BALTIMORE, Aug. 31, 2011 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) today announced that it has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its Tramadol ER shortly.
Tramadol HCl ER is a centrally acting synthetic analgesic in an extended release formulation. It is the generic equivalent to Ortho-McNeil's Ultram®* ER Tablets and is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Tramadol HCl ER tablets had annual sales of approximately $132 million for the twelve months ended June 2011 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. The Company today has significant market share in Cardiovasculars, Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs in addition holding global leadership positions in the Anti-TB and Cephalosporins space.
Today, Lupin is the 5th largest and fastest growing generics player in the US (by prescriptions), the only Asian company to achieve that distinction. The company is also the fastest growing top 10 pharmaceutical player in India, Japan and South Africa. (IMS Health)
For the financial year ended March 2011, Lupin's Consolidated Revenues and Profit after Tax were Rs.57,068 million USD 1.28 Billion) and Rs. 8,626 million (USD 193 million) respectively. Please visit http://www.lupinworld.com for more information about Lupin Ltd.
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