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Milestone

The Taichung site was built in 2012. The GMP facility has been approved by the Taiwan Food and Drug Administration (TFDA), which was effective on April 18, 2013. In 2015, TFDA did the periodic inspection and renewed the certification on March 29, 2016. Moreover, in 2017, EMA authority conducted the pre-approval inspection to Taichung plant and no critical observations were found.

2012

  • Jun

    Ground Breaking

  • Oct

    Plant Opening

2013

  • Jan

    TFDA Inspection

  • Apr

    The plant obtained the first PIC/S cGMP certificate for protein drug in Taiwan

2014

  • Jan

    Initiate key process control program

  • Sep ~ Dec

    Ropeginterferon alfa-2b (P1101) Process Validation completed

2015

  • Nov

    TFDA Re-Inspection; the plant obtained the certificate in January 2016 

2016

  • Jan

    Initiate quality improvement program under consultants’ supervision from Europe

2017

  • Jan

    Initiate 6S management program

  • Feb

    Submission of MAA application filing to EMA completed

  • Mar

    Vetter Pharma (Germany) Inspection with no critical observations; AOP (Austria) Inspection with no critical observations

2018

  • Jan

    PharmaEssentia obtained GMP certificate by EMA

  • Apr

    −Initiate filling line establishment
    −Initiate process upgrade program

  • Jul

    Initiate DS establishment