Biocon Limited has notified stock exchanges about receiving a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration for one of its API manufacturing facilities. The pharmaceutical company disclosed this regulatory development through official communications to both major Indian stock exchanges on January 28, 2026.

Facility Details and Inspection Timeline

The VAI status pertains to Biocon's API facility situated at a specific location in Andhra Pradesh. The US FDA conducted its inspection over a five-day period, providing a comprehensive assessment of the manufacturing operations.

Regulatory Compliance and Disclosure

Biocon has fulfilled its disclosure obligations by informing both BSE Limited and National Stock Exchange of India Limited about this regulatory development. The company's notification was signed by Rajesh Umakant Shanoy, Company Secretary and Compliance Officer, ensuring proper corporate governance protocols were followed.

The pharmaceutical company has also made this information available on its official website at www.biocon.com , providing transparency to all stakeholders. This disclosure falls under Regulation 30 requirements, which mandate listed companies to inform exchanges about material events that could impact investor decisions.

Communication to Stock Exchanges

The formal notification was addressed to both major Indian stock exchanges with specific reference numbers for tracking purposes.

The company has requested both exchanges to acknowledge receipt of this notification and maintain it on record as part of standard compliance procedures.

Biocon Biologics Limited, a subsidiary of Biocon Limited, has received a significant credit rating upgrade from S&P Global Ratings, marking a positive milestone in the company's financial restructuring efforts. The rating agency upgraded the company's long-term issuer credit rating to 'BB+' from 'BB' and revised the outlook to stable on January 28, 2026.

Capital Structure Simplification Drives Upgrade

The upgrade primarily stems from Biocon's successful capital structure simplification through recent equity transactions. The company utilized fresh equity proceeds to settle a US$1 billion compulsorily convertible preference shares (CCPS) arrangement with Viatris Inc. through a combination of equity share swaps and cash consideration.

S&P estimates that Biocon's adjusted debt will decline significantly to approximately INR115 billion at the end of fiscal 2026, down from INR248 billion in fiscal 2025. This substantial reduction reflects the removal of structured debt liabilities and the CCPS obligations that were previously considered debt-like instruments in financial ratio calculations.

Improved Financial Metrics and Outlook

The rating agency projects substantial improvements in Biocon's key financial ratios following the capital restructuring. The funds from operations (FFO) to debt ratio is expected to improve dramatically to about 22% at the end of fiscal 2026 from less than 10% in the previous year, with further improvement to approximately 30% by fiscal 2027.

S&P highlighted that new product launches and favorable industry trends will support Biocon's earnings growth. The pharmaceutical sector is expected to register healthy growth through 2027, particularly for GLP-1s and treatments for oncology and rare diseases.

Business Fundamentals and Growth Drivers

Biocon's revenue growth will be led by its biosimilars business, which S&P estimates will grow by approximately 15% in fiscal 2027. The scale-up and market share gains of new products bStelara and Aflibercept are expected to offset price erosion effects inherent to the generics industry. The company plans to launch at least one new product, Denosumab, during this period.

Key Business Highlights:

• 10 commercialized biosimilars currently in portfolio
• Pipeline of 20+ biosimilar assets across multiple therapeutic areas
• High single-digit to low double-digit market share in U.S. and European markets
• Serving over 6.3 million patients across 120+ countries

The company's generics and contract research development and manufacturing organization (CRDMO) business segments are also expected to expand steadily, with generics growing by about 10% led by new product launches such as Liraglutide in the U.K. and EU markets.

Strategic Positioning and Market Presence

Biocon Biologics operates as a fully integrated global biosimilars company with comprehensive 'lab to market' capabilities. The company maintains eight manufacturing sites globally - six in India, one in Malaysia, and one in the United States. Geographically, the U.S. and EU markets accounted for 46% and 25% respectively of group revenues in fiscal 2025.

The stable outlook reflects S&P's view that Biocon's earnings will grow steadily over the next 12-24 months, supported by growing demand for generics and biosimilars in key international markets and successful new product launches. This growth trajectory should help maintain the company's improved financial position and support further ratio improvements.