Solara Active Pharma Sciences has successfully completed a U.S. Food and Drug Administration (FDA) inspection at its Mangalore manufacturing facility, maintaining its Current Good Manufacturing Practice (CGMP) compliance status. This development ensures continued regulatory approval for the company's pharmaceutical manufacturing operations at the facility.

Inspection Details

The FDA inspection, conducted from August 25th to 29th, 2025, resulted in the issuance of an Establishment Inspection Report (EIR) on November 18th, 2025. The inspection classification for the facility was determined to be "Voluntary Action Indicated (VAI)," and the inspection was concluded as closed.

Key Highlights

• The FDA issued two Form 483 inspectional observations, which were procedural in nature.
• Solara submitted a formal response to the FDA within the specified timeline.
• The successful inspection outcome demonstrates Solara's commitment to regulatory excellence and world-class quality standards.

Management Commentary

Sandeep Rao, MD & CEO of Solara Active Pharma Sciences, commented on the inspection outcome: "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."

Facility Overview

The Mangalore facility is a multi-product API manufacturing site equipped with:

• Several independent production blocks
• Related packaging sections
• Approvals from various regulatory authorities including US FDA, EDQM, HPRA, TGA, WHO, PMDA, and MFDS, Korea

This successful FDA inspection reinforces Solara Active's position as a leading pure-play Active Pharmaceutical Ingredient (API) provider, supporting its growth strategy in the global pharmaceutical market.

About Solara Active Pharma Sciences Ltd

Solara Active Pharma Sciences Ltd is a pure-play global API manufacturer with:

• 6 manufacturing facilities
• 1 R&D Centre
• A diverse portfolio of high-value Commercial APIs
• Contract manufacturing services

The company's API facilities are approved by various international regulatory agencies, positioning it strongly in the pharmaceutical industry.

Solara Active Pharma Sciences Ltd. , a prominent player in the Active Pharmaceutical Ingredient (API) sector, has reported a net loss of 101 million rupees for the second quarter, marking a significant shift from the 80 million rupees profit recorded in the same period last year.

Financial Highlights

The company's financial performance for Q2 showed several key changes:

Operational Challenges

The company attributed the decline in performance primarily to short-term disruptions, notably an unscheduled operational shutdown at its Mangalore facility for upgradation purposes. This event led to delayed deliveries and reduced sales volumes during the quarter.

Market Focus

Despite the challenges, Solara maintained its focus on regulated markets, which constituted 75% of total revenues in the current quarter, compared to 76% in the same quarter of the previous year. This strategic emphasis on high-value markets underscores the company's commitment to quality and compliance.

Management Commentary

Sandeep Rao, MD & CEO of Solara Active Pharma Sciences, commented on the results: "While our transformation journey remains intact, our financial performance during this quarter was primarily impacted by short-term disruptions arising from an unscheduled operational shutdown at Mangalore on account of facility upgradation resulting in delayed deliveries and reduced sales volumes during the quarter."

He further added, "The underlying fundamentals of the business remain strong, supported by a resilient operating model, robust compliance framework, and a diversified portfolio across key markets."

Balance Sheet Management

The company is actively working to strengthen its balance sheet, aiming to reduce debt through a combination of rights issues and operating leverage. As of the end of the current quarter, Solara's gross debt stood at 6,233 million rupees, down from 7,760 million rupees at the end of the previous fiscal year.

Future Outlook

While the current quarter results were affected by temporary factors, Solara's management remains confident in the company's long-term prospects. The focus on high-margin segments, cost optimization, and a strong presence in regulated markets is expected to drive future growth and profitability.

Investors and stakeholders will be watching closely to see how Solara navigates these short-term challenges and capitalizes on its strategic initiatives in the coming quarters.