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    • Alkem Labs gets 8...

    Alkem Labs gets 8 USFDA observations for St Louis facility

    Farhat NasimWritten by Farhat Nasim Published On 2019-03-24T09:50:01+05:30  |  Updated On 16 Aug 2021 11:24 AM IST


    The United States Food and Drug Administration (USFDA) had issued eight observations after inspecting the company's manufacturing plant at St Louis from January 14 to February 5 this year, Alkem Labs said in a filing to BSE.


    New Delhi: Drug firm Alkem Laboratories Friday said it has received a letter from the US health regulator asking not to manufacture a particular product at its St Louis facility till a final decision is taken.


    The United States Food and Drug Administration (USFDA) had issued eight observations after inspecting the company's manufacturing plant at St Louis from January 14 to February 5 this year, Alkem Labs said in a filing to BSE.


    Read Also: Valsartan Shortage: Alkem Labs gets USFDA nod to generic Diovan



    The company had submitted a detailed response to the eight observations that it had received during the pre-approval inspection for the product, it added.

    The company, however, did not provide any details about the product.

    "The company has now received a letter from USFDA informing that the manufacturing of the said product be withheld until the completion of the final evaluation by the USFDA and the final decision of USFDA shall be communicated to the company accordingly," the drug firm said.

    Read Also: Alkem Labs gets EIR from USFDA for its Daman facility

    The said product is not being manufactured as it is awaiting approval from USFDA, it added.



    Alkem LabsBSEDrug firm Alkem Laboratoriespharmapharma newspharme news indiaShares of Alkem LaboratoriesSt Louis facilityUnited States Food and Drug AdministrationUS healthUSFDA
    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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