Concord Biotech has received approval from the U.S. Food and Drug Administration (USFDA) for its ANDA for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
According to market estimates, the U.S. market for Mycophenolate Mofetil is around $30 million. The approval positions the company to capitalize on these attractive market opportunities, enhance its product offerings, and support its long-term growth strategy across the U.S. and international markets.
Concord Biotech is an India-based biopharma company and one of the leading global developers and manufacturers of select fermentation-based APIs across Immunosuppressants and oncology.
