HomeGlenmark to launch Fosinopril Sodium and Hydrochlorothiazide tablets in the US
Date: 10 July 2009
- ANDA approval was through Glenmark's partnership with Invagen Pharmaceuticals Inc, USA
- Tablets are indicated for the treatment of hypertension
July 10, 2009: Glenmark Generics Inc., USA (GGI), the US subsidiary of Glenmark Generics Limited and a leading company in the manufacture, marketing and distribution of high-quality, low-cost generic pharmaceutical products in the US, initiated the launch of Fosinopril Sodium and Hydrochlorothiazide tablets in the U.S. market.
Fosinopril Sodium and Hydrochlorothiazide(HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths and are indicated for the treatment of hypertension. Glenmark’s product is the AB rated therapeutic equivalent of Bristol Myers Squibb’s Monopril-HCT®. Overall generic market sales for the product is approximately USD 10 million for the 12 month period ending March 2009, according to IMS Health Data.
Terrance Coughlin, Chief Executive Officer, Glenmark Generics Limited commented, “Glenmark is prepared to commence shipping based on today’s final approval from the U.S. FDA. As Fosinopril + HCTZ is a maintenance medication, we are very pleased with this approval as it gives us the chance to provide customers with guaranteed and uninterrupted supply which they may not have been getting in the past. We anticipate a successful launch considering the limited competitive landscape coupled with the niche positioning of this product.”
The Abbreviated New Drug Application (ANDA) for Fosinopril Sodium and Hydrochlorothiazide tablets was approved through Glenmark’s longstanding partnership with InvaGen Pharmaceuticals Inc. (InvaGen). The Company will exclusively market and distribute the product while InvaGen will be responsible for their manufacture and supply. All development, regulatory costs and profits on Fosinopril Sodium and Hydrochlorothiazide tablets’ sale in the U.S. will be shared equally between Glenmark and Invagen.
In fiscal year 2006, Glenmark and InvaGen entered into a collaboration agreement for the joint development, filing and marketing of several generic pharmaceutical products for the U.S. market. The product list included a mixture of off-patent and patent-protected molecules.
This recent approval expands Glenmark’s portfolio to 46 generic products authorized for distribution in the US market. The Company has over 40 ANDAs pending approval with the U.S. FDA.
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. GGL has a strong base in Formulations development with teams operating out of laboratories in India and Latin America. The Company has a state-of-the-art manufacturing plant at Goa, India that is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities. GGL also markets over 45 APIs to more than 80 countries across the world and has over 30 USDMFs approved along with several Canadian DMFs, EDMFs and CEPs/CoSs. [www.glenmark-generics.com]
About Glenmark Pharmaceuticals Ltd. Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. The company is listed on India’s two premier stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5500 people across its global operations over 85 countries. The Company is a leader in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.], and metabolic disorders [Diabetes, Obesity, etc.]. The company has a significant presence in branded generics markets across emerging economies including India.
In December 2008, Glenmark bagged the prestigious SCRIP award for the “Best Pharma Company in the World – SME” and the “Best Company in Emerging Markets” at the SCRIP Awards 2008 in London. For more information on GPL, log on to http://www.glenmarkpharma.com/
For further information, please contact:
Jason D’Souza | Medha Satam
Glenmark, Mumbai, India
Tel: [+91 22] 40189919 / 40189993
Email : connect@glenmark-generics.com
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