Navigation Links
Department of Justice files consent decree of permanent injunction against Ranbaxy
Date:1/25/2012

he affected facilities;

(2) implement procedures and controls sufficient to ensure data integrity in the company's drug applications; and

(3) withdraw any applications found to contain untrue statements of material fact and/or a pattern or practice of data irregularities that could affect approval of the application. 

In addition, the consent decree prevents Ranbaxy from manufacturing drugs for introduction to the U.S. market and for the President's Emergency Plan for AIDS Relief (PEPFAR) Program at the Paonta Sahib, Batamandi, Dewas, and Gloversville facilities until drugs can be manufactured at such facilities in compliance with U.S. manufacturing quality standards. 

"Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers," said Dara Corrigan, FDA associate commissioner for regulatory affairs. "The FDA continues to be committed to protecting consumers from potentially unsafe products that may be offered on the market."

Under this agreement, once Ranbaxy has achieved compliance with the data integrity requirements, a third party expert must conduct audits of the facilities to confirm that compliance is being maintained.  The company must authorize an individual to be responsible for all quality assurance and quality control activities to ensure that drugs have the required safety, identity, strength, quality, purity, and potency and are in compliance with the law and the decree.  In addition, they must establish an Office of Data Reliability to conduct pre-submission audits of all applications submitted from any facility after entry of the decree.

Ranbaxy has agreed to relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications, and the firm has further agreed to relinquish any 180-day marketing exclusivity that i
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Baxter Awarded Pandemic Advanced Supply Contract from the Department of Health
2. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Chester County Dairy
3. U.S. Department of Health and Human Services Completes Funding of 2006 Contract Award to CSCs DVC and Baxter
4. DuPont Provides Technology for Washington Hospital Centers Emergency Department
5. NYC Department of Healths Get Some NYC Condoms Sends Wrong Message and Misuses Tax Dollars, says MIM President Bob Peters
6. PA Department of Health Reports Rise in Flu Activity; Reminds Public of Need for Flu Shot
7. Columbia University Medical Center and Rosetta Genomics Announce Columbia Universitys Submission of the First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology for Approval to the New York State Department of Health Clinica
8. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Lebanon County Dairy
9. Pediatric Heart Transplants at Montefiore Approved by NY State Department of Health
10. Justice Department Will Not Oppose CEO Roundtable on Cancers Proposal
11. USD 12.5 m Funding for the Development of Intercells Vaccine Patch System for Pandemic Influenza From U.S. Department of Health and Human Services (HHS)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... 20, 2014  The National Association of Drug ... achieved by the real-time, pseudoephedrine (PSE) blocking system ... Log Exchange (NPLEx), automatically blocks unlawful PSE sales ... offenders and make arrests. Data released by NPLEx ... blocked the sale of more than 32,105 ...
(Date:8/20/2014)... , Aug. 20, 2014  The National Association ... latest results achieved by the real-time, pseudoephedrine (PSE) ... National Precursor Log Exchange (NPLEx), automatically blocks unlawful ... down methamphetamine offenders and make arrests. Data released ... Missouri blocked the sale of more ...
(Date:8/20/2014)... Aug. 20, 2014 Reportlinker.com ... report is available in its catalogue: ... Infection Control (Sterilization, Disinfection, Testing and ... Given the cost ... demand has increased for solutions that ...
Breaking Medicine Technology:Indiana's Stop-Sale System Achieves Significant Results In Battle Against Meth 2Missouri's Stop-Sale System Achieves Significant Results In Battle Against Meth 2The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 2The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 3The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 4The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 5The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 6
... Cetrorelix showed good safety and tolerability profile ... level,Japanese partner Shionogi initiates Phase 2b trial, ... AEterna,Zentaris Inc. along with its Japanese partner ... for a Phase 2a trial with,cetrorelix in ...
... WIRE)--Mar 22, 2007 - Nutra Pharma,Corp. (OTCBB: ... for HIV and Multiple Sclerosis has today ... received notification of,acceptance of its paper for ... conference issue., The article, entitled "Alpha-Cobratoxin as ...
Cached Medicine Technology:AEterna Zentaris Reports Positive Results with Cetrorelix in BPH,for Japanese Phase 2a Trial 2AEterna Zentaris Reports Positive Results with Cetrorelix in BPH,for Japanese Phase 2a Trial 3AEterna Zentaris Reports Positive Results with Cetrorelix in BPH,for Japanese Phase 2a Trial 4Nutra Pharma Announces Publication of Research on Treatment for,Multiple Sclerosis 2Nutra Pharma Announces Publication of Research on Treatment for,Multiple Sclerosis 3
(Date:8/21/2014)... August 21, 2014 Hunhu Healthcare, ... solutions, announced today that it has entered into a ... practices, mobile technology and predictive analytics for recruiting, leveraging ... , According to Michael Emerson , co-founder and ... two patents on the technology used in what he ...
(Date:8/21/2014)... DMG Productions announces the upcoming airing of ... Monday, August 25, 2014 at 7:00 a.m. EST and ... this episode, Innovations will go behind-the-scenes to demonstrate how ... performance. Audiences will be amazed by the park's that ... and providing access to real musical instruments. , Audiences ...
(Date:8/21/2014)... Poorly-made dental restorations – whether produced in America ... health consequences for patients. To ensure better outcomes for ... and patients have a full understanding of where their ... used in the process. , Some patients believe their ... not even think twice about where their restorations are ...
(Date:8/21/2014)... Studies find that participating in a juice ... clearer skin, more energy, refresh the taste buds, help lose ... wellness center in Beverly Hills, is excited to offer guests ... their recovery room. , β€œIt’s important that we offer patients ... surgery in our Los Angeles recovery room ,” says ...
(Date:8/21/2014)... HIPAA Secure Now! rolled out its EHR (electronic ... vendors to now offer their customers a HIPAA security ... , HIPAA Secure Now! provides risk analysis services, ... U.S. The company assesses the risks of storing and ... and device used by the practice. , HIPAA ...
Breaking Medicine News(10 mins):Health News:Hunhu Healthcare Enters into Licensing Agreement with Mayo Clinic 2Health News:Announcing New Episode Airing of Innovations on Monday August 25, 2014 via Discovery Channel 2Health News:4 Questions to Ask Before Your Next Dentist Appointment 2Health News:4 Questions to Ask Before Your Next Dentist Appointment 3Health News:Los Angeles Surgery Recovery Center Now Offering Juice Cleanses 2Health News:Los Angeles Surgery Recovery Center Now Offering Juice Cleanses 3Health News:HIPAA Secure Now! Ramps up EHR Partner Program, Helps Healthcare Providers Achieve Meaningful Use under Revised CMS Deadlines 2
... April 27 minor surgery reveals inoperable pancreatic and spinal ... Hennie Page had finally settled into a quiet life ... enjoys looking at his,paintings and frequent visits from his ... the world in years past -- leading,chartered cruises in ...
... 3 Market competition is,mounting to win the ... investigators. Field research shows that the most sought-after,clinical ... trial,invitations that they receive at their labs and ... to manage the art,and science of investigator recruitment., ...
... Grills, Photo Books and Shaving Kits Are Just a ... CVS/pharmacy,s 6,300 Convenient U.S. Locations, WOONSOCKET, R.I., June ... locations nationwide, offers,shoppers a wide selection of affordable, department ... just the right gift., "Consumers are scaling back ...
... . , Images of the inside of the intestine can ... no larger than a candy. It makes its way through the ... receiver which the patient carries on a belt. This device stores ... identify any hemorrhages or cysts. However, the camera is not very ...
... Flashpoint Medica, a full-service,healthcare advertising agency and member ... launched Flashlight Interactive, a new business unit devoted ... by agency veteran Kristen,Goelz, who joins the company ... Interactive will offer a variety of programs and,capabilities, ...
... study at the Montreal Neurological Institute at McGill University ... motor nerve cells (motor neurons) - cells that control ... a range of conditions involving nerve cell loss or ... as ALS, also known as Lou Gehrig,s disease. , ...
Cached Medicine News:Health News:Sherwood, Oregon Sailor, 78, Goes on Final Voyage 2Health News:Best Practice Toolkit Supports Recruitment of Top Clinical Investigators 2Health News:Practical Gear and Personal Gadgets: CVS/pharmacy Offers a Wide Selection of Affordable Gifts to Delight Dad This Father's Day 2Health News:Practical Gear and Personal Gadgets: CVS/pharmacy Offers a Wide Selection of Affordable Gifts to Delight Dad This Father's Day 3Health News:Magnet-controlled camera in the body 2Health News:Flashpoint Launches Flashlight Interactive, Names Kristen Goelz Head of New Division 2Health News:Finding clues for nerve cell repair 2
Inquire...
... design makes positioning quick and ... wheelchair accessible and can support ... lbs. The AIT-8B provides stable ... units and includes a motorized ...
If youre looking to expand your projection capabilities, without a major capital investment, consider Topcons CP-5D Chart Projector....
... FDA-Approved BV-1000 is the worlds ... system. With the BV-1000, Topcon ... of refracting instruments. This innovative ... binocular auto-refractor, auto-keratometer, automatic chart ...
Medicine Products: