Glenmark receives final ANDA approval

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


Clenmark Generics Inc., USA the subsidiary of Glenmark Generics Ltd has  been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Acamprostrate Calcium Delayed Release Tablets its generic version of forest Laboratories' Campral Delayed release Tablets. Acamprostrate is indicated for the maintenance of abstinence from alcohol dependence.

Based on IMS Health sales data for the last 12 month period ending on march 2013, Acamprosate garnered sales of USD 21 million. In addition to these internal filings, GGI continues to identify and explore external development partnership to supplement and accelerate the growth of the existing pipeline and portfolio.

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