Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced today that it has received final approval for its Fenofibrate Tablets 54 mg and 160 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Teva’s Fenofibrate Tablets, 54 mg and 160 mg. Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US.
Lupin’s Fenofibrate Tablets 54 mg and 160 mg is the AB rated generic equivalent of the current reference listed drug, Fenofibrate Tablets 54 mg and 160 mg of Teva. It is indicated as an adjunct to diet to reduce elevated LDLC, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and for treatment of adult patients with severe hypertriglyceridemia.
Fenofibrate Tablets 54 mg and 160 mg has US sales of USD 156 million (IMS MAT June 2015)
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations as well as biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.
Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also amongst the top 10 generic pharmaceutical players in Japan and South Africa (IMS). For the financial year ended 31st March 2015, Lupin’s Consolidated turnover and Profit after Tax were 125,997 million (USD 2.06 billion) and 24,032 million (USD 393 million) respectively. Please visit http://www.lupin.com for more information.
About Aenova Group
The Aenova Group is one of the world’s largest providers of services covering the entire value chain for the development and production of all the main dosage forms and product groups in the field of medicines and dietary supplements. As the European business-to-business market leader, the Aenova Group focuses on high standards of quality, innovative technologies and a clear vision for the future. The group operates overall 29 locations in eleven countries and employs more than 4700 people.
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CIN: L24100MH1983PLC029442 Registered Office: 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai – 400 098.
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