HomeGlenmark Generics receives approval from the USFDA for Theophylline extended-release tablets
Date: 14 July 2010
Press Release For Immediate Release
Glenmark Generics receives approval from the USFDA for Theophylline extended-release tablets
July 14, 2010: Glenmark Generics Inc. (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), today announced they have been granted ANDA approval from the United States Food and Drug Administration(USFDA) for Theophylline extended-release tablets, the generic version of Purdue Pharmaceutical Products, LP Uniphyl®. Glenmark’s extended-release tablets are available in strengths of 400 mg and 600 mg. The company will commence marketing and distribution of this product immediately in the U.S and anticipates a successful launch based on limited competition existing in this niche segment. According to IMS health, Theophylline extended-release tablets had annual sales of USD 8 million. Theophylline extended release tablets are indicated for the treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g. emphysema and chronic bronchitis.
After this approval, the Company’s current portfolio consists of 56 generic products authorized for distribution in the U.S. market, as well as over 50 ANDAs are filed with the U.S. FDA for 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.
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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