Glenmark gets ANDA approval for Tacrolimus Ointment, 0.03%

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) 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 US by Glenmark Pharmaceuticals, US. According to IQVIA sales data for the 12-month period ending June 2023, the Protopic Ointment, 0.03% market achieved annual sales of approximately $15.4 million*.

Glenmark’s current portfolio consists of 184 products authorised for distribution in the US marketplace and 51 ANDAs pending approval with the US FDA.