Ahmedabad, India | June 2, 2026 Concord Biotech Limited, a leading research-driven biopharmaceutical company specializing in fermentation-based Active Pharmaceutical redients (APIs) and formulations, today announced that it has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL.

Advancing our U.S. footprint through Stellon Biotech

The product will be marketed in the United States through its U.S. subsidiary, Stellon Biotech Inc. The product is a generic equivalent of CellCept® Oral Suspension, 200 mg/mL, of Genentech, Inc.

About Mycophenolate Mofetil for Oral Suspension USP

Mycophenolate Mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients aged three months and older who have received allogeneic kidney, heart, or liver transplants. The medication is administered in combination with other immunosuppressive agents as part of a comprehensive transplant management regimen.

Growth Opportunity in the U.S. Transplant Therapeutics Market

The ANDA approval marks another significant milestone in Concord Biotech’s strategy to expand its formulations business and strengthen its nce in the United States pharmaceutical market. According to market estimates, the U.S. market for Mycophenolate Mofetil is valued at approximately USD 30 million.

Strengthening Concord Biotech’s Global Product Portfolio

This approval reflects Concord Biotech’s ongoing commitment to expanding access to high-quality, affordable therapies for patients across critical care settings globally. Stellon remains focused on building a meaningful presence in the U.S. market through a differentiated portfolio and continued investment in our development pipeline.