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    • Zydus Cadila receives...

    Zydus Cadila receives warning letter from USFDA for Moraiya-based formulation facility

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-11-05T12:57:59+05:30  |  Updated On 13 Aug 2021 4:23 PM IST

    New Delhi: Drug firm Zydus Cadila on Monday said it has received a warning letter from the US health regulator for its Moraiya-based formulation facility. The company said it has already taken multiple steps after the inspection of the facility by the US Food and Drug Administration (USFDA) and would continue to take all necessary steps in future as well to ensure that the health regulator is fully satisfied with its remediation of the above facility.


    "We are confident of responding to the USFDA to address the observations within the statutory time permitted in the letter," Zydus Cadila said in a regulatory filing.


    Read Also: Zydus Cadila gets USFDA nod for Colesevelam Hydrochloride tablets for lowering cholesterol


    The warning letter does not affect the existing business of the company in the US and the existing product supplies from the Moraiya facility will continue, it added.


    The company remains committed to patient safety and meeting the expectations of regulatory compliances, the Gujarat-based firm said.


    Read Also: Zydus announces positive results from EVIDENCES IV Phase 2 clinical trial of Saroglitazar Magnesium in NAFLD and NASH

    Moraiya based formulation facilitypatient safetypharmapharma companypharma newsUS Food and Drug AdministrationUSFDAwarning letterZydus Cadila
    Source : PTI

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    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

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