Concord Biotech Sets Sights on U.S. Expansion After FDA Green Light

Concord Biotech Ltd is gearing up for a strategic expansion into the United States, following a major regulatory milestone. The Ahmedabad-based biopharma firm has received an Establishment Inspection Report (EIR) from the U.S. FDA for its Dholka API facility, confirming full compliance and clearing the path for increased exports and partnerships in the American market.

 

The inspection, conducted between April 28 and May 2, 2025, concluded with no regulatory action required, a significant endorsement of Concord’s manufacturing standards. This development is expected to accelerate the company’s plans to scale its fermentation-based API operations and deepen its footprint in regulated markets like the U.S., Europe, and Japan.
 

Key Highlights:

 

- USFDA EIR received for Dholka facility, enabling unrestricted operations.

 

- Expansion aligns with Concord’s strategy to grow its fermentation-based API portfolio, especially in immunosuppressants, oncology, and anti-infectives.

 

- The company is also exploring Contract Development and Manufacturing Organization (CDMO) opportunities in the U.S.

 

- Concord aims to launch 3–5 new products over the next 3 years, with a focus on high-margin, complex APIs.

 

- The U.S. expansion is part of a broader global push, with Concord already present in 70+ countries and holding over 20% market share in key molecules.

 

With a nearly debt-free balance sheet, robust R&D pipeline, and regulatory tailwinds, Concord Biotech is poised to become a formidable player in the global biopharma supply chain.

 

Source: Business Upturn, Concord Biotech Annual Report, Capital Market News