Glenmark Generics (GGL), a US subsidiary of Glenmark Phamaceutical, has received ANDA approval from the US FDA for Verapamil 240mg extended release tablets and will immediately commence marketing and distribution in the US market.
Verapamil SR tablets are indicated for the management of essential hypertension and are the generic equivalent of Isoptin SR tablets. The 240 mg strength has more than half the market share of the overall Verapamil SR product line. Total sales for the twelve month period ending June 2009 was USD 65 million, as per IMS Health.
Terrance Coughlin, chief executive officer, Glenmark Generics commented, "This approval and launch holds significance for Glenmark Generics as it marks our entry into the extended release segment which is a differentiated and niche segment. This segment has tremendous potential in the US generics market and over the past few years, we have invested resources to build expertise in this specialized area. Besides this approval, we have also filed a number of ANDAs in the Extended Release segment that are pending for approval with the US FDA"
Today's approval expands Glenmark's current portfolio to a total of 49 generic products authorized for distribution in the US market. The company currently has over 45 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.