Our History

October 2013

EirGen expands its facilities in Waterford, doubling its state-of-the-art space in the southeast and future-proofing against ongoing industry demands.

May2013

May 2013

EirGen undergoes its fourth inspection by the Irish Health Products Registry Authority (HPRA, formerly the Irish Medical Board). There were no observations, further confirming its excellence. 

September2012

September 2012

EirGen’s facility and first 5 products are submitted to the US FDA agency for approval and inspection.

February2012

February 2012

After submitting two oncology product licenses to Japanese PMDA, the licenses are approved. This is EirGen’s first venture into Japan. 

January2011

January 2011

EirGen receives facility and products approval from the US FDA on the back of September 2010 inspection. Passing inspection at the first attempt demonstrates a huge commitment to quality.

September2010

September 2010

EirGen’s facility and first 5 products are submitted to the US FDA agency for approval.

December2009

December 2009

EirGen achieves its first commercial license approval to sell product from Canadian Health authorities. Meanwhile, the company stages its first commercial product launch in the EU, and submits its fifth oncology product license to the US FDA.

February2008

February 2008

After forging ahead with its initial research and development, EirGen is ready tosubmit its first Pan-European License (EIR012 application).

March2006

March 2006

EirGen beginsconstruction of its facilities, with its first successful regulatory audit following in August.We hit the ground running!