Glenmark Pharmaceuticals Receives ANDA Approval for Colesevelam Hydrochloride Tablets, 625 mg

Tuesday, May 22, 2018 Drug News
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MUMBAI, May 22, 2018 /PRNewswire/ --

Glenmark Pharmaceuticals Inc., USA (Glenmark)

has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Colesevelam Hydrochloride Tablets, 625 mg, the generic version of Welchol®1 Tablets, 625 mg, of Daiichi Sankyo Inc. The company has already
commenced supplies of the product to the US market.

     (Logo: http://mma.prnewswire.com/media/451507/PRNE_Glenmark_Logo.jpg ) According to IQVIA sales data for the 12 month period ending March 2018, the Welchol® Tablets, 625 mg market2 achieved annual sales of approximately $519.9 million*.

Glenmark's current portfolio consists of 135 products authorized for distribution in the U.S. marketplace and 62 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.  

About Glenmark Pharmaceuticals Ltd.:   

Glenmark Pharmaceuticals Ltd. (GPL) is a research?driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2017). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of oncology, dermatology and respiratory.

The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark along with its subsidiary has 17 manufacturing facilities across five countries and has six R&D centers. 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.

1All brand names and trademarks are the property of their respective owners.

2Market includes brand and all available therapeutic equivalents

*IQVIA National Sales Perspectives: Retail & Non-Retail, March 2018

Media Contact: 

Ramkumar Uppara ramkumar.uppara@glenmarkpharma.com +91-9820177907 Senior Manager Glenmark Pharmaceutials

Isha Trivedi isha.tridevi@glenmarkpharma.com Deputy General Manager Glenmark Pharmaceutials



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