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    Sun Pharma gets one observation from USFDA for Baska plant

    Farhat NasimWritten by Farhat Nasim Published On 2019-03-26T09:40:16+05:30  |  Updated On 26 March 2019 4:10 AM GMT
    Sun Pharma gets one observation from USFDA for Baska plant


    The Baska injectibles plant had recently filed for approvals to sell its products in the US, which is currently Sun Pharma's biggest market. The manufacturing plant is located near the company's Halol plant which is already facing regulatory issues from the US health regulator.


    New Delhi: Drug major Sun Pharma Monday said it has received one observation from the US health regulator for its Baska manufacturing facility in Gujarat.


    In a regulatory filing, the Mumbai-based company said the US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) of Baska facility from January 28 to February 5, 2019.


    Read Also: Setback to Sun Pharma: NPPA refuses to give relief of price cap exemption for Gemcitabine



    "At the conclusion of the inspection, the USFDA issued a Form 483, with one observation for which the company has submitted the response," it added.

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

    The Baska injectibles plant had recently filed for approvals to sell its products in the US, which is currently Sun Pharma's biggest market. The manufacturing plant is located near the company's Halol plant which is already facing regulatory issues from the US health regulator.

    Read Also: NPPA fixes retail price of Sun Pharma Baclofen Oral Solution



    Baska manufacturing gujarat Baska plant BSE PAI pharma pharma news pharma news india pre-approval inspection Sun Pharma Sun Pharma shares US US Food and Drug Administration US health US health regulator USFDA 
    Source : PTI

    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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