Solara Active Pharma Sciences Limited has received a positive regulatory update for its Mangalore manufacturing site, strengthening its position as a trusted global API supplier. The company confirmed that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) on 18 November 2025, officially closing the inspection that took place between 25 and 29 August 2025. The facility has been classified as “Voluntary Action Indicated (VAI),” which essentially means the plant meets the required regulatory standards and that any observations were minor and do not call for further official action.
According to Solara, the inspection resulted in two procedural observations captured in Form FDA 483. The company responded to these within the stipulated timeline, following which the US FDA accepted its explanation and concluded the review. For Solara, this outcome reinforces its commitment to maintaining strict quality systems and a high level of regulatory compliance across all manufacturing locations.
Managing Director and CEO Sandeep Rao said the successful closure of the inspection reflects Solara’s focus on world-class quality practices and operational excellence. He added that the company views regulatory compliance as a core pillar of its long-term growth strategy, especially as it continues to scale its presence across global markets.
The Mangalore site is one of Solara’s key multi-product API manufacturing facilities and is equipped with multiple dedicated production blocks, packaging units, and modern infrastructure. Over the years, it has been inspected by several major global regulatory authorities including the US FDA, EDQM, HPRA, TGA, WHO, PMDA, and MFDS Korea. This latest clearance further strengthens Solara’s reputation as a reliable, compliant, and globally competitive API manufacturer.
