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
    • Lupin gets USFDA...

    Lupin gets USFDA warning letter for Mandideep Unit-1 facility

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-09-19T13:07:54+05:30  |  Updated On 19 Sept 2019 1:07 PM IST
    Lupin gets USFDA warning letter for Mandideep Unit-1 facility

    Commenting on the same, Lupin said, "The Company does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from operations of this facility."


    Mumbai: Drug firm, Lupin Ltd. today said it has received a warning letter from the U.S. Health regulator for its Mandideep (Unit-1) facility.


    This is subsequent to an earlier intimation received from the U.S. Food and Drug Administration (USFDA) in March 2019 wherein the agency had classified its inspection conducted at the said facility in December 2018 as "Official Action Indicated" (OAI).


    There are no DMF and ANDA applications pending review or approval from the Mandideep (Unit-1) facility.


    Commenting on the same, Lupin said, "The Company does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from operations of this facility."


    "We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities, " Lupin added.


    Read Also: Lupin: FIRST to win Canadian approval for a generic version of Inderal-LA capsules


    Based in Mumbai, the company’s key focus areas include paediatrics, cardiovascular, anti-infectives, diabetology, asthma, and anti-tuberculosis.


    Read Also: Lupin gets USFDA nod for a generic version of Edecrin tablets to treat Edema in US

    ANDAcGMPDMFLupinLupin inspectionlupin Mandideeplupin observationMandideepMandideep facilityoaiOfficial Action Indicatedpharmapharma companypharma newspharma news indiaregulation 30SEBIUSFDAUSFDA letterusfda lupinUSFDA warning

    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

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

      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