Glenmark Generics receives approval from the USFDA for Norethindrone Acetate tablets

Date: 23 July 2010

Press Release                                                                             For Immediate Release                     

Glenmark Generics receives approval from the USFDA for Norethindrone Acetate tablets-       

This is Glemark’s second  product approval for hormones

July 22, 2010: Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics Ltd, today announced they have been granted final ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Norethindrone Acetate 5mg tablets and will commence marketing and distribution of the product immediately.    

Norethindrone Acetate is the generic version of Duramed Research, Inc.’s Aygestin® and is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. According to IMS health, Norethindrone Acetate tablets garnered approximately USD 27 million in sales for the 12 month period ending March 2010.

Today’s approval marks the second product approval by the U.S. FDA from Glenmark’s state-of-the-art hormone facility located in Goa, India. Glenmark continues to build an extensive pipeline in this arena with a specialized portfolio in various stages of development, from early R&D to pending ANDA’s with the U.S. FDA. 

Glenmark’s current portfolio consists of 57 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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