Lupin Receives FDA Approval For Amlodipine/Benazepril Capsules
Baltimore,MD /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced recently 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.
Lupin's Amlodipine/Benazepril capsules are the AB-rated generic equivalent of Novartis' Lotrel® capsules indicated for the treatment of hypertension. Amlodipine/Benazepril had annual sales of approximately $1.1B for the twelve months ended September 2009, based on IMS Health sales data.
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.
Our Drugs and products reach over 70 countries in the world. Today, Lupin has the unique distinction of being the fastest growing top 10 Generics players in the two largest pharmaceutical markets of the world -- The U.S. (ranked 9th by prescriptions & growing at 92 %) and Japan (ranked 7th and growing at 23%). The company is also the fastest growing, top 5 pharmaceutical players in India (ORG IMS - March 2009) and the fastest growing Generic player in South Africa (ranked 6th and growing at over 30 % YoY - IMS)
For the financial year ended March 2009, Lupin's Consolidated Revenues and Profit after Tax were Rs.39,145 million (US$851M) and Rs. 5015 million (US$109M) respectively. Please visit http://www.lupinworld.com/ for more information about Lupin Ltd.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management's expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.
Lotrel® is a registered trademark of Novartis Pharmaceuticals Corp.
SOURCE Lupin Pharmaceuticals, Inc.