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USFDA approves Glenmark Pharma anti-anginal drug Ranolazine ER Tablets

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USFDA approves Glenmark Pharma anti-anginal drug Ranolazine ER Tablets

The approved product is a generic version of Ranexa 1 Extended-Release Tablets, 500 mg and 1,000 mg, of Gilead Sciences, Inc.

MUMBAI: Glenmark Pharmaceuticals Inc., USA (Glenmark) has received the US health regulator’s final approval for anti-anginal drug Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg.

The approved product is a generic version of Ranexa 1 Extended-Release Tablets, 500 mg and 1,000 mg, of Gilead Sciences, Inc.

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The drug improves blood flow to help the heart work more efficiently.

According to IQVIA sales data for the 12 month period ending May 2019, the Ranexa® Extended-Release Tablets, 500 mg and 1,000 mg market 2 achieved annual sales of approximately $929.0 million*.

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

Read Also: Glenmark Pharma receives USFDA approval for generic version of Vytorin tablets

Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory. The company has 16 manufacturing facilities across five countries and has six R&D centres.

The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

Read Also: Glenmark Pharma Ryaltris gets Complete Response Letter from USFDA


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