Glenmark Pharma gets USFDA approval for Zyvox tablets
Mumbai-based Glenmark Pharmaceuticals Ltd. on Tuesday announced that it has received United States Food & Drug Administration (USFDA) approval for a generic version of anti-bacterial drug Zyvox. The drug Linezolid tablets, 600 mg is the therapeutic equivalent of anti-bacterial Zyvox tablets, 600 mg of Pharmacia and Upjohn Company - a subsidiary of Pfizer Inc. “According to IMS health sales data for the 12 month period ending October 2015, the Zyvox tablets, 600 mg achieved annual sales of approximately $447.6 million,” Glenmark Pharma Ltd. said in a statement. Glenmark currently has 104 products authorised for distribution in the U.S. marketplace and 62 ANDA’s pending approval with the USFDA. The drug-major continues to identify and explore external development partnerships to supplement and accelerate growth in its existing portfolio. Glenmark Pharmaceuticals Ltd. (GPL) is currently ranked among the world’s top 80 pharma & biotech companies, which along with its subsidiary, has 16 manufacturing facilities and six R&D centers in four countries. Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity), with its several molecules in various stages of clinical development in the areas of inflammation and pain.
December 22, 2015 | 02:00pm IST