Lupin receives final US FDA nod for nabumetone tabs, 500 mg and 750 mg
Lupin Pharmaceuticals, Inc. (LPI) the US subsidiary of Lupin has been granted final approval for its nabumetone tablets, 500 mg and 750 mg strengths from the US Food and Drug Administration (FDA). Lupin’s nabumetone is the AB-rated generic equivalent of GlaxoSmithKline’s relafen tablets indicated for acute and chronic treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis. Annual sales for the nabumetone market in the US was $ 66.8 million for the twelve months ended September 2010, based on IMS Health sales data.
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 cardiovascular (prils and statins), diabetology, asthma, paediatrics, CNS, GI, anti-infectives and NSAIDs therapy segments, not to mention global leadership positions in the anti-TB and cephalosporins.
For the financial year 2009-10, Lupin's Consolidated Revenues and Profit after Tax were Rs. 47,678 million (US$ 1.1 billion) and Rs. 6,816 million (US$ 152 million) respectively. The company’s R&D endeavors have resulted in significant progress in its NCE programme. The company’s foray into Advanced Drug Delivery Systems (ADDS) has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.