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    USFDA finds adulteration, violations of CGMP regulations at Strides Pharma Puducherry plant

    Farhat NasimWritten by Farhat Nasim Published On 2019-07-17T13:59:42+05:30  |  Updated On 17 July 2019 1:59 PM IST
    USFDA finds adulteration, violations of CGMP regulations at Strides Pharma Puducherry plant

    The FDA's warning letter dated July 1, comes months after several Indian drugmakers including Sun Pharmaceutical Ltd and Dr Reddy's Laboratories Ltd were named in a US lawsuit against Israeli drugmaker Teva Pharmaceutical Industries Ltd accusing it of conspiring to inflate drug prices and stifle competition for generic drugs.


    New Delhi: The US Food and Drug Administration (FDA) said it found adulteration and "significant violations" of current good manufacturing practice (CGMP) regulations at Strides Pharma Sciences Ltd's plant in Puducherry in South India.


    Strides shares fell 5% in early trade on July 17.


    The drugmaker was caught trying to dispose quality-control records, the FDA said in a letter made public on July 16.


    "Our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of documents," it said.


    The FDA's warning letter dated July 1, comes months after several Indian drugmakers including Sun Pharmaceutical Ltd and Dr Reddy's Laboratories Ltd were named in a US lawsuit against Israeli drugmaker Teva Pharmaceutical Industries Ltd accusing it of conspiring to inflate drug prices and stifle competition for generic drugs.


    Also Read: Strides Pharma gets USFDA warning letter for Puducherry facility


    Last month, Aurobindo Pharma Ltd was warned by the FDA for ignoring impurities in an active ingredient it produced. Hyderabad-based Aurobindo recalled contaminated valsartan in January and in March.


    The destruction of quality-control paperwork and a lack of adequate documentation that its medicines are safe "raise questions about the effectiveness" of Strides's quality unit "and the integrity and accuracy" of its data, Francis Godwin, director of the FDA's Office of Manufacturing Quality, wrote in the letter.


    On July 2, Strides shares slumped after it said it received a warning letter from the USFDA, it did not disclose the content of the letter at that time.


    Strides did not immediately respond to a request for comment, while the USFDA was unavailable for further comments outside regular business hours.

    Aurobindo PharmaCGMP observationsDr Reddy's Labsdrug price conspiracydrug qualitygeneric drugpharmapharma newspharma news indiaprice inflationPuducherry plantsafety of drugsStrides Pharmastrides pharma puducherry plantStrides Pharma ScienceSun PharmaTeva PharmaUSFDAUSFDA warningValsartan
    Source : Reuters

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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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