Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • Latest News
    • FDA warns Emcure...

    FDA warns Emcure Pharma, cites repeated data fudging at plant

    Written by savita thakur thakur Published On 2016-03-18T11:19:27+05:30  |  Updated On 18 March 2016 11:19 AM IST
    FDA warns Emcure Pharma, cites repeated data fudging at plant


    Mumbai: The US Food and Drug Administration (FDA) has warned Indian generic drugmaker Emcure Pharmaceuticals, saying it repeatedly fudged test records at its plant in western India, in another case of a pharmaceutical firm in the country facing such action.

    In a letter, the FDA said its staff inspected Emcure's plant at Hinjwadi, Pune, where the company makes injectable drugs, between January 27 and February 4 last year and found "significant violations" of standard manufacturing practices.

    The agency had already banned imports from the plant in July, except for some drugs, such as the cancer medicine carmustine, the antipsychotic haloperidol, and the antibiotic amikacin.

    It is one of 42 drug-making factories in India that the FDA has banned in recent years as it stepped up inspections of foreign suppliers. The increased scrutiny has hit growth at Indian companies the hardest, as the country supplies nearly 40 percent of the medicines sold in the United Stares.

    "We observed multiple examples of incomplete, inaccurate, or falsified laboratory records," the FDA said in the letter dated March 3 addressed to Emcure's Chief Executive Satish Mehta and posted on the U.S. agency's website on Wednesday.

    Unlisted Emcure, in which U.S. private equity firm Bain Capital has a stake, declined to comment on the FDA letter.

    The drugmaker committed to the FDA in 2014 that it would improve processes at its plant, the FDA said. Yet, in its 2015 inspection the FDA said it found "continuing practices of data falsification and manipulation at your facility, indicating that previous corrections were ineffective".

    The fabricated records were of tests that Emcure was required to conduct to ensure proper environmental control was maintained while aseptic filling of drug batches, so that the products wouldn't become contaminated, the FDA said.

    A plant employee told FDA inspectors that fabrication of records relating to environmental controls was "routine and due to work pressure", the agency said.

    Emcure, which operates eight plants in India, supplies medicines to the United States, Europe, Brazil and Japan, according to its website.

    The company has 15 days to respond to the FDA's letter on the corrective actions it will take on the concerns raised. It was not immediately clear what the consequences are if that deadline is not met.



    Source : Reuters
    EmcureSatish MehtaUS Food and Drug AdministrationUSFDA

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    savita thakur thakur
    savita thakur thakur
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok