Glenmark Generics receives approval from USFDA for Trospium tablets

Date: 16 August 2010

 Press Release                                                                             For Immediate Release    

Glenmark Generics receives approval from USFDA for Trospium tablets 

August 16, 2010: Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics Limited, today announced they have received final approval from the United States Food and Drug administration (U.S. FDA) for Trospium tablets 20 mg, the generic version of Sanctura® tablets by Allergan Inc. and has already commenced marketing and distribution of this product in the United States. Trospium tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. As stated by IMS Health, Sanctura® tablets achieved annual sales of USD 25 million for the 12 month period ending June 2010. 

Today's approval is Glenmark's eighth final and second tentative approval within the second quarter of their financial year. The Company is currently authorized to distribute 61 products in the United States and has 45 products pending approval with the U.S. FDA.  

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.  

Disclaimer“Glenmark Generics Limited (“Company”) is proposing, subject to market conditions and other considerations, a public issue of its equity shares and has filed a Draft Red Herring Prospectus with SEBI. The Draft Red Herring Prospectus is available on the website of SEBI at www.sebi.gov.in and the respective websites of the BRLMs at www.enam.com and www.kmcc.co.in.   Investors should note that investment in equity shares involves a high degree of risk and for details relating to the same, see the section titled “Risk Factors” of the aforementioned Draft Red Herring Prospectus.” 

This press release is not an offer of securities for sale in the United States or elsewhere.  The shares of Glenmark Generics Limited are not being registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States unless registered under the Securities Act or pursuant to an exemption from such registration.  There will be no public offering of the shares in the United States. 

NOT FOR PUBLICATION OR DISTRIBUTION IN THE UNITED STATES, CANADA, JAPAN OR AUSTRALIA

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