HomeGGL granted tentative approval by US-FDA for Trandolapril & Verapamil Hydrochloride tablets
Date: 22 January 2010
Glenmark Generics Ltd granted tentative approval by US-FDA for Trandolapril and Verapamil Hydrochloride extended-release tablets
· Glenmark believes that as of date it has sole first-to-file status on this product
January 22, 2010 : Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics Ltd (GGL), today announced that it has been granted tentative approval by the United States Food and Drug Administration (U.S. FDA) for trandolapril and verapamil hydrochloride extended-release tablets, its generic version of Abbott’s Tarka® tablets.
Glenmark believes that as of date it has first-to-file status on trandolapril and verapamil hydrochloride extended-release tablets, which provides Glenmark the potential of 180 days of generic marketing exclusivity. Glenmark therefore would have the first opportunity among all potential generic competitors to market a generic equivalent to Tarka®, which achieved sales of USD 64 million for the 12-month period ending September 2009(Source : IMS). Product launch is dependent upon receipt of final approval of Glenmark's ANDA from the U.S. FDA and resolution of litigation currently pending in the US District Court for the District of New Jersey.
In a statement from Glenmark Generics Ltd’s Chief Executive Officer, Mr. Terrance Coughlin commented, “Today’s announcement is an important step in the evolution of Glenmark in the United States. In 2010 fiscal year to date, we have received 6 tentative approvals and 6 final approvals from the FDA. Today’s tentative approval is the third granted to Glenmark within a one month time frame. We will continue to rely on the strength of our portfolio and the expertise of our scientists in India to sustain a significant place in this market.”
Glenmark’s current marketing portfolio consists of 49 products authorized for distribution in the United States and it has nearly 50 ANDAs in various stages of the approval process with the U.S. FDA. The Company remains focused on strategic planning and development and continues its aggressive filing schedule for new ANDA submissions.
About Glenmark Generics Ltd.
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, EU 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 65 countries, including the US, various countries in the EU, South America and India.
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has eight molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.], Metabolic Disorders [diabetes, obesity, etc.] and Pain [neuropathic pain and inflammatory pain]. The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres.
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.
” ###
Download PDF
