Aurobindo Pharma Limited has issued a formal clarification to stock exchanges regarding recent news reports about a US FDA inspection, reaffirming its commitment to regulatory compliance and transparent disclosure practices.

Stock Exchange Communication

The pharmaceutical company responded to specific queries from both the National Stock Exchange of India Limited and BSE Limited on February 18, 2026. The exchanges had sought clarifications regarding news items appearing on NDTV Profit's website concerning the US FDA inspection.

FDA Inspection Status Update

The company clarified that it had previously informed stock exchanges on February 10, 2026, regarding the completion of the US FDA inspection at Unit-VII of Aurobindo Pharma Ltd. The company confirmed its commitment to responding to the US FDA within the stipulated timelines as part of standard regulatory procedures.

Aurobindo Pharma emphasized that it has been making timely and adequate disclosures of all material events and information to stock exchanges in strict compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Regulatory Compliance Framework

The company highlighted that routine regulatory inspections across its manufacturing facilities by global regulatory authorities, including the USFDA, are part of normal business operations. Any observations issued during such inspections are addressed in accordance with established regulatory processes.

Key compliance aspects mentioned:

• Timely disclosure of material events under SEBI LODR Regulations
• Routine regulatory inspections as standard business practice
• Appropriate responses to regulatory observations
• Transparent communication with stock exchanges

Current Disclosure Status

Aurobindo Pharma stated that at present, there is no material event or information that requires further disclosure under Regulation 30 of the SEBI LODR Regulations, other than what has already been disclosed to the exchanges. The company requested that the exchanges take this clarification on record.

The clarification was signed by B. Adi Reddy, Company Secretary, and submitted digitally on February 18, 2026, demonstrating the company's prompt response to regulatory queries and commitment to maintaining transparency with stakeholders.

Aurobindo Pharma delivered a strong financial performance in the third quarter of FY26, demonstrating sustained business momentum across its global operations. The pharmaceutical company reported consolidated revenue growth of 8.4% year-on-year, reaching Rs. 8,646 crores, while maintaining robust profitability metrics.

Financial Performance Highlights

The company's financial metrics reflected strong operational execution during the quarter. EBITDA stood at Rs. 1,773 crores with a margin of 20.5%, representing a 9% year-on-year growth. Net profit for the period reached Rs. 910 crores, after accounting for a one-time cost of Rs. 65 crores due to changes in labor code amendments.

Business Segment Performance

Formulations Business

The formulation business emerged as the primary growth driver, contributing Rs. 7,683 crores and representing approximately 89% of total consolidated revenue. This segment achieved a 10% year-on-year growth, supported by strong performance across multiple geographic markets.

European Operations Lead Growth

European business maintained exceptional momentum, delivering 27% year-on-year revenue growth to Rs. 2,703 crores (EUR 261 million). The company's consistent execution across key European markets, including France, Portugal, Germany, and Netherlands, all showed double-digit growth rates. Management expressed confidence in exceeding EUR 1 billion in annual European revenue by the close of FY26.

US Market Performance

US formulation revenue reached USD 420 million during the quarter. Excluding generic Revlimid, the US oral solid business remained stable, demonstrating resilience through its diversified product portfolio. The US injectable sales segment showed particular strength with 17% year-on-year growth. The company launched 9 new products and received 7 approvals during the quarter, reflecting robust pipeline performance.

Growth Markets and ARV Formulations

Revenue from growth markets remained stable at Rs. 865 crores (USD 97 million), supported by steady volumes and a diversified commercial base across strategic markets. The ARV formulation segment achieved Rs. 376 crores (USD 42 million) with 22% year-on-year growth, driven by higher volumes and new tender wins.

Strategic Developments

Pen-G Facility Progress

The company's Pen-G manufacturing facility showed significant operational improvements, with production ramping up to approximately 10,000 metric tonnes on an annualized basis. The Government of India's introduction of a one-year minimum import price (MIP) for Pen-G, 6-APA, and Amoxicillin represents a positive catalyst for the company's antibiotic manufacturing operations.

Manufacturing and Regulatory Updates

The Dayton facility successfully transitioned into commercial phase with manufacturing underway, expected to contribute significantly to revenues from FY27 onwards. The Raleigh facility remains on track pending regulatory clearance. The company's China OSD facility continues progressing toward 2 billion units annual capacity, supported by EU approval for 10 products and 3 local product approvals.

Operational Metrics

R&D expenditure stood at Rs. 409 crores, representing 5% of total revenues, reinforcing the company's commitment to building a robust pipeline of high-value products. Net capex for the quarter reached USD 79 million, aligned with strategic priorities of enhancing manufacturing capabilities and strengthening compliance. The company generated net cash inflow of USD 118 million during the quarter, improving its net cash position to USD 251 million as of December 31, 2025.

Future Outlook

Management expressed confidence in sustaining growth momentum across all business segments, supported by the company's diversified operating model and expanding manufacturing footprint. The company targets achieving EBITDA margins on the higher side of 20% to 21% for FY26, with several growth initiatives providing strong earnings visibility over the medium to long term.