Glenmark Generics receives approval from USFDA for Moexipril Hydrochloride Tablets

Date: 01 April 2010

Press Release                                                                                          For Immediate Release                      

Glenmark Generics receives approval from USFDA for Moexipril Hydrochloride Tablets

In March, Glenmark also received ANDA approval on the combination product Moexipril Hydrochloride and Hydrochlorothiazide tablets  

 

April 1, 2010 : Glenmark Generics Limited (GGL) today announced that their United States subsidiary, Glenmark Generics Inc., USA (GGI), has received final ANDA approval for Moexipril Hydrocholoride 7.5mg and 15 mg tablets from the U.S. Food and Drug Administration (FDA) and will commence marketing and distribution of the product immediately. 

Moexipril HCl is the generic equivalent of Univasc® tablets, marketed by Schwarz. The product is indicated for the treatment of patients with hypertension and garnered total sales of over USD 9 million for the 12 month period ending December 2009, according to IMS Health. 

In March, Glenmark also received ANDA approval on Moexipril Hydrochloride and Hydrochlorothiazide tablets which was the generic version of Schwarz Pharmaceuticals’ Uniretic®. 

When approached about today’s news, Mr. Terrance Coughlin, CEO of Glenmark Generics Limited stated, “Today’s approval signifies Glenmark’s fourth ANDA approval in the final quarter of the fiscal year. We are happy to see our diligence in R&D, the tenacity of our pipeline and filing schedule realized giving us the opportunity to continue to bring quality affordable generic products to our customers.” 

 

Within the previous six weeks, Glenmark has received final ANDA approvals for Ropinirole HCl tablets, Moexipril HCl & Hydrochlorothiazide tablets and Calcipotriene Ointment 0.005%.

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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