Glenmark Pharmaceuticals receives ANDA approval for Potassium Chloride Extended-Release Capsules

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Potassium Chloride Extended-Release Capsules USP, 10 mEq, the therapeutic equivalent to the reference listed drug product, Potassium Chloride Extended-Release Capsules USP, 10 mEq, of Actavis Laboratories FL, Inc.

According to IMS Health sales data for the 12 month period ending November 2015, the Potassium Chloride Extended-Release Capsules, 10 mEq Market1 achieved annual sales of approximately $74.1 million.

Glenmark’s current portfolio consists of 105 products authorized for distribution in the US marketplace and 63 ANDA’s pending approval with the USFDA. 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.