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    Biocon Bengaluru facility clears USFDA inspection

    Farhat NasimWritten by Farhat Nasim Published On 2020-01-21T13:00:42+05:30  |  Updated On 14 Aug 2021 12:25 PM IST
    Biocon Bengaluru facility clears USFDA inspection

    The US Food and Drug Administration (USFDA) conducted a pre-approval inspection of the oral solid dosage manufacturing facility of Biocon Pharma, a subsidiary of Biocon, which was triggered by the submission of an abbreviated new drug application, the company said in a regulatory filing.

    New Delhi: Biocon on Monday said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with zero observations.

    The US Food and Drug Administration (USFDA) conducted a pre-approval inspection of the oral solid dosage manufacturing facility of Biocon Pharma, a subsidiary of Biocon, which was triggered by the submission of an abbreviated new drug application, the company said in a regulatory filing.

    Also Read: Biocon Chief Kiran Mazumdar Shaw Bags Order Of Australia Honour

    "The inspection of the Bengaluru facility, which took place between January 13 and January 17, 2020, concluded with zero observations and no Form 483 was issued," the pharma company told stock exchanges.

    "We remain committed to global standards of quality and compliance," the company spokesperson said.

    Also Read: Biocon Chief Kiran Shaw, FM Nirmala Sitharaman in a tiff over E-Cigarette ban

    Bioconusfdabengaluru
    Source : PTI

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    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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