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Glenmark Pharmaceuticals’ arm receives ANDA approval for Solifenacin Succinate Tablets

Glenmark Pharmaceuticals’ subsidiary — Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from United States Food & Drug Administration (USFDA) for Solifenacin Succinate Tablets, 5 mg and 10 mg, a generic version of Vesicare Tablets, 5 mg and 10 mg1, of Astellas Pharma US, Inc. According to IQVIA sales data for the 12 month period ending March 2019, the Vesicare Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately $942.7 million.

Glenmark’s current portfolio consists of 154 products authorized for distribution in the US marketplace and 58 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).

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