Lupin in alliance with Concord receives USFDA approval for Mycophenolate Mofetil

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An Indian multinational pharmaceutical company headquartered in Mumbai, Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord) recently announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolate Mofetil Tablets USP, 500 mg, to market a generic version of CellCept® Tablets of Roche Palo Alto LLC (Roche).

Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

Mycophenolate Mofetil Tablets USP, 500 mg (RLD: CellCept®) had an annual sale of approximately USD 96 million in the U.S. (IQVIA MAT Mar 2020).