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

March 3, 2011

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 : connect@glenmark-generics.com

SOURCE Glenmark Pharmaceuticals Ltd.


Source: newswire



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