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Caraco Pharmaceutical Laboratories, Ltd. Provides Update on Remediation Activities

Mon, 01/03/2011 - 4:34am
Bio-Medicine.Org

DETROIT, Jan. 3, 2011 /PRNewswire/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) announced that based on remediation efforts to date, it does not expect to commence the manufacture and distribution of products from its Detroit facility by the end of Caraco's Fiscal Year 2011, ending March 31, 2011. The Company had previously disclosed its belief that two products would commence manufacture in the Detroit facility prior to the end of Fiscal 2011. As provided under the terms of the Consent Decree of Condemnation, Forfeiture and Permanent Injunction entered into with the FDA on September 29, 2009, before resuming the manufacture and distribution of any product from the Company's facilities, a number of significant steps and processes are required to be completed, and certifications and approvals from both outside experts (current good manufacturing practice "cGMP" consultants) and the FDA are to be obtained.  In evaluating and discussing with the cGMP experts the remediation steps completed to date and those yet to be completed, the Company has determined that it will not be able to begin the manufacture and distribution of products by the end of Fiscal Year 2011.  The Company's remediation efforts towards the resumption of manufacturing and distribution from its facilities are still ongoing, but the Company is unable to predict when such manufacturing and distribution will resume.  As previously disclosed, and as always is the case in matters such as these, there is no assurance that the remediation efforts will be successful or result in resolution of the FDA compliance issues.

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

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