Solara Active Pharma's Mangalore Plant Secures US FDA Nod

Solara Active Pharma Sciences Limited has announced that its multi-product API plant in Mangalore, Karnataka has cleared a recent US FDA inspection.

The review took place from August 25 to 29, 2025, and the company confirmed today that the Agency has issued an Establishment Inspection Report (EIR) dated November 18, 2025, classifying the site as Voluntary Action Indicated (VAI) and closing the inspection.

Commenting on the Inspection Outcome, Sandeep Rao, MD & CEO said "We have successfully completed the FDA inspection at our Mangalore facility between 25th to 29th Aug 2025. At the end of the inspection, two Form FDA 483 inspectional observations were issued by the investigator. The observations were procedural in nature.”

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“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," he added.

The update adds momentum to Solara’s position as a pure play API provider, as a VAI classification confirms that the facility can keep operating without further immediate regulatory steps. This is significant for industry stakeholders who rely on consistent quality and steady supply.

The Mangalore plant is built to support varied API output, with multiple dedicated production blocks and packaging areas. It has also undergone reviews by several global agencies, including US FDA, EDQM, HPRA, TGA, WHO, PMDA and Korea’s MFDS.