Glenmark Generics’ Verapamil SR tablets receives ANDA approval
Glenmark Generics Limited received ANDA approval for Verapamil 240mg which is indicated for management of essential. Verapamil SR tablets are the generic equivalent of Isoptin SR tablets. Verapamil 240mg has strength of more than half the market share of the overall Verapamil SR product line. The total sale for the twelve month period ending June 2009 was USD 65 million, according to IMS Health.
Verapamil is used to treat hypertension (high blood pressure), angina (chest pain). This is used for some certain heart rhythm disorders. Verapamil’s mechanism in all cases is to block voltage-dependent calcium channels. It works by relaxing the muscles of your heart and blood vessels.
Calcium channels are also present in the smooth muscle that lines blood vessels. By relaxing the tone of this smooth muscle, calcium-channel blockers dilate the blood vessels. This has led to their use in treating hypertension and angina pectoris
Terrance Coughlin, CEO, Glenmark Generics Ltd said “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”
The ANDA approval expands Glenmark’s current portfolio to a total of 49 generic products authorised 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.
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