Solara’s Mangalore facility clears FDA inspection with VAI status

Solara Active Pharma Sciences Limited (Solara), a leading pure play API provider has announced that its multi-product manufacturing facility at Mangalore, Karnataka has successfully completed the inspection carried out by the US Food and Drug Administration (US FDA) between 25th to 29th Aug 2025.

The Agency has issued an EIR (Establishment Inspection Report) on 18th Nov 2025 and determined that the inspection classification of the facility is "Voluntary Action Indicated (VAI)" and concluded this inspection as closed.

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. 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 Mangalore multi-product API manufacturing facility is well equipped with appropriate infrastructure to include several independent production blocks and related packaging sections. This site is inspected by various Regulatory Authorities including US FDA, EDQM, HPRA, TGA, WHO, PMDA, and MFDS, Korea.