Glenmark gets USFDA nod for generic Prograf Capsules

Mumbai: Glenmark Pharmaceuticals Inc., USA today announced that the company has been granted final approval by the United States Food & Drug Administration (USFDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg.

The product is a generic version of Prograf Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc.

According to IQVIA sales data for the 12 month period ending September 2020, the Prograf Capsules, 0.5 mg, 1 mg and 5 mg market achieved annual sales of approximately $286.8 million*.

Glenmark's current portfolio consists of 166 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the U.S. FDA.

In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.