Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for nitroglycerin sublingual tablets USP, 0.3 mg, 0.4 mg, and 0.6 mg, the generic version of Nitrostat sublingual tablets, 0.3 mg, 0.4 mg, and 0.6 mg, of Pfizer, Inc.

According to IMS Health sales data for the 12 month period ending July 2017, the Nitrostat sublingual tablets, 0.3 mg, 0.4 mg, and 0.6 mg market1 achieved annual sales of approximately $112.7 million.

Glenmark’s current portfolio consists of 125 products authorized for distribution in the US marketplace and 61 ANDA’s pending approval with the US 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.