
Solara Active Pharma Sciences Successfully Completes US FDA Inspection of Mangalore Facility
Solara Active Pharma Sciences Limited, a leading pure play Active Pharmaceutical Ingredient provider, has successfully completed the US FDA inspection of its Mangalore facility. The inspection was carried out between 25th to 29th August 2025 and the Agency has issued an EIR (Establishment Inspection Report) on 18th November 2025, concluding the inspection as closed with a classification of 'Voluntary Action Indicated (VAI)'. The Mangalore facility is well equipped with appropriate infrastructure and is inspected by various Regulatory Authorities including US FDA, EDQM, HPRA, TGA, WHO, PMDA, and MFDS, Korea. Solara continues to maintain the highest level of compliance across its manufacturing facilities, with this inspection outcome demonstrating its commitment to regulatory excellence and world-class quality and compliance.
Key Highlights
- Solara Active Pharma Sciences Limited has successfully completed the US FDA inspection of its Mangalore facility
- The inspection was carried out between 25th to 29th August 2025 and the Agency has issued an EIR on 18th November 2025
- The inspection classification of the facility is ‘Voluntary Action Indicated (VAI)’ and the inspection is closed
- The Mangalore facility is well equipped with appropriate infrastructure and is inspected by various Regulatory Authorities
- This inspection outcome demonstrates Solara's commitment to regulatory excellence and world-class quality and compliance