Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Enters Into Consent Decree with FDA Providing Path to Resume Manufacturing Operations
Date:9/29/2009

DETROIT, Sept. 29 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) announced today that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company's drug manufacturing operations. The decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Detroit area facilities. The Company is working expeditiously to satisfy the requirements of the decree and has already retained independent cGMP experts for review of the Company's operations and to facilitate a successful result.

Under terms of the consent decree, Caraco's cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the decree and regulations and can resume operations. Nothing in the decree prohibits Caraco from distributing FDA approved drug products that are manufactured by third parties.

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: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or less expensive products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, material litigation from product recalls, the purported class action lawsuits alleging federal securities laws violations, delays in returning the Company's products to market, including loss of market share, increased reserves against the FDA-seized inventory, and other risks identified in this report and from time to time in our periodic reports and registration statements. 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.

SOURCE Caraco Pharmaceutical Laboratories, Ltd.


'/>"/>
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
4. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
7. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
8. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
9. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
10. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
11. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... Amarantus BioScience Holdings, Inc. ... Regenerative Medicine, Neurology and Orphan Diseases, today announced that President & ... upcoming investor conferences: SeeThru Equity MicroCap Conference   ... New York City , NY When: Tuesday, May ... Conference   Where: Grand Hyatt Hotel, 109 East 42 ...
(Date:5/26/2016)... NASHVILLE, Tenn. , May 26, 2016 ... provider of software and analytics, network solutions ... healthcare, today announced it entered into a ... leading provider of outpatient software solutions and ... surgery centers, specialty hospitals and rehabilitation clinics ...
(Date:5/25/2016)... , Germany and GERMANTOWN, ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt Prime Standard: ... licensing and co-development agreement with Therawis Diagnostics GmbH to develop ... be to develop and market PITX2 as a marker to ... high-risk breast cancer patients. "We are pleased to ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 2016 , ... This campaign aims to provide a path to improved education ... control and change. , As nearly 795,000 Americans suffering from a new or recurrent ... Plus, with an estimated 129,000 of these people dying from stroke, it’s become our ...
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed at nurses and employees ... stories, courtesy of leaders in the nursing and health care industry. It also ... advocates and associations—namely Jones & Bartlett Learning. , Jones & Bartlett Learning is ...
(Date:5/26/2016)... ... May 26, 2016 , ... Despite last week’s media reports ... Yellen and company to wait until March 2017 for an interest rate increase, according ... Robinson College of Business. , “The Federal Open Market Committee (FOMC) dot charts are ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... and clinical outcomes, hosted members and suppliers for its inaugural Member Conference at ... on their mission of elevating the operational health of America’s healthcare providers. , ...
(Date:5/26/2016)... Florida (PRWEB) , ... May 26, 2016 , ... ... House® Project offering a new model of care for living and healing, celebrated ... core values: Meaningful Life in a Real Home provided by Empowered Staff. , “This ...
Breaking Medicine News(10 mins):