Concord Biotech Receives USFDA Approval for Mycophenolate Mofetil Oral Suspension
New Delhi: Concord Biotech has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, strengthening the company's presence in the US pharmaceutical market.
The approved product, Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients aged three months and older undergoing allogeneic kidney, heart or liver transplants. The therapy is used in combination with other immunosuppressive agents.
According to the company, the US market for Mycophenolate Mofetil is estimated at approximately USD 30 million. Concord Biotech stated that the approval will enable it to capitalize on the market opportunity, expand its product portfolio and support its long-term growth strategy in the United States as well as international markets.
The company further noted that the approval aligns with its broader growth strategy and is expected to strengthen its position in the US market. The regulatory clearance was granted by the USFDA and forms part of Concord Biotech’s efforts to expand its global footprint through specialized pharmaceutical products.
Concord Biotech informed stock exchanges that the approval would contribute to enhancing its product offerings in the immunosuppressant segment.
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