Glenmark receives final ANDA approval for Acamprosate Calcium Delayed Release Tablets

Specifications:

Name:

Glenmark receives final ANDA approval for Acamprosate Calcium Delayed Release Tablets

Location:

United States of America

Company:

Estimated Cost:

Source:

Glenmark receives final ANDA approval for Acamprosate Calcium Delayed Release Tablets Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Acamprosate Calcium Delayed Release Tablets its generic version of Forest Laboratories’ Campral ®Delayed Release Tablets. Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence. Based on IMS Health sales data for the 12 month period ending March 2013, Acamprosate garnered sales of USD 21 million. Glenmark’s current portfolio consists of 88 products authorized for distribution in the U.S. marketplace and 53 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio. http://us.glenmark-generics.com/news-room-details.aspx?id=OTA= Project Name Glenmark Generics Inc Location United States of America Commence 2013 Completion NA Estimated Investment NA Capacity NA Key Players Glenmark Generics Inc