Glenmark Pharmaceuticals Limited, 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 per cent, the generic version of Protopic Ointment, 0.03 per cent, of Leo Pharma AS, the company announced through an exchange filing. Glenmark’s Tacrolimus Ointment, 0.03 per cent, 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 per cent market, 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.
Glenmark Pharmaceuticals shares
The shares of Glenmark Pharmaceuticals on Thursday morning at 10:28 am were trading at Rs 783.85, down by 1.71 per cent.
