Breaking News

EU Authorities Lift GMP Suspension at Ranbaxy’s Toansa Site

June 5, 2014

Will reinstate GMP certificate

European regulatory authorities have finalized an assessment of reported non-compliance with GMP at Ranbaxy Labs’ manufacturing site in Toansa, India. While the assessment showed a number of GMP deficiencies at the site, European regulators concluded that there has been no risk to public health from these deficiencies. European regulators reviewed the corrective measures put in place by the company and found them to be sufficient to ensure GMP compliance, and, as a result, will reinstate the GMP certificate that was suspended in January 2014.  

The assessment followed an inspection by the FDA, which revealed areas of non-compliance at the site. The European medicines regulatory network responded to the FDA’s findings, sending a team of inspectors from Germany, Ireland and the UK, along with inspectors from Switzerland and Australia to undertake an international inspection of the site.

The inspection team concluded that medicines on the EU market that have an API manufactured in Toansa were of acceptable quality presented no risk to patients. This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications.

European regulatory authorities will continue to monitor the Toansa site in collaboration with India and other regulatory authorities.
blog comments powered by Disqus
  • Staying Ahead in the Small Molecule Space

    Staying Ahead in the Small Molecule Space

    Dr. Matthew Moorcroft, VP Global Marketing, Cambrex||September 8, 2016
    Understand what is happening in the market and react accordingly

  • FDA & Drug Development

    FDA & Drug Development

    Rachelle Du2019Souza, Regulatory Heights Inc.||September 8, 2016
    You must perform the necessary due diligence to stay on top of regulatory developments

  • Patent Law  and Contract Manufacturing

    Patent Law and Contract Manufacturing

    Beverly W. Lubit, Member of the Firm, Chiesa Shahinian & Giantomasi||September 8, 2016
    Analyzing the impact of The Medicines Co. vs. Hospira Inc. decision