Solara’s Mangalore Site Clears US FDA Inspection with VAI Status
POWER & RENEWABLE ENERGY

Solara’s Mangalore Site Clears US FDA Inspection with VAI Status

Solara Active Pharma Sciences has announced the successful completion of the US Food and Drug Administration (US FDA) inspection at its multi-product Active Pharmaceutical Ingredient manufacturing facility in Mangalore, Karnataka. The inspection, conducted from 25 to 29 August 2025, concluded with the issuance of an Establishment Inspection Report (EIR) on 18 November 2025. The Agency classified the facility as “Voluntary Action Indicated” (VAI), confirming continued compliance with current Good Manufacturing Practices (cGMP) and formally closing the inspection.

According to the company, the US FDA issued two procedural Form 483 observations at the end of the inspection. Solara submitted a comprehensive response within the stipulated timeframe, following which the Agency acknowledged the adequacy of the corrective actions and closed the inspection. The company noted that the outcome reflects its commitment to regulatory excellence, robust quality systems and adherence to global compliance standards across all manufacturing sites.

The Mangalore facility is equipped with multiple independent production blocks and packaging units, enabling supply of a wide portfolio of APIs. It is also regularly inspected by leading global regulatory bodies, including EDQM, HPRA, TGA, WHO, PMDA and MFDS Korea. Solara stated that maintaining world-class quality and compliance remains central to its long-term growth strategy.

Solara Active Pharma Sciences has announced the successful completion of the US Food and Drug Administration (US FDA) inspection at its multi-product Active Pharmaceutical Ingredient manufacturing facility in Mangalore, Karnataka. The inspection, conducted from 25 to 29 August 2025, concluded with the issuance of an Establishment Inspection Report (EIR) on 18 November 2025. The Agency classified the facility as “Voluntary Action Indicated” (VAI), confirming continued compliance with current Good Manufacturing Practices (cGMP) and formally closing the inspection. According to the company, the US FDA issued two procedural Form 483 observations at the end of the inspection. Solara submitted a comprehensive response within the stipulated timeframe, following which the Agency acknowledged the adequacy of the corrective actions and closed the inspection. The company noted that the outcome reflects its commitment to regulatory excellence, robust quality systems and adherence to global compliance standards across all manufacturing sites. The Mangalore facility is equipped with multiple independent production blocks and packaging units, enabling supply of a wide portfolio of APIs. It is also regularly inspected by leading global regulatory bodies, including EDQM, HPRA, TGA, WHO, PMDA and MFDS Korea. Solara stated that maintaining world-class quality and compliance remains central to its long-term growth strategy.

Next Story
Infrastructure Urban

Panasonic Showcases Connected Display Solutions

Panasonic Life Solutions India showcased its integrated display, projection, broadcast and communication technologies at Panasonic Tech Summit 2026 in New Delhi. Hosted through its System Solutions Division, the two-day event highlighted connected technology solutions for education, healthcare, retail, transportation, corporate offices and entertainment.The summit, themed ‘Turning Technology into Value’, featured experience-led zones covering QSR, retail, transit, corporate offices, healthcare, education, security, projection, home theatre and professional displays. Panasonic also introduc..

Next Story
Infrastructure Transport

Kapsch to Deliver India’s First C-ITS Project

"Kapsch TrafficCom will deliver India’s first Cooperative Intelligent Transport Systems project on a key expressway near New Delhi. The project will be implemented with Superwave Communication And Infrasolution Limited to demonstrate how connected mobility can improve road safety and traffic efficiency.The pilot will use real-time connectivity and AI-enabled situational awareness to support road users, especially in high-risk areas such as temporary work zones. Drivers will receive alerts on roadworks, maintenance vehicles, hazardous locations, traffic queues and temporary virtual signage di..

Next Story
Infrastructure Urban

Eurobond Net Profit Rises 44 Per Cent

Euro Panel Products, the parent company of Eurobond, reported a 44.13 per cent year-on-year rise in net profit for FY25–26. The company’s revenue from operations grew 18.91 per cent to Rs 503.20 crore, compared to Rs 423.18 crore in the previous financial year.The company’s full-year EBITDA stood at Rs 56.67 crore, marking a 31.82 per cent increase. Profit after tax rose to Rs 26.56 crore, while net worth increased 20.15 per cent to Rs 160.07 crore. Earnings per share for the year stood at Rs 10.84.Divyam Rajesh Shah, Whole Time Director and CFO, Euro Panel Products, said the company’s..

Advertisement

Subscribe to Our Newsletter

Get daily newsletters around different themes from Construction world.

STAY CONNECTED

Advertisement

Advertisement

Advertisement

-->