Ortec has announced that construction has begun on its European Headquarters, Manufacturing and Operations Centre in Newcastle West, Limerick.

Founded in 1980 and headquartered in Easley, South Carolina, Ortec offers custom materials used in medical devices, pharmaceuticals, and other health-related FDA/EMA regulated industries. Phase One of the project includes a 26,000ft2 dedicated cGMP manufacturing facility which will give Irish and European manufacturers a local option when looking to source new or existing process chemicals where quality and consistency are critical parameters.

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In addition to product synthesis, other facility capabilities include USP/EP generated water, a full-service analytical laboratory, and an ISO 8/Class 100,000 Clean Room. The site is intended to be ISO 13485 certified and will operate under FDA/EMA guidelines for production of pharmaceutical, combination, and medical device materials.

Ortec Site Manager Colm Maguire said: "Ortec has been offering its products and services solely from its base in South Carolina to its global customers. I am pleased and excited to announce that we have started construction of Ortec’s facility in Newcastle West. This facility, the first for us outside of North America will give European customers a contract manufacturing option which will be completed and available mid-2022."