Solara Announces Successful Closure of US FDA Inspection at Puducherry Facility
Chennai, India, April 28, 2026: Solara Active Pharma Sciences Limited (Solara), a prominent pure play Active Pharmaceutical Ingredient manufacturer, has announced the successful conclusion of a US Food and Drug Administration (US FDA) inspection at its Puducherry Ibuprofen manufacturing facility.The unannounced inspection was carried out by the US FDA between February 2 and February 6, 2026. Following the submission of the company’s formal response to observations cited during the inspection, the Agency issued an Establishment Inspection Report (EIR) on April 24, 2026. The inspection classified the facility as 'Voluntary Action Indicated (VAI)' and officially concluded the process as 'Closed'.
Solara stated that the successful outcome demonstrates the company's continued state of cGMP compliance and its commitment to maintaining the highest level of quality compliance across its manufacturing sites.
Sandeep Rao, MD & CEO, commented on the outcome, noting that while four Form FDA 483 inspectional observations were issued by the investigator, these observations were procedural in nature. He highlighted that the subsequent formal response was submitted to the FDA well within the stipulated timeline set by the Agency.
The company emphasized that the outcome underscores its dedication to achieving quality excellence and its continued focus on world-class quality and regulatory compliance, which remains a key pillar of its growth strategy.
The Puducherry site is a key Ibuprofen manufacturing facility equipped with world-class infrastructure designed to meet requirements for Ibuprofen and its derivatives for both domestic and international markets. This site has been inspected by various major regulatory bodies, including the US FDA, EDQM, MHRA, and HPRA.
About Solara Active Pharma Sciences Ltd
Solara Active Pharma Sciences Ltd is a global pure play API manufacturer. The company operates six manufacturing facilities and an R&D Centre, offering a diverse basket of high-value Commercial APIs and Contract manufacturing services. Its API facilities are approved by multiple international regulatory agencies, including the USFDA, EDQM, MFDS, WHO, HPRA, and PMDA.
SOLARA Stock Price Movement
Today, Solara Active Pharma Sciences Limited shares slipped by 0.29% to settle at ₹478.15. The stock closed amid a day of trading, recording a total volume of 64,978 shares.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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