Biocon Limited has announced a significant regulatory milestone with its wholly-owned subsidiary Biocon Pharma Limited receiving approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Liraglutide Injection. The company disclosed this development through a formal notification to stock exchanges on March 12, 2026.

Product Specifications and Indication

The approved ANDA covers Liraglutide Injection (gVictoza®) in a specific formulation designed for diabetes management. The product details are outlined below:

Liraglutide is specifically indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus, providing healthcare providers with another therapeutic option for managing this chronic condition across multiple age groups.

Strategic Portfolio Enhancement

This latest FDA approval represents the second Liraglutide-based product approval for Biocon in recent weeks. The company previously received approval for Liraglutide injection (gSaxenda®) on February 24, 2026, demonstrating consistent regulatory success in this therapeutic area.

The dual approvals are expected to strengthen Biocon's portfolio of vertically integrated, complex drug products, positioning the company to better serve the diabetes treatment market in the United States. The complex nature of these injectable formulations aligns with Biocon's expertise in developing sophisticated pharmaceutical products and enhances its competitive positioning in the specialty therapeutics segment.

Regulatory Compliance and Disclosure

Biocon Limited fulfilled its regulatory disclosure obligations by notifying both major Indian stock exchanges about this development. The company submitted formal notifications to BSE Limited and the National Stock Exchange of India Limited, ensuring transparency with stakeholders and compliance with listing requirements.

The notification was signed by Rajesh Umakant Shanoy, Company Secretary and Compliance Officer, and the information has been made available on the company's official website at www.biocon.com for broader stakeholder access.

Biocon Limited has delivered a strong financial performance in the third quarter of FY26, demonstrating robust revenue growth and significant improvement in profitability metrics. The biotechnology major's consolidated results reflect the company's continued operational strength across its diversified business portfolio.

Consolidated Financial Performance

The company's consolidated operations showed impressive momentum during Q3FY26. Revenue from operations increased by 9.2% year-over-year, rising from ₹38,214 million in Q3FY25 to ₹41,730 million in Q3FY26. This growth trajectory underscores the company's ability to expand its market presence and capitalize on emerging opportunities in the biotechnology sector.

Nine-Month Performance Overview

For the nine months ended December 31, 2025, Biocon's consolidated revenue reached ₹1,24,104 million, while net profit attributable to shareholders stood at ₹2,597 million. The nine-month basic earnings per share was ₹2.01, reflecting the company's sustained profitability improvements throughout the fiscal year.

Standalone Operations Analysis

The standalone financial results present a mixed picture, with revenue from operations at ₹6,213 million for Q3FY26 compared to ₹5,628 million in Q3FY25. However, the standalone operations reported a loss before tax of ₹845 million and a net loss of ₹764 million for the quarter. For the nine-month period, standalone revenue was ₹17,417 million with a net loss of ₹138 million.

Capital Structure and Share Performance

Biocon's paid-up equity share capital stood at ₹6,685 million as of December 31, 2025, with each share having a face value of ₹5. The significant improvement in earnings per share from ₹0.21 to ₹1.08 demonstrates enhanced shareholder value creation during the quarter.

Regulatory Compliance and Governance

The unaudited financial results were reviewed by the Audit Committee and approved by the Board of Directors at their meetings held on February 11, 2026, and February 12, 2026. The results have been prepared in accordance with Indian Accounting Standards (Ind AS) prescribed under Section 133 of the Companies Act, 2013, and comply with Regulation 33 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

The detailed financial results are available on stock exchange websites www.bseindia.com and www.nseindia.com , as well as on the company's investor relations website at www.biocon.com/investor-relations .