Letitia Robinson, Director, US FDA, India Office
Dr. Letitia Robinson, Director of the US FDA India Office, provides insights into the main goals and responsibilities of the FDA in India and documents the US FDA’s collaboration efforts…
Address: Lupin LtdB/4 Laxmi TowersBandra Kurla ComplexBandra (E)Mumbai 400 051India
Tel: +91 22 6640 2222
Web: http://www.lupinpharmaceuticals.com/
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.
We are building on our 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 committed to achieving 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. Please visit http://www.lupinworld.com for more information about Lupin Limited.
– Generics:
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.
-Specialty:
Lupin Pharmaceuticals, Inc., is very pleased to offer Suprax®, an important anti-infective product in pediatric and other physician practices within the United States. Suprax® is now available in tablets and suspension formulations. Lupin Pharmaceuticals, Inc., has an exclusive license in the United States to use the Suprax® trademark.
-API:
Lupin is recognized as a leading manufacturer of cephalosporin API’s, with FDA approval to manufacture complex oral and injectable cephalosporins.
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