Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%

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Bangalore, India and Mahwah, New Jersey, 18th August 2023 Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, integrated, global pharmaceutical company has received final approval by the United States Food & Drug Administration (U.S. FDA) Tacrolimus Ointment, 0.03%, the generic version of Protopic1 Ointment, 0.03%, of Leo Pharma AS. Glenmark’s Tacrolimus Ointment, 0.03%, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIATM sales data for the 12-month period ending June 2023, the Protopic® Ointment, 0.03% market2 achieved annual sales of approximately $15.4 million*.

Glenmark’s current portfolio consists of 184 products authorized for distribution in the U.S. marketplace and 51 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.

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