Glenmark Generics receives approval from the USFDA for Adapalene Gel

Date: 02 July 2010

Press Release                                                                             For Immediate Release                      

Glenmark Generics receives approval from the USFDA for Adapalene Gel

July 2, 2010: Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics Limited (GGL), has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Adapalene Gel, 0.1% and will soon commence marketing and distribution of this product in the U.S. market. The Company anticipates a successful launch based on their semi-solid experience and the limited number of competitors in this market.Adapalene Gel is indicated for the topical treatment of acne vulgaris. Glenmark’s product is the AB rated generic equivalent of Galderma’s Differin® gel which generated approximately USD 84 million in sales for the 12 month period ending March 2010, according to IMS Health. Today’s approval expands the volume of the Company’s portfolio to include a total of 15 semi-solid products authorized for distribution.  

Glenmark’s current portfolio consists of 55 products authorized for distribution in the U.S. marketplace.  The Company has over 50 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

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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