MANUFACTURING

Our manufacturing and packaging facilities are located in Galway in the west of Ireland. They are US Food & Drug Administration (FDA) and Irish Medicines Board (IMB) approved, as well as being ISO EN 13485 accredited by Amtac (manufacture and sale of medical devices), which allows use of the CE mark.

To meet ever-increasing production demands and the prospect of even greater growth in the future, we have recently completed a new, state-of-the-art sterile filling facility also located in County Galway. Its completion adds another 21,000 square feet of production space and almost doubles our total manufacturing capacity.

The new facility has substantially increased both our vial and syringe capacity. Based on the current mix of vial sizes, vial capacity is now at 5 million units per year, while our syringe capacity has increased from 1 million units to 3.5 million units per year. The new facility meets all international standards for sterile injectables.