Glenmark receives ANDA approval for Ranolazine Extended-Release Tablets

Glenmark Pharmaceuticals Inc. has been granted final approval by the United States Food & Drug Administration for Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg, a generic version of Ranexa® Extended-Release Tablets, 500 mg and 1,000 mg, of Gilead Sciences, Inc.

According to IQVIATM sales data for the 12 month period ending May 2019, the Ranexa® Extended-Release Tablets, 500 mg and 1,000 mg market2 achieved annual sales of approximately $929.0 million.

Glenmark’s current portfolio consists of 158 products authorized for distribution in the U.S. marketplace and 57 ANDA’s pending approval with the USFDA.