Global contract pharmaceutical development and manufacturing organisation, Almac Group, has confirmed the successful Health Products Regulatory Authority (HPRA) inspections of its European Campus in Dundalk, Ireland.
Dundalk
Following these inspections, the company is now officially licensed to conduct QP batch certification and release for both clinical trial material and commercial drug product from the Irish campus.
Additionally, the company has announced further investment at the campus including a new QC laboratory and packaging facility for commercial drug products as well as a dedicated 79,000 sq ft EU Distribution Centre for clinical trial supply.
“Achieving these successful HPRA inspections is a key milestone,” commented Alan Armstrong, CEO and chairman of the Almac Group. “In addition, the announcement today of further expansion will ensure our current and future clients receive a seamless solution with access to the EU marketplace. Crucially, this will ensure an uninterrupted service provision through any uncertainty Brexit may bring, and for the future, keeping Almac as a global leader in the life sciences sector.”
Welcoming the announcement minister for Business, Enterprise and Innovation Heather Humphreys TD said: “This decision by Almac is a great vote of confidence in Dundalk, especially coming so soon after their initial decision to develop an operation in the area. It further strengthens Ireland’s Life Sciences capability in the North East and builds on a series of new IDA projects announced for Dundalk and elsewhere in County Louth over recent times. This exciting new facility is a further example of the success of our commitment under the Regional Action Plans for Jobs to provide quality jobs in regional locations.”
“This further investment in Almac’s European Campus in Dundalk is a very positive development for the company and the North East region,” added Martin Shanahan, CEO, IDA Ireland. “The Irish facility plays a strategically important role within Almac’s global footprint. Companies continue to choose Ireland as a location which provides certainty of access to the European Union in the long-term post Brexit.”