Glenmark receives final ANDA approval for Acamprosate Calcium Delayed Release Tablets

Glenmark Generics Inc, USA, the United States subsidiary of Glenmark Generics, has been granted Abbreviated New Drug Approval (ANDA) from United States Food and Drug Administration (US FDA) for Acamprosate Calcium Delayed Release Tablets, the generic version of forest Laboratories’ Camparl 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 during March 2013, Acamprosate garnered sales of $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.

Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated generic and API leader.