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Biopharmaceuticals Generics FDA

 News Release - September 14, 2006

Lupin Announces Approval of Ceftriaxone 10G Vials

BALTIMORE, Sept. 14 (HSMN NewsFeed) -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Ceftriaxone Injection 10 gram vials (Pharmacy bulk pack). Ceftriaxone is the generic equivalent of Rocephin® marketed by Roche.

Lupin had launched the 250 mg, 500 mg, 1 g and 2 g strengths of ceftriaxone vials upon patent expiry on July 19, 2005. The approval of the 10 g strength now completes the entire ceftriaxone product family. Commercial shipments of the 10 g will commence immediately.

The Company has agreements with Baxter Healthcare Corporation for the U.S. hospital market and with Henry Schein, Inc. for the physician offices.

This is Lupin's 15th ANDA approval by the US FDA to date.

About Lupin

Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with a strong research focus. It has a program for developing New Chemical Entities. The Company has a state-of-the-art R&D center in Pune. The Company 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 diabetology, anti-inflammatory and respiratory therapy categories.

For the financial year ended March 2006, the Company's Revenues and Profit after Tax were Rs.16,610 million (US$ 375 million) and Rs.1,827 million (US$ 41 million) respectively. Please visit for more information about Lupin Ltd.

Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top five Pharmaceutical companies in India. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management's expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.

Source: Lupin Pharmaceuticals

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