All NewsTop NewsIndustry NewsBio/Pharma NewsSupplier NewsNews from Europe
All PublicationsPharmTechPharmTech Europe
MarketplaceFront & CenterICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Deals, Development and Manufacturing
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
Global Perspectives
Intellectual Property & Patents
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
Mergers and Acquisitions
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Deals, Development and Manufacturing
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
Global Perspectives
Intellectual Property & Patents
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
Mergers and Acquisitions
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Ranbaxy Signs Consent Decree with FDA

December 29, 2011
By Pharmaceutical Technology Editors
Article

On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland.

On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland.

In addition, Ranbaxy will make a provision of $500 million to resolve all potential civil and criminal liability in connection with an investigation by the US Department of Justice (DOJ). The department was evaluating allegations of conspiracy, false statements, and healthcare fraud at the company. DOJ launched the investigation after federal officials, reportedly including representatives of FDA, searched Ranbaxy’s New Jersey offices in 2007.

The consent decree follows FDA’s accusation in February 2009 that Ranbaxy’s Paonta Sahib, India, facility had falsified data and test results in approved and pending drug applications. FDA invoked its Application Integrity Policy (AIP) and stopped all substantive scientific review of new and pending drug-approval applications containing data generated by the facility.

As part of the AIP, the agency asked Ranbaxy to resolve the questions of data integrity and reliability. The company was expected to initiate a corrective action operating plan to certify the integrity and reliability of data from the Paonta Sahib facility. Malvinder Mohan Singh stepped down as chairman, CEO, and managing director of Ranbaxy about two months after FDA’s actions.

“While we were disappointed by the conduct that led to the FDA’s investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes,” said Arun Sawhney, Ranbaxy CEO and managing director, in a press release. “Ranbaxy’s new management team, and its new majority shareholder, Daiichi Sankyo, are committed to the utmost levels of professionalism and integrity, and to ensuring that all Ranbaxy facilities meet the high standards that patients, prescribers, and the public expect from a leading global generic pharmaceutical company. We look forward to continuing to work cooperatively with the FDA to strengthen the public trust in our company.”

See related Pharm Tech articles:

Ranbaxy’s New Year’s Resolution (blog)

FDA Halts Review of Applications from Ranbaxy's Paonta Sahib Plant (ePT)

Ranbaxy Comments on Merck KGaA Generics Rumors, Confirms Federal Raid in NJ (ePT)

Recent Videos
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Related Content

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

New CBER Director Appointed

Susan Haigney
May 7th 2025
Article

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.


Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.


White House | Image Credit: © Zack Frank - stock.adobe.com

Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

Patrick Lavery
May 7th 2025
Article

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.


Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

Jill Murphy
November 14th 2023
Podcast

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.


Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

GSK Previews Oral and Poster Abstracts for ATS International Congress

Patrick Lavery
May 5th 2025
Article

The company is presenting data related to its medications designed to advance the prevention and treatment of asthma and COPD.


Image Credit: © Kiattisak – stock.adobe.com

Authentic Intelligence: Finding Diverse Talent in the Age of AI

Patrick Lavery
May 4th 2025
Article

The pandemic made it daunting for companies to retain talent and then find it anew, but just as that cloud is lifting and workforce diversity is being embraced, AI beckons as a new challenge.

Related Content

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

New CBER Director Appointed

Susan Haigney
May 7th 2025
Article

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.


Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.


White House | Image Credit: © Zack Frank - stock.adobe.com

Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

Patrick Lavery
May 7th 2025
Article

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.


Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

Jill Murphy
November 14th 2023
Podcast

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.


Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

GSK Previews Oral and Poster Abstracts for ATS International Congress

Patrick Lavery
May 5th 2025
Article

The company is presenting data related to its medications designed to advance the prevention and treatment of asthma and COPD.


Image Credit: © Kiattisak – stock.adobe.com

Authentic Intelligence: Finding Diverse Talent in the Age of AI

Patrick Lavery
May 4th 2025
Article

The pandemic made it daunting for companies to retain talent and then find it anew, but just as that cloud is lifting and workforce diversity is being embraced, AI beckons as a new challenge.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.