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Caraco Pharmaceutical Laboratories, Ltd. To Market Generic Sinemet(R) Tablets

Posted on: Wednesday, 5 November 2008, 12:00 CST

DETROIT, Nov. 5 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched Carbidopa and Levodopa tablets on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Sinemet(R) tablets.

Carbidopa and Levodopa tablets are used in the treatment of Parkinson's disease and syndrome. These generic versions of Carbidopa and Levodopa 10 mg / 100 mg, 25 mg / 100 mg, and 25 mg / 250 mg tablets are bioequivalent to Sinemet(R) tablets distributed by Bristol-Myers Squibb. According to IMS Data, these strengths of Carbidopa and Levodopa had US. sales of approximately $70 million for the 12-month period ended June 2008.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to add to our product portfolio by launching Carbidopa and Levodopa tablets immediately to the marketplace. We continue to focus on working towards expanding our product offering as quickly and effectively as possible."

Sinemet(R) is a registered trademark of Merck & Co.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.

Caraco Pharmaceutical Laboratories, Ltd.

CONTACT: Daniel Movens, +1-313-871-8400, or Thomas Versosky,+1-313-556-4150, both of Caraco Pharmaceutical Laboratories, Ltd.

Web site: http://www.caraco.com/

Source: PRNewswire-FirstCall

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