Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Vancomycin Hydrochloride Capsules, 125 mg and 250 mg from the United States Food and Drugs Administration (FDA) to market a generic version of ANI Pharmaceuticals, Inc’s Vancocin® capsules 125 mg and 250 mg strengths. Lupin Pharmaceuticals Inc. (LPI), the company’s US subsidiary would commence marketing the product shortly.
Lupin’s Vancomycin capsules 125 mg and 250 mg are the AB rated generic equivalent of ANI Pharmaceuticals Inc’s Vancocin® capsules and are indicated for the treatment of C. difficile-associated diarrhea and also for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).
Vancocin® Capsules had annual U.S sales of US$ 164.2 million (IMS MAT September, 2014).
About Lupin Limited
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 March 2014, Lupin’s Consolidated revenues and Profit after tax were Rs. 110,866 million (USD 1.83 billion) and Rs. 18,364 million (USD 304 million) respectively. Please visit http://www.lupin.com for more information.
CIN: L24100MH1983PLC029442 Registered Office: 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai – 400 098.
About Lupin Pharmaceuticals Inc.
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, please do visit http://www.lupinpharmaceuticals.com
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For more information, please contact –
Shamsher Gorawara
Head – Corporate Communications
Ph: +91-22- 98 20 338 555
Email: shamshergorawara@lupin.com
Or
Alpesh Dalal
Head – M & A and Investor Relations
Lupin Limited
Ph: +91 98 20 023 511
Email: alpeshdalal@lupin.com