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As previously disclosed, the warning letter was issued as a follow up tothe last FDA inspection of the Company's manufacturing facility in Detroit,Michigan which was initiated in May 2008. Until the Company's responses to theobservations have been clarified and explanations provided to the satisfactionof the FDA, the FDA may in the near term withhold approval of pending new drugapplications listing the facility as the manufacturer. The Company's sales ofcurrent products continue in the normal course of business.
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The Company is committed to working cooperatively and expeditiously withthe FDA to resolve the matters indicated in its letter.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,manufactures, markets and distributes generic and private-labelpharmaceuticals to the nation's largest wholesalers, distributors, drugstorechains and managed care providers.
Safe Harbor: This news release contains forward-looking statements madepursuant to the safe-harbor provisions of the Private Securities LitigationReform Act of 1995. Such statements are based on management's currentexpectations and are subject to risks and uncertainties that could causeactual results to differ materially from those described in theforward-looking statements. These risks and uncertainties are contained in theCorporation's filings with the Securities and Exchange Commission, includingItem 1A to the Corporation's annual report on Form 10-K, and include, but arenot limited to: information of a preliminary nature that may be subject toadjustment, potentially not obtaining or delay in obtaining FDA approval fornew products, governmental restrictions on the sale of certain products,development by competitors of new or superior products or less expensiveproducts or new technology for the production of products, the entry into themarket of new competitors, market and customer acceptance and demand for newpharmaceutical products, availability of raw materials, timing and success ofproduct development and launches, dependence on few products generatingmajority of sales, product liability claims for which the Company may beinadequately insured, and other risks identified in this report and from timeto time in our periodic reports and registration statements. Theseforward-looking statements represent our judgment as of the date of thisreport. We disclaim, however, any intent or obligation to update ourforward-looking statements.
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
