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Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal Year 2011
Date:1/30/2011

ring companies, including an affiliate of Sun Pharma. The total number of ANDAs pending approval by the FDA as of December 31, 2010 was 33 (including four tentative approvals) relating to 29 products. Out of the 33 ANDAs pending approval, 31 (including four tentative approvals) are out of our Michigan facilities and the remaining two are from our partners' facilities.

The Company has been actively working with cGMP consultants towards the resumption of manufacturing activities at its facilities. These consultants were appointed by the Company in accordance with the previously disclosed Consent Decree of Condemnation, Forfeiture, and Permanent Injunction, which the Company entered into with the FDA on September 29, 2009. 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. As previously disclosed, and as always is the case in matters such as these, there is no assurance that the steps taken will be successful or result in resolution of the FDA compliance issues.

The Company intends to continue to augment the loss of sales of manufactured products by the sale of Caraco owned products manufactured at sites other than those of Caraco and through sales of distributed products, which are not impacted by the aforementioned actions of the FDA. The Company has transferred certain Caraco-owned products to additional manufacturing sites of Sun Pharma and its affiliates, allowing the Company to regain revenues from those products. The Company has filed with the FDA supplements to ANDAs, for its approval, for additional products to be transferred, however, there is no assurance that such approvals will be granted.

As previously disclosed, on December 3, 2010 the Company received a proposal (the "Proposal") from Sun Pharma and Sun Pharma Global, Inc. ("Su
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SOURCE Caraco Pharmaceutical Laboratories, Ltd.
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