Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Rifabutin Capsules USP, 150 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Pharmacia and Upjohn Company's Mycobutin® Capsules 150 mg. Lupin Pharmaceuticals Inc. (LPI), the company's US subsidiary would commence marketing the product shortly.
Lupin's Rifabutin Capsules, 150 mg are generic equivalent of Pharmacia And Upjohn Company's Mycobutin® Capsules 150 mg. Lupin's Rifabutin Capsules USP, 150 mg is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
Mycobutin® Capsules had annual U.S sales of US$ 18.6 million (IMS MAT Dec, 2013).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations 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 the 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 revenues. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).
For the financial year ended March 2013, Lupin's Consolidated turnover and Profit after Tax were Rs. 94,616 million (USD 1.74 billion) and Rs. 13,142 million (USD 242 million) respectively. Please visit http://www.lupinworld.com for more information.
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, visit http://www.lupinpharmaceuticals.com.