Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Provides Update on Remediation Activities

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.

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. Without limitation, the words "believe" or "expect" and similar expressions are intended to identify forward-looking statements. 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, including Part I, Item 1A of our most recent Form 10-K, and include but are not limited to: (i) that the information is of a preliminary nature and may be subject to further adjustment; (ii) not obtaining FDA approval for new products or delays in receiving FDA approvals; (iii) governmental restrictions on the sale of certain products; (iv) dependence on key personnel; (v) development by competitors of new or superior products or cheaper products or new technology for the production of products or the entry into the market of new competitors; (vi) market and customer acceptance and demand for new pharmaceutical products; (vii) availability of raw materials in a timely manner, at competitive prices, and in required quantities; (viii) timing and success of product development and launch; (ix) integrity and reliability of the Company's data; (x) lack of success in attaining full compliance with regard to regulatory and cGMP compliance; (xi) dependence on limited customer base; (xii) occasional credits to certain customers reflecting price reductions on products previously sold to them and still available as shelf-stock; (xiii) possibility of an incorrect estimate of charge-backs and the impact of such an incorrect estimate on net sales, gross profit and net income; (xiv) dependence on few products generating majority of sales; (xv) product liability claims for which the Company may be inadequately insured; (xvi) subjectivity in judgment of management in applying certain significant accounting policies derived based on historical experience, terms of contracts, our observations of trends of industry, information received from our customers and other sources, to estimate revenues, accounts receivable allowances including chargebacks, rebates, income taxes, values of assets and inventories; (xvii) litigation involving claims of patent infringement; (xviii)  material litigation from product recalls; (xix) the purported class action lawsuits alleging federal securities laws violations; (xx) delays in returning the Company's products to market, including loss of market share; (xxi) excessive dependency for revenues on the Marketing Agreement and Distribution and Sale Agreement, both signed with Sun Pharma; (xxii) excessive dependency on Sun Pharma and other third parties for manufacture of Caraco owned products; and (xxiii) other risks identified in this report and identified from time to time in our  periodic 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.Contacts:Caraco Pharmaceutical - Thomas Versosky - P: (313) 556-4150

SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Caraco Pharmaceutical Laboratories, Ltd. Announces Extension and Future Termination of Distribution Agreements with Sun Pharma
2. Independent Committee of Caraco Board Retains Independent Advisors for Consideration of Sun Pharma Proposal to Purchase Outstanding Shares and Caraco Acknowledges Filing of Purported Class Action Lawsuits
3. Independent Committee of Caraco Board to Consider Sun Pharma Proposal to Purchase Outstanding Shares
4. Caraco Receives Sun Pharma Proposal to Purchase All Outstanding Shares
5. Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Second Quarter and First Six Months of Fiscal Year 2011
6. Caraco Pharmaceutical Laboratories, Ltd. Announces Change to Executive Team as G. P. Singh to Assume Position of CEO Effective November 1, 2010 and Update on Remediation Status
7. Caraco Pharmaceutical Laboratories, Ltd. Announces Appointment of Eddie Munson to Board of Directors
8. Caraco Pharmaceutical Laboratories, Ltd. Announces G.P. Singh Sachdeva Is Appointed as Chief Operating Officer
9. Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Flomax®
10. Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Wellbutrin SR® Extended Release Tablets
11. Caraco Pharmaceutical Laboratories, Ltd. Receives Notice Regarding NYSE Amex Continued Listing Standards
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015  Figure 1, a free mobile-first ... medical cases, has launched a new completely redesigned web ... version allows radiologists, who work primarily on a desktop, ... engage with its radiologist user base, Figure 1 is ... North America (RSNA) Annual Meeting. ...
(Date:11/24/2015)... , Nov. 24, 2015  Family Rentals, a ... announced the launch of their newly designed, mobile-responsive ... --> Logo ... --> --> Now, renting essential ... and vacation, just got a whole lot easier ...
(Date:11/24/2015)... -- The uptake of recently approved and pipeline premium products ... market growth to 2021, says GBI Research . ... for Type 1 Diabetes Mellitus (T1DM), will be a key driver of ... --> The uptake of recently approved and pipeline premium ... of market growth to 2021, says GBI Research ...
Breaking Medicine Technology:
(Date:11/24/2015)... , ... November 24, 2015 , ... ... the Business Action on Health Awards, bestowed annually to the world’s best corporate-supported ... commended companies at Global Health Council’s Landscape Symposium held in Washington D.C and ...
(Date:11/24/2015)... ... 2015 , ... The OSHA Training Center at Chabot-Las ... in Northern California, is calling on retail employers to implement safety measures to ... volume of sales and shoppers rapidly expands, retailers are strongly encouraged to develop ...
(Date:11/24/2015)... ... , ... There’s nothing better than giving the gift of green this holiday ... , This year, gardens are popping up in the most unexpected places. A variety ... Gardens’ African Keyhole Garden Bed ($499) , Water conscious gardeners – and that should ...
(Date:11/24/2015)... ... November 24, 2015 , ... Wireless Analytics, an ... announced new 24-hour weekday support capability. The “all hours” offering was introduced ... international customers, and to enhance after-hours support available in the US. , Available ...
(Date:11/24/2015)... ... , ... Take the audience on a journey with TransFrame Cloud from Pixel Film ... images without ever setting a single keyframe in Final Cut Pro X. Design smooth and ... to change the angle and depth of field to create a unique viewing perspective. , ...
Breaking Medicine News(10 mins):