Solara Completes US FDA Inspection at Mangalore Facility
Filing Summary
Solara Active Pharma Sciences Ltd has announced the successful completion of a US FDA inspection at its Mangalore facility. The inspection, conducted from August 25 to 29, 2025, resulted in an Establishment Inspection Report (EIR) with a “Voluntary Action Indicated” (VAI) classification. The facility, which manufactures active pharmaceutical ingredients (APIs), continues to comply with current Good Manufacturing Practices (cGMP). Solara’s focus remains on maintaining compliance across its manufacturing sites. The Mangalore facility is inspected by multiple regulatory authorities, including US FDA, EDQM, and others.
Solara Active Pharma Sciences Ltd has informed the exchange about the successful completion of a US FDA inspection at its Mangalore facility. The inspection took place from August 25 to 29, 2025. The US FDA issued an Establishment Inspection Report (EIR) on November 18, 2025, classifying the inspection as “Voluntary Action Indicated” (VAI). This classification indicates that the facility remains in compliance with current Good Manufacturing Practices (cGMP).
The filing does not provide specific financial terms or amounts related to the inspection. The focus of the announcement is on regulatory compliance and the successful closure of the inspection process. There are no details regarding payment structures or financial impact in the document.
The Mangalore facility is a multi-product manufacturing site for active pharmaceutical ingredients (APIs). It is equipped with several independent production blocks and related packaging sections. The facility is inspected by various regulatory authorities, including the US FDA, European Directorate for the Quality of Medicines (EDQM), Health Products Regulatory Authority (HPRA), Therapeutic Goods Administration (TGA), World Health Organization (WHO), Pharmaceuticals and Medical Devices Agency (PMDA), and Ministry of Food and Drug Safety (MFDS) of Korea.
The inspection resulted in two Form FDA 483 inspectional observations, which were procedural in nature. Solara submitted a formal response to the US FDA within the timeline set by the agency. The US FDA’s issuance of the EIR and the closure of the inspection reflect Solara’s adherence to regulatory standards. The company emphasizes its commitment to maintaining high compliance levels across its global manufacturing sites.
The inspection at the Mangalore facility was conducted between August 25 and 29, 2025. The US FDA issued the EIR on November 18, 2025, concluding the inspection process. Solara’s management, including Managing Director and CEO Sandeep Rao, has acknowledged the procedural observations and the company’s timely response to the US FDA.
Solara Active Pharma Sciences Ltd is a global manufacturer of active pharmaceutical ingredients (APIs) with a focus on regulatory compliance and quality. The company operates six manufacturing facilities and an R&D center, offering a range of commercial APIs and contract manufacturing services. Solara’s facilities are approved by various international regulatory agencies, including the US FDA, EDQM, and others.