Solara announces successful closure of US FDA inspection of its Puducherry Facility with continued state of cGMP compliance

Solara Active Pharma Sciences Limited (Solara), a leading pure play Active Pharmaceutical Ingredient manufacturer is pleased to announce that its Ibuprofen manufacturing facility at Puducherry has successfully completed the Unannounced inspection carried out by the US Food and Drug Administration (US FDA) between 2nd to 6th Feb 2026. Based on the response submitted, within the stipulated timeline to the Agency, against the observations cited during the inspection, the Agency has issued an EIR (Establishment Inspection Report) on April 24, 2026 with inspection classification of the facility as "Voluntary Action Indicated (VAI)" and concluded this inspection as "Closed".

Solara continues to stay focused on maintaining the highest level of Quality Compliance across its manufacturing facilities.

Commenting on the Inspection Outcome, Sandeep Rao, MD & CEO said "We have successfully completed the FDA inspection at our Puducherry facility between 2nd to 6th Feb 2026. At the end of the inspection, four Form FDA 483 inspectional observations were issued by the investigator. The observations were procedural in nature. We had submitted our formal response to FDA well within the timeline set by the Agency and the Agency has issued an EIR and concluded that the inspection is closed. The inspection outcome demonstrates our commitment to regulatory excellence at our global manufacturing sites and relentless focus on world-class quality and compliance, which remains a key pillar of our growth strategy."

The successful outcome of the unannounced USFDA inspection at our facility exhibits our dedication to achieving Quality excellence consistently at all our manufacturing sites and our commitment to focus on world-class Quality and Regulatory Compliance, which remains a key pillar of our growth strategy.

The Puducherry site, an Ibuprofen manufacturing facility of Solara, is well equipped with world class infrastructure to cater to Ibuprofen & its derivatives requirements for the domestic and international markets. This site is inspected by various Regulatory Authorities including US FDA, EDQM, MHRA & HPRA.

Shares of Solara Active Pharma Sciences Limited was last trading in BSE at Rs. 478.75 as compared to the previous close of Rs. 483.95. The total number of shares traded during the day was 8234 in over 395 trades.

The stock hit an intraday high of Rs. 488.60 and intraday low of 476.55. The net turnover during the day was Rs. 3973715.00.

Source : Equity Bulls

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