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Lupin gets US approval for schizophrenia drug

New York, March 5 (): Lupin Ltdhas received the U.S. Food and Drug Administration’s approval for the generic version of Geodon capsules used to treat schizophrenia, the drugmaker said on Monday.

The Geodon brand, owned by Pfizer Inc, had annual sales of $1.35 billion in the United States in 2011, Lupin said in a statement.

Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top five pharmaceutical companies in India. Through our sales and marketing headquarters in Baltimore, MD, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, branded and generic medications trusted by healthcare professionals and patients across geographies.

Lupin Limited, headquartered in Mumbai, India, is strongly research focused. It has a program for developing New Chemical Entities. The company has a state-of-the-art R&D center in Pune and is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (ACE-inhibitors and cholesterol reducing agents) and has a notable presence in the areas of diabetes, anti-inflammatory and respiratory therapy.

Building on the  parent company’s strengths of vertical integration in discovery research, process chemistry, active pharmaceutical ingredient production, formulation development and regulatory filings, Lupin Pharmaceuticals, Inc. is moving towards its vision and mission of becoming an innovation led transnational pharmaceutical company.

Vinita Gupta, CEO of Lupin Pharmaceuticals, Inc. says “founded on the strengths of our parent company Lupin Limited, Lupin Pharmaceuticals, Inc. intends to bring a portfolio of generics as well as branded products to the US market.”For the financial year ended March 2010, Lupin Limited’s Revenues and Profit after Tax were Rs.47,678 million (US$ 1.1 billion) and Rs.6,186 million (US$ 152 million) respectively.

Lupin Pharmaceuticals, Inc. entered the U.S. generic pharmaceutical market in 2003 with the ANDA approval for cefuroxime axetil. Since then we have received more than a dozen FDA approvals. Six of Lupin’s 14 ANDA approvals were the first granted by the US FDA.