Glenmark Generics Receives Final Approval From the U.S. FDA for Levocetirizine Dihydrochloride

Mar 03, 2011, 06:06 ET from Glenmark Pharmaceuticals Ltd.

MUMBAI, India, March 3, 2011 /PRNewswire-FirstCall/ --

- This Press Release Supersedes and Replaces the Prior Release.

Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Levocetirizine Dihydrochloride 5 mg tablets, the generic version of UCB Inc.'s Xyzal(R) tablets.

Glenmark's levocetirizine dihydrochloride tablets are currently available and shipping will commence immediately from the Company's New Jersey facility. Total U.S. sales as reported by IMS Health for the 12 month period ending December 2010 were approximately USD 231 million.

The Company's current portfolio consists of 69 generic products authorized for distribution in the U.S. market and approximately 40 ANDA's filed with the U.S. FDA pending approval. 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.

About Glenmark Generics Limited.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the United States ("US") and the European Union ("EU"), as well as its oncology FDF products in South America. The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.

    For further information, please contact:

    Jason D'Souza
    Glenmark, Mumbai, India Tel: +91-22-40189919
    Email :

SOURCE Glenmark Pharmaceuticals Ltd.