Concord Biotech Limited has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL. Concord Biotech disclosed the regulatory milestone to the National Stock Exchange of India and BSE Limited on June 2, 2026.
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult and pediatric recipients aged 3 months and older of allogeneic kidney, heart or liver transplants. The drug is used in combination with other immunosuppressants including calcineurin inhibitors and corticosteroids as part of post-transplant immunosuppressive therapy for organ transplant recipients.
The US market for Mycophenolate Mofetil is estimated at approximately US$ 30 million based on market estimates. The USFDA approval enables Concord Biotech to offer the oral suspension formulation at 200 mg/mL strength in the US market. This approval adds a new product to Concord Biotech's offerings for the US generic pharmaceuticals segment.
The ANDA approval allows Concord Biotech to expand its presence in regulated international pharmaceutical markets. Concord Biotech can now market Mycophenolate Mofetil for Oral Suspension USP across the United States. The oral suspension formulation provides a liquid alternative dosage form of the immunosuppressant. This approval expands Concord Biotech's product pipeline for the US generics market.
The approval was disclosed under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.