced inspection took place from February 2-6, 2026. During the inspection, four Form FDA 483 observations were issued, which the company states were procedural in nature. Solara submitted its response within the timeline set by the agency. The FDA issued the Establishment Inspection Report (EIR) on April 24, 2026, classifying the inspection as 'Voluntary Action Indicated (VAI)' and closed it. The facility maintains its cGMP (Current Good Manufacturing Practice) compliance status. The Puducherry site is also approved by EDQM, MHRA, and HPRA regulatory authorities.
The closure of this FDA inspection with maintained cGMP compliance is positive for the company as it confirms the facility remains authorized to serve the critical US pharmaceutical market. It reinforces the company's regulatory standing and its ability to supply Ibuprofen to both domestic and international customers without disruption.