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    Cadila Healthcare gets 14 USFDA observations for Moraiya plant

    Farhat NasimWritten by Farhat Nasim Published On 2019-05-04T10:00:54+05:30  |  Updated On 16 Aug 2021 11:35 AM IST

    The US Food and Drug Administration (USFDA) inspected the plant from April 22, 2019 to May 3, 2019, Cadila Healthcare said in a regulatory filing.


    New Delhi: Drug firm Cadila Healthcare Friday said the US health regulator has issued 14 observations after inspecting its manufacturing facility at Moraiya in Ahmedabad.


    The US Food and Drug Administration (USFDA) inspected the plant from April 22, 2019 to May 3, 2019, the company said in a regulatory filing.


    "The inspection concluded with 14 observations. There were no repeat observations or data integrity related observations," it added.




    Prior to this, in September 2018, Cadila Healthcare's arm had received five observations from the US regulators. Medical Dialogues had reported that the inspection was made from August 20 to August 28, 2018. This was a product-specific Pre Approval Inspection. The inspection was concluded with 5 observations.



    Also Read: Cadila Healthcare subsidiary gets 5 observations from USFDA
    The company is headquartered at Ahmedabad in Gujarat state of western India. It is a manufacturer of generic drugs and was founded in 1952 by Ramanbhai Patel (1925–2001), formerly a lecturer in the L.M. College of Pharmacy, and his business partner Indravadan Modi.


    Also Read: Cadila Healthcare arm gets USFDA nod to market Ranitidine injection

    AhmedabadCadilaCadila Healthcarecadila moraiya plantCadila PharmaceuticalsData IntegrityHealthcaremanufacturing facilityMoraiyaMoraiya facilitypharmapharma newspharma news indiaRamanbhai PatelUnited StatesUSFDAzydusZydus Cadila
    Source : with inputs

    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

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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