HomeGlenmark Europe receives UK-MA approval for Ropinirole Tablets & to distribute Lercanidipine HCL tab
Date: 07 April 2010
Press Release For Immediate Release
Glenmark Generics receives UK-MA approval for Ropinirole film-coated tablets and to distribute Lercanidipine Hydrochloride film-coated tablets
- Both products launched in the UK in Glenmark livery
April 7, 2010 : Glenmark Generics (Europe) Limited(GGEL), the European subsidiary of Glenmark Generics Limited received regulatory approval from the UK Medicines and Healthcare products Regulatory Authority (MHRA) for Ropinirole film-coated tablets. GGEL has commenced the marketing and distribution of this product in the UK market for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in the following packs: 0.25 mg 12’s; 0.5 mg 28’s, 1 mg 84’s and 2 mg 84’s.
Ropinirole is a non-ergoline D2/D3 dopamine agonist which stimulates striatal dopamine receptors. Moderate to severe idiopathic Restless Legs Syndrome is typically represented by patients who suffer with insomnia or severe discomfort in the limbs. Glenmark Generics (Europe) Limited’s Ropinirole 0.25 mg, 0.5 mg, 1 mg and 2mg Tablets are the generic equivalent of Requip®. The IMS number (2008) for sales of Ropinirole in the UK was Euro 24 million for this indication
Glenmark Generics (Europe) Limited also began distributing Lercanidipine Hydrochloride film-coated tablets. Lercanidipine is a selective calcium channel blocker of the dihydropyridine group with mainly vascular effects, lowering total peripheral resistance. It is indicated for the treatment of mild to moderate essential hypertension. Glenmark Generics (Europe) Limited’s Lercanidipine 10 mg and 20 mg tablets are the generic equivalent of Zanidip®. The IMS number (2008) for sales of Lercanidipine in the UK was Euro 9.8 million.
With this latest approval and other internal filings Glenmark Generics (Europe) Limited continues to broaden its UK portfolio and in parallel continues to identify and engage in external partnerships to supplement and accelerate the growth of its European business.
About Glenmark Generics (Europe) Ltd.:
Glenmark Generics (Europe) Limited (GGEL) is a wholly owned subsidiary of Glenmark Generics Ltd. GGEL is engaged in marketing, licensing and distribution of generic products throughout Europe.
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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