Glenmark Generics receives USFDA approval for Norethindrone tablets

Date: 26 April 2010

 

 

Press Release                                                                                For Immediate Release      

Glenmark Generics receives USFDA approval for Norethindrone tablets

• This is the first approval for an Indian company in the USD 4.5 billion dollar oral contraceptive segment
• The product will be marketed under the brand name Heather®

Mumbai April 26, 2010 : Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, today announced they have been granted approval by the United States Food and Drug Administration (U.S. FDA) for Norethindrone tablets 0.35mg, their generic version of Nor-QD®. The product will be marketed under the trade name Heather®) and distribution is expected to start immediately. 

Glenmark is currently the only Indian company to be granted an ANDA approval on an oral contraceptive product. The US contraceptive market has historically been the largest of the seven major markets with sales reaching USD 4.5 billion in the 12 month period ending December 2009 (MIDAS sales data, IMS Health) 

Commenting on this development, Mr. Terrance Coughlin, CEO, Glenmark Generics Limited said "This is a milestone in the evolving history of Glenmark Generics. Heather represents our first launch of an oral contraceptive in the United States and the first FDA approval on a product out of our hormone facility located in Goa, India" 

Norethindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy. Total sales of this niche generic contraceptive product were USD 38 million for the 12 month period ending December 2009, according to IMS Health. 

Glenmark already has existing abbreviated new drug applications (ANDAs) pending approval  with the U.S. FDA along with additional products in various stages of development within this oral contraceptive therapeutic segment.

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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