HomeGlenmark receives approval for Ranitidine Tablets USP from the U.S. FDA
Date: 21 November 2008
Glenmark Generics Ltd’s, US subsidiary ( GGI) has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Ranitidine 150 mg and 300 mg tablets and will soon commence marketing and distribution of these products in the U.S. market. Ranitidine tablets are approved for eight separate indications including the short-term treatment and maintenance of duodenal ulcer patients, the treatment of pathological hypersecretory conditions, the short-term treatment and maintenance of gastric ulcer patients, treatment of GERD (GastroEsophageal Reflux Disease) and the treatment and maintenance of erosive esophagitis. These varied treatment options have contributed to the overall success of the product garnering sales in excess of USD 41 million for the 12 month period ended June 2008 as reported by IMS Health.
Terrance Coughlin, Chief Executive Officer, Glenmark Generics Limited commented, “This recent approval will be the third product added to the US subsidiary’s product portfolio within this month of November alone. GGI has already completed two launches earlier this month that is Morphine Sulfate Solution Oral Concentrate 20mg/ml in three presentations as well as Azathioprine Tablets 50mg.” He further added “These three launches will give a significant boost to our product portfolio and generate good sales for the subsidiary”
Glenmark’s current portfolio now consists of 37 generic products authorized for distribution in the U.S. market. Glenmark’s focus on strategic planning and development has generated a strong pipeline in varying stages of maturity. The Company currently has 40 ANDA’s filed with the U.S. FDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and 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. 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 had over 30 USDMFs filed and/or 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. Its shares are listed on India’s two large 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 India 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 is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211 has been out-licensed to Eli Lilly & company. 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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