biospectrumasiaJuly 09, 2019
Tag: Glenmark , ANDA , 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.
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