Glenmark Generics receives approval from the USFDA for Ropinirole Hydrochloride Tablets

Date: 02 March 2010

Press Release                                                                                          For Immediate Release 

                    

Glenmark Generics receives approval from the USFDA for Ropinirole Hydrochloride Tablets

·        Ropinirole Hydrochloride Tablets estimated market size at USD 104 million*

·        Glenmark will immediately commence marketing and distribution the approved product  

 

March 2, 2010 : Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics Limited (GGL), has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Ropinirole Hydrochloride tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg , 4 mg and 5 mg and will immediately commence marketing and distribution the approved product. Ropinirole Hydrochloride tablet is the generic version of GSK’s Requip® tablet in the U.S. market.

Ropinirole hydrochloride is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease as well as the treatment of moderate to severe primary restless leg syndrome (RLS). Total sales for Ropinirole Hydrochloride tablets in the twelve month period ending December 2009 were USD 104 million*, as reported by IMS Health.

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.”  

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