Jazz Pharma has officially opened a €50 million manufacturing plant near Athlone.
Work on the Athlone facility began in February 2014 but it has now received the regulatory approval necessary from both the US Food and Drug Administration and Ireland Health Products Regulatory Authority to start manufacturing.
It is the first directly owned, managed and operated manufacturing facility built by the company.
The Nasdaq-listed specialty pharma group is headquartered in Dublin following its acquisitions of Azur Pharma in 2012.
Its main products are a narcolepsy drug, Xyrem, Erwinase which is used to treat certain forms of leukaemia, and defitelio/defibrotide, which is used to address complications in stem cell transplant patients.
It employs 100 people here and says it expects to add a further 50 jobs over the next three years. The company also has operations in the US, England and Italy.
"This new manufacturing and development facility is an investment in Ireland and also an investment in our growing global infrastructure, which will enable us to more closely oversee and control the process of bringing high quality products to patients," said chief executive Bruce Cozadd.
“The remarkable pro-business environment in Ireland facilitates investments like this one,” he added.
Speaking at the event, Minister Mary Mitchell O’Connor said that having a global pharmaceutical company establish such a facility in Co Roscommon was “hugely significant, demonstrating serious commitment by the company to the region”.
Barry Heavey, IDA Ireland's global head of life sciences, welcomed what he said was a significant and strategically important development for Jazz Pharmaceuticals.
“It demonstrates Ireland’s ability to support manufacturing for this sector in regional locations and confirms the company’s commitment to expanding its presence in Ireland,” he said.