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    • Granules gets 2...

    Granules gets 2 observation by USFDA for U.S Unit

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2018-10-30T10:48:20+05:30  |  Updated On 16 Aug 2021 3:21 PM IST

    New Delhi: Pharma firm Granules through a recent regulatory filing announced its US subsidiary has received two observations from the US health regulator following the completion of the inspection. "Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US has completed USFDA (US Food and Drug Administration) inspection from October 22-26, 2018 with two Form 483 observations,".


    Granules Pharmaceuticals, Inc will respond to the observations within this week, the company added.

    As per the USFDA, a Form 483, is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

    "This was a prior approval inspection, intended for the Abbreviated New Drug Application (ANDAs) filed by Granules Pharmaceuticals Inc. This facility is involved in development and manufacturing of finished dosages," the company said.

    Read Also: Granules India Q1 net profit up 41 percent to Rs 51.7 crore

    Abbreviated New Drug ApplicationANDAsChantillyFDCFood Drug and CosmeticGranulesUS Food and Drug AdministrationUSFDA
    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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