Solara Active Pharma Sciences Mangalore facility successfully completes USFDA inspection

Published On 2025-11-19 07:33 GMT | Update On 2025-11-19 07:33 GMT

Chennai: Solara Active Pharma Sciences Limited, an Active Pharmaceutical Ingredient provider, has announced that its multi-product manufacturing facility at Mangalore, Karnataka has successfully completed an inspection by the US Food and Drug Administration (US FDA). The inspection was carried out between 25th to 29th Aug 2025.

The Agency has issued an EIR (Establishment Inspection Report) 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.

Read also: USFDA successfully completes inspection at Solara Ambernath facility

Solara Active Pharma Sciences Ltd is a global API manufacturer supported by state-of-the-art R&D and manufacturing facilities. With 6 manufacturing facilities and an R&D Centre, Solara offers a basket of diversified, high-value Commercial APIs and Contract manufacturing services. Its API facilities are approved by various international regulatory agencies including the USFDA, EDQM, MFDS, WHO, PMDA etc.

Read also: Ex-Viatris Chief Sandeep Rao joins Solara Active Pharma Sciences as MD, CEO

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Solara Active Pharma Sciences Mangalore facility successfully completes USFDA inspection

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