Lupin’s Alliance Partner Concord Receives U.S. FDA Approval for Tacrolimus Capsules USP

Mumbai, November 12, 2020: Pharma major Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord) announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, to market a generic version of Prograf® Capsules, 0.5 mg, 1 mg, and 5 mg, of Astellas Pharma US, Inc.

Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immuno suppressants.

Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg (RLD: Prograf®) had an annual sales of approximately USD 303 million in the U.S. (IQVIA MAT September 2020).

Corporate Comm India (CCI Newswire)