Glenmark Generics receives approval from USFDA for Moexipril Hydrochloride Tablets
March 18, 2010 : Glenmark Generics Inc., USA , the subsidiary of Glenmark Generics Ltd, today announced that the USFDA has granted final ANDA approval for Moexipril Hydrochloride (HCl) and Hydrochlorothiazide tablets - the generic version of Schwarz Pharmaceuticals’ Uniretic®. The product is currently available and will begin shipping immediately. Moexipril Hydrochloride belongs to a class of drugs considered as ACE inhibitors. Glenmark’s combination product of Moexipril Hydrochloride plus the diuretic hydrochlorothiazide is indicated for treatment of patients with hypertension. Total sales for this combination during 12 month period ending December 2009 were USD 8 million, according to IMS Health. Today’s approval comes shortly after Glenmark’s announcement of final ANDA approval for Ropinirole Hydrochloride tablets, the generic version of GSK’s Requip® tablets. Glenmark has just launched Ropinirole Hydrochloride tablets in the US market. According to IMS Health, total sales were in excess of USD 104 million for the 12 month period ending December 2009. Glenmark is currently authorized to distribute 51 products in the United States. The Company currently has nearly 98 ANDAs filed or marketed in the U.S. and continues to rely on the strength of its internal pipeline projects as well as continuing to explore partnerships to augment the breadth of their existing portfolio.
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.” For further information, please contact:
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