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    Strides Pharma gets USFDA warning letter for Puducherry facility

    Farhat NasimWritten by Farhat Nasim Published On 2019-07-03T11:38:37+05:30  |  Updated On 3 July 2019 11:38 AM IST
    Strides Pharma gets USFDA warning letter for Puducherry facility

    The 10 abbreviated new drug applications (ANDAs) pending approval from the Puducherry facility will get deferred till the site is reclassified, Strides Pharma added.


    New Delhi: Drug firm Strides Pharma Science Tuesday the US health regulator has issued a warning letter to the company for its Puducherry facility.


    The company has now received a warning letter from the United States Food and Drug Administration (USFDA) relating to the Puducherry facility, Strides Pharma Science said in a BSE filing.




    The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator.


    The company said its Puducherry site currently produces six products which will not get impacted by the current development.


    Also Read: Strides Pharma to sell Australian business for Rs 1900 crore


    However, the 10 abbreviated new drug applications (ANDAs) pending approval from the Puducherry facility will get deferred till the site is reclassified, the company added.


    Strides said it is committed to the highest standards of quality and compliance, and will work collaboratively with the USFDA to resolve all issues addressed in the warning letter.


    The company said it retains its growth guidance for the US market.


    Earlier, in May 6, 2019, the company had said that the US health regulator had classified its inspection of the company's Puducherry facility as "Official Action Indicated".


    Also Read: Non-compliance of norms: USFDA recommends action against Strides Pharma Puducherry facility

    ANDAsBSEpharma newspharma news indiaStrides PharmaStrides Pharma PuducherryStrides Pharma Sciencestrides warningUSFDAwarning letter
    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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