Glenmark Generics Ltd's US subsidiary (GGI) has received ANDA approval from the United States Food and Drug Administration (US FDA) for Ranitidine 150 mg and 300 mg tablets and will soon commence marketing and distribution of these products in the US 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 US 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 US 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.