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:5/21/2020)... PENNSAUKEN, N.J (PRWEB) , ... May 21, 2020 ... ... fully integrated aluminum services resource, donated its second COVID-19 drive-through testing shelter in ... partnership with the Camden County Freeholders and Connor Strong & Buckelew and is ...
(Date:5/21/2020)... ... May 21, 2020 , ... Sindledecker ... The offices had been closed due to the coronavirus pandemic and the practice ... field. The office has remained open only for emergency needs and the staff, ...
(Date:5/21/2020)... ... May 21, 2020 , ... MedVet, a leader in emergency and ... located at 601 Showers Dr., Mountain View, CA in June 2020. MedVet Mountain View ... pet care in the Silicon Valley and broader Santa Clara County areas. Concurrent to ...
Breaking Medicine Technology:
(Date:5/21/2020)... BOYNE CITY, Mich. (PRWEB) , ... May 21, 2020 , ... ... Arm-Pull, a hands-free door opener that allows users to open swing-style doors without ... swing-style doors and allows people to pull the door open using their forearm, wrist ...
(Date:5/21/2020)... , ... May 21, 2020 , ... ... an industry leader in cancer biomarker assays, announced today that Cigna has added ... Corporation is a global health service company dedicated to improving the health, well-being, ...
(Date:5/21/2020)... ... May 21, 2020 , ... A Safe Haven Foundation (ASHF) has been selected ... AbbVie COVID-19 Community Resilience Fund. The fund was created in March to help nonprofits ... workers in service to vulnerable populations in hard-hit communities. , “We are humbled ...
(Date:5/21/2020)... ... May 21, 2020 , ... In response to Michigan Governor ... May 28th and all businesses will be required to have covid-19 employee screening, ... , As an essential business, AmeriCare Medical began this precautionary process in early ...
(Date:5/21/2020)... ... 2020 , ... The Rise of Mental Health and Substance Abuse During COVID-19, ... adjustments, needless to say, more complications. With rising deaths, more confirmed cases every day, ... be hard to escape and find peace. Adding to these persistent stressors are quarantine ...
Breaking Medicine News(10 mins):