Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for potassium chloride extended-release tablets USP, 10 mEq (750 mg) and 20 mEq (1500 mg), the generic version of K-Dur (potassium chloride) extended-release tablets, 10 and 20 mEq, of Merck Sharp and Dohme Corp (which is no longer being marketed in the United States).

According to IMS Health sales data for the 12 month period ending May 2016, the K-Dur (potassium chloride) extended-release tablets, 10 and 20 mEq market achieved annual sales of approximately $283.2 million.

Glenmark’s current portfolio consists of 117 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.