Glenmark Pharmaceuticals gets USFDA’s final nod for Tacrolimus Ointment, 0.03%

17 Aug 2023 Evaluate

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (USFDA) Tacrolimus Ointment, 0.03%, the generic version of Protopic 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% market achieved annual sales of around $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.  

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.


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