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Caraco Pharmaceutical Laboratories Ltd. To Market Extended Phenytoin Sodium Capsules, USP 100mg

Posted on: Friday, 15 December 2006, 15:01 CST

DETROIT, Dec. 15 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. announced today that it will market Extended Phenytoin Sodium Capsules, USP 100mg (Phenytoin ER) 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 Phenytoin ER.

Phenytoin ER is an anticonvulsant drug. It is useful in the treatment of seizures related to epilepsy and neurosurgery. This new product is the bioequivalent to Dilantin Kapseals(R), a registered trademark of Parke Davis,(Pfizer). According to IMS Data, Phenytoin ER generic and brand products combined have annual sales of approximately $170 million.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to have the opportunity to market this product as it adds value to our overall portfolio of products. We continue to focus on working towards expanding our product offering as quickly and effectively as possible. We plan to launch this product as the third entrant in the generic pharmaceutical market immediately. This will bring our total product selection to 27 different products represented by 56 various strengths."

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: 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, dependence on key personnel, 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, integrity and reliability of the Corporation's data, compliance with regard to regulatory and cGMP managing our recent rapid growth and anticipated future growth, occasional credits to certain customers reflecting price reductions on products previously sold to them and still available as a shelf-stock adjustment, possibility of an incorrect estimate of charge-backs and the impact of such an incorrect estimate on net sales, gross profit and net income, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, subjectivity in judgment of management in applying certain significant accounting policies derived based on historical experience, terms of contracts, accounts receivable allowances including chargebacks, rebates, income taxes, values of assets and inventories, litigation involving claims of patent infringement, litigation involving claims for royalties, and other risks identified in this report and identified from time to time in our reports and registration statements filed with the Securities and Exchange Commission. 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 or Jitendra Doshi, +1-313-871-8400, or AaronMiles, +1-313-556-4150, all of Caraco Pharmaceutical Laboratories

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

Source: PRNewswire-FirstCall

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