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.
About Lupin
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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