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Glenmark receives ANDA approval for generic version of Rythmol SR Capsules

11 Sep 2017 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg, the generic version of Rythmol SR Capsules, 225 mg, 325 mg, and 425 mg, of GlaxoSmithKline, LLC.

According to IMS Health sales data for the 12 month period ending July 2017, the Rythmol SR Capsules, 225 mg, 325 mg, and 425 mg market achieved annual sales of approximately $69.2 million.

Glenmark’s current portfolio consists of 123 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.


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