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    • Laurus Labs gets 2...

    Laurus Labs gets 2 USFDA observations for Visakhapatnam facility

    Farhat NasimWritten by Farhat Nasim Published On 2019-11-10T10:00:07+05:30  |  Updated On 16 Aug 2021 2:25 PM IST

    New Delhi: Drug firm, Laurus Labs Ltd. recently said in a filing that the US health regulator has issued two observations after the inspection of its Unit – 2 (FDF&API integrated facility), located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


    The US Food and Drug Administration (USFDA) inspection was carried out from 04 November 2019 to 08 November 2019.


    "Laurus Labs Limited, a leading research and development-driven pharmaceutical company has completed the US Food and Drug Administration (USFDA) inspection of its Unit – 2 (FDF&API integrated facility), located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh, with two observations which are procedural in nature," Laurus Labs said in a filing.


    Also Read: Laurus Labs gets USFDA Establishment Inspection Report for Visakhapatnam units


    "This is a product pre-approval audit by USFDA, and no data integrity issues were observed in the inspection," the company added.


    Laurus Labs is a research & development driven and fully integrated pharmaceutical company in India. The Company is a manufacturer of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus also manufactures APIs in Oncology and other therapeutic areas.


    Also Read: USFDA completes inspection at Laurus Labs' AP unit

    Andhra PradeshAtchutapuramLaurus Labslaurus labs inspectionlaurus labs unit2pharmapharma newspharma news indiaUS health regulatorUSFDAUSFDA observationsVisakhapatnamVisakhapatnam facilityVizag

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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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