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    • Biocon gets EIR from...

    Biocon gets EIR from USFDA for Bengaluru biologics unit

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-11-06T09:19:13+05:30  |  Updated On 16 Aug 2021 3:18 PM IST

    New Delhi: Biopharmaceutical firm Biocon on Tuesday said it has received an establishment inspection report (EIR) from the US health regulator for its biologics drug product unit at Bengaluru. The US Food and Drug Administration has said the inspection is closed. The company had undergone good manufacturing norms compliance inspection of the unit from August 22-30, Biocon said in a regulatory filing.


    Commenting on the development, Biocon Biologics CEO Christine Hamacher said, "The EIR for this facility reaffirms our manufacturing capabilities for high quality biosimilars to serve the needs of patients in the US".


    Read Also: Biocon bags sixth place in Global Biotech Employers ranking for 2019


    The facility is a strong building block for the company's USD 1 billion revenue target, Hamacher added.


    The USFDA had in October approved Biocon's new drug product filing for biosimilar Trastuzumab 150mg vials at the biologics facility in Bengaluru following a pre-approval inspection in September, the company said.


    Read Also: Biocon arm signs licensing agreement with Evotec for biosimilar asset

    Bioconbiologics drug product unitbiosimilarsChristine HamacherEIREstablishment Inspection Reportpharmapharma companypharma newsTrastuzumabUS health regulatorUSFDA
    Source : PTI

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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