Caraco Pharmaceutical Laboratories, Ltd. Receives FDA Warning Letter
Until the Company's responses to the observations have been clarified andexplanations provided to the satisfaction of the FDA, the FDA may in the nearterm withhold approval of pending new drug applications listing the facilityas the manufacturer.
Caraco intends to respond promptly and timely to the FDA within fifteenbusiness days. The Company is committed to working cooperatively andexpeditiously with the FDA to resolve the matters indicated in its letter.Caraco is confident that any remaining concerns will be addressed andresolved.
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 the forward-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. These forward-looking statements represent our judgment as of the date of this report. Wedisclaim, however, any intent or obligation to update our forward-lookingstatements.
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
You May Also Like