Glenmark Pharmaceuticals gets US FDA approval for Tacrolimus Capsules USP

Prograf® Capsules, 0.5 mg, 1 mg and 5 mg market2 achieved annual sales of approximately $286.8 million

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf®1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc.

According to IQVIATM sales data for the 12 month period ending September 2020, the Prograf® Capsules, 0.5 mg, 1 mg and 5 mg market2 achieved annual sales of approximately USD 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.

1 All brand names and trademarks are the property of their respective owners.

2 Market includes brand and all available therapeutic equivalents

* IQVIATM National Sales Perspectives: Retail & Non-Retail, September 2020

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