BALTIMORE, Feb. 8 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Commercial shipments of the product have already commenced.
Commenting on the approval, Vinita Gupta, President and CEO of Lupin Pharmaceuticals, Inc., said, “We are very pleased with the approval of our Amlodipine/Benazepril capsules. This is a significant approval and it broadens our growing portfolio of cardiovascular medications with a strong complement to our existing product line.” Ms. Gupta added, “The approval reflects the confidence and acceptance of our facility by the FDA, as well as our unwavering commitment to quality and to bringing important products to market.”
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company today has significant market share in key markets in the Cardiovasculars (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, not to mention global leadership positions in the Anti-TB and Cephalosporins. The Company’s R&D endeavors have resulted in significant progress in its NCE program. The Company’s foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.
For the financial year ended March 2009, Lupin’s Consolidated Revenues and Profit after Tax were Rs.39,145 million (US$851 million) and Rs. 5015 million (US$109 million) respectively. Please visit http://www.lupinworld.com for more information about Lupin Ltd.
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Lupin Pharmaceuticals, Inc.
