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 fili
'/>"/>

Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:1/23/2015)... 23, 2015 More than a third of reproductive-aged women ... with private insurance, filled a prescription for an opioid pain ... this week,s Morbidity and Mortality Weekly Report (MMWR). ... treat moderate to severe pain.  They are also found in ...
(Date:1/23/2015)... , Jan. 23, 2015  Now available for sale, ... 7,849,611) support that prevents ankle sprains by cushioning the ... it fits securely around the outside of any shoe ... & comfort while still offering protection against sprains. With ...
(Date:1/23/2015)... , Jan. 23, 2015  CytoSorbents Corporation (NASDAQ ... its CytoSorb® extracorporeal cytokine adsorber to reduce deadly ... the receipt of $385,642, net of transaction costs, ... the Technology Business Tax Certificate Transfer Program sponsored ...
Breaking Medicine Technology:Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3The Armor1 Ankle Roll Guard is the New Breakthrough Solution for Ankle Sprain Prevention! 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3
... body temperatures of newborns with temporal artery thermometry (forehead ... (under arm) thermometry, the clinically recommended method for this ... new study reported in Advances in Neonatal Care ... clinical analysis evaluating the accuracy of temporal artery thermometry ...
... BB&T Capital Markets served as the exclusive financial advisor ... developer, manufacturer and marketer of therapeutic footwear and related ... Global, an international provider of medical device solutions for ... Vista, Calif. Dr. Comfort generated net sales of $71.8 ...
Cached Medicine Technology:Study Finds Exergen Temporal Artery Thermometry Accurate on Newborns 2Study Finds Exergen Temporal Artery Thermometry Accurate on Newborns 3BB&T Advises Dr. Comfort on Its Sale to DJO Global in Transaction Valued at $254.6 Million 2
(Date:1/22/2015)... January 22, 2015 Juvent Sports ( ... the 2015 PGA Merchandise Show to bestow a Juvent ... female amateur golfer, Arlene McKitrick. The award commemorated and ... golf tournament win. She won her first amateur tournament ...
(Date:1/22/2015)... 20 years, Dr. David Cruz of Cruz Chiropractic Care ... about every type of injury that can result from car accidents ... years, the team at Doctors on Liens has been ... With the combined breadth of experience between the two, ...
(Date:1/22/2015)... January 22, 2015 Yesterday, Senator ... (D-Concord) and Kristin Olsen (R-Modesto) were honored by ... in advancing biotechnology, biomedical science, medical device and ... each received the “2014 Life Sciences Champion” award ...
(Date:1/22/2015)... 22, 2015 Payday lending practices in ... and cause financial distress to the states that permit ... Howard University’s Center on Race and Wealth. , While ... activity, payday loans at the same time substantially depress ...
(Date:1/22/2015)... Compare-autoinsurance.org has released a new blog post presenting a ... insurance policy . , Some types of vehicles cannot be ... newly released blog post to see if their vehicle qualifies for ... are some of the cars that cannot be covered by a ...
Breaking Medicine News(10 mins):Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Some Vehicles Cannot Be Covered By An Auto Insurance Policy! 2
... any moment may be keyed to what they expect to ... -- People like to temper their emotions to the task ... the emotions are not pleasurable ones, a new report suggests. ... for example, when they expect to complete a confrontational task ...
... ,hands on, approach and strategic ... statement, BOSTON, April 4, 2008 The Board ... of Robert Hernreich to the,organization,s board of directors. Mr. ... officially took his place on the board in,late 2007., ...
... Put Medical Equipment Providers Out of Business and,Disrupt Services ... Disabled People,in Ohio, ARLINGTON, Va., April 4, 2008 ... (DME) scheduled to be,implemented in the Cincinnati and Cleveland, ... providers out of business and will likely disrupt,services for ...
... has been reported that highlights the problems that oxidative ... can generate in relation with the pathogenesis of Alzheimer,s ... throughout the world. The results of research carried out ... from the laboratory of Professor Dr. R.B. Maccioni of ...
... than 26,000 rushing in for acute care each year, study ... well is graceful and awe-inspiring, but one misstep or misplaced ... American children end up in hospital emergency rooms due to ... the April issue of Pediatrics . , "Gymnastics has ...
... Joint Commission Campaign Urges Patients to Take an ... Ill., April 4, 2008 ,Understanding the often complex ... you can be difficult, and the consequences of,misunderstanding ... Joint Commission is launching a national campaign to ...
Cached Medicine News:Health News:Study Shows Anger Has Its Uses 2Health News:Global Action Board of Directors Announces Addition of Newest Member, Robert Hernreich 2Health News:Errors Plague Medicare 'Competitive Bidding' Program in Ohio, Says American Association for Homecare 2Health News:Errors Plague Medicare 'Competitive Bidding' Program in Ohio, Says American Association for Homecare 3Health News:Errors Plague Medicare 'Competitive Bidding' Program in Ohio, Says American Association for Homecare 4Health News:Redox-active iron is a sensor of cognitive impairment associated with Alzheimer's disease 2Health News:Young Gymnasts Tumbling and Vaulting Their Way to the ER 2Health News:Young Gymnasts Tumbling and Vaulting Their Way to the ER 3Health News:'Understanding Your Caregivers' Promotes Health Literacy 2Health News:'Understanding Your Caregivers' Promotes Health Literacy 3
... The latest in Canons DR innovations, ... DR system. With a compact and lightweight ... positioned, just like conventional screen-film cassettes. It ... that are difficult to get with fixed ...
The Oscor PACE 101 H is an external single chamber cardiac demand pacemaker. The PACE 101 H feature an option for a atrial overdrive stimulation....
... Oscors proprietary quadripolar pacing wire ... pacing and sensing in the ... two bipolar wires in one ... the atrium and ventricle are ...
... 227 T is a quadripolar ... cardiac pacing and monitoring during ... TME 227 T features tines ... which allows safe and easy ...
Medicine Products: