Lupin Receives US Food and Drug Administration Approval For Simvastatin Pills
Lupin Pharmaceuticals, Inc. announced today that it has received final acceptance from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Simvastatin Pills 10mg, 20mg, 40mg and 80mg.
Lupin’s Simvastatin Pills are the AB-rated generic equivalent of Merck’s Zocor(R) pills. Simvastatin is indicated for the medical care of high cholesterol.
Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. commented, “We are delighted to receive final Food and Drug Administration acceptance for Simvastatin Pills. The addition of generic Zocor(R) complements Lupin’s commitment to bringing high-quality, low cost medicate alternatives to the American public.”
With this acceptance , Lupin now has 21 ANDAs approved by the US Food and Drug Administration.
About Lupin
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with strong research focus. It has a program for developing New Chemical Entities. The Company has state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular medicate s (prils and statins) and has a notable presence in the areas of diabetology, NSAIDS and Asthma.
For the financial year ended March 2007, Lupin’s Revenues and Profit after Tax were Rs.20, 289 mil. (US$ 475 mil.) and Rs. 3,021 mil. (US$ 70 mil.) respectively.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsiwriting of Lupin Limited, which is among the top five Pharmaceutical companies in India. 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 otherness factors that may cause actual results to be materially difference from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and otherness factors include failure of clinical trials, delays in development, registration and product acceptance s, 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 otherness 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
Zocor(R) is a registered trademark of MERCK & CO., Inc.
Lupin Pharmaceuticals, Inc.
http://www.lupinpharmaceuticals.com