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About EirGenix
Milestone
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Milestone
2018
2017
2016
2015
2014
2013
2011
2008
2006
2005
2018
Received the "Asia's Best CMO" awarded by Biologics Manufacturing Asia (BMA).
EG12014 was approved for phase III clinical trial by US FDA and Taiwan FDA.
2017
Held beam-raising ceremony for Zhubei plant
Received "2017 Biomarker Industry Potential Benchmark Award" by Taiwan Bio Industry Organization
EG12014 European Phase I clinical trial study showed positive results.
Received "Grand Winner of Best Bioprocess Excellence in Taiwan” by Biologics Manufacturing Asia (BMA)
Antibody Drug Conjugate platform received excellence award by Biologics Manufacturing Asia (BMA)
Received official certificate from Japan MHLW of foreign manufacturer of biologics, which granted biologics manufactured by EirGenix in Taiwan.
2016
EG12014 was approved for the European Phase I clinical trial.
Received financial support around NT$850 million for Zhubei plant
Began Zhubei plant’s construction
EirGenix cooperate stock was officially listed on Stock Exchange (6589).
2015
Completed follow-up inspection by Taiwan FDA
Applied EG12014 for the European Phase I clinical trial.
Received the Gold Prize for in "Biomedical and New Agricultural Industry Award".
2014
EirGenix's received PIC/S GMP certificate from Taiwan FDA.
2013
Predecessor's (DCB-Biopharmaceutical Pilot Plant) microbial production facility received cGMP certificate from Taiwan FDA.
Acquired DCB-biopharmaceutical pilot plant.
Updated the US FDA Type V Drug Master File and Taiwan FDA registration information.
Completed follow-up inspection by the Taiwan FDA
2012
EirGenix Inc. was founded.
2011
Predecessor (DCB-Biopharmaceutical Pilot Plant) received BioPharm 2011 Asia Best CMO Award.
Predecessor (DCB-Biopharmaceutical Pilot Plant) completed follow-up inspection by Taiwan FDA.
2008
Predecessor (DCB-Biopharmaceutical Pilot Plant) completed follow-up inspection by Taiwan FDA.
2006
Predecessor (DCB-Biopharmaceutical Pilot Plant) registered Drug Master File to US FDA (DMF no. 19164).
NOTE: Type V DMF is used for sterile manufacturing plants and contract facilities for biotech products.
2005
Predecessor (DCB-Biopharmaceutical Pilot Plant) received cGMP certificate from Taiwan FDA.
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