Eirgen Pharma is pleased to announce that its newly constructed manufacturing facility at the IDA Waterford Business Park has received full approval from the Health Products Regulatory Authority (HPRA).

This certification confirms that the facility meets all Good Manufacturing Practice (GMP) requirements, authorizing the site to develop and manufacture investigational medicinal products (IMPs) and commercial pharmaceutical products.

This approval represents a significant milestone in Eirgen Pharma’s strategic expansion and strengthens the company’s ongoing commitment to delivering high-quality, innovative healthcare solutions to patients worldwide.

A Major Investment in Ireland’s Life Sciences Landscape
The new facility — designed to support both current and future manufacturing needs — adds substantial capacity to Eirgen Pharma’s operational footprint. Equipped with advanced technologies and built to meet global regulatory standards, the site represents a major investment in the continued growth of pharmaceutical production within the Waterford region.

This development further reinforces Ireland’s position as a global hub for life sciences and reflects Eirgen Pharma’s long-standing commitment to contributing to the local economy, attracting high-value jobs, and supporting regional innovation.

Enhancing Capability, Quality, and Global Reach
With HPRA approval now secured, the facility is positioned to support a wider range of customer partnerships, including the development of high-potency, niche, and complex products. The newly approved site enhances Eirgen Pharma’s capacity across:

  • Clinical and commercial manufacturing
  • High-potency handling and containment technologies
  • Innovative formulation development
  • Scalable production for global markets
The approval also strengthens Eirgen Pharma’s integrated service offering, enabling seamless progression from early development through to commercial supply — and reinforcing the company’s reputation for efficiency, quality, and regulatory excellence.

A Milestone for the Future
“This is a landmark moment for Eirgen Pharma,” said Clodagh Dunne, Head of Quality & Qualified Person.

“The HPRA approval of our new facility represents years of planning, investment, and dedicated teamwork. This achievement not only expands our manufacturing capabilities but also deepens our commitment to advancing pharmaceutical innovation in Waterford and supporting patients across the world.”

Eirgen Pharma extends its appreciation to the internal teams, partners, and industry collaborators who supported the successful development, inspection, and approval of the new facility.

Supporting Growth, Innovation, and Global Partnerships
As demand for high-quality pharmaceutical development and manufacturing continues to rise globally, this expanded facility positions Eirgen Pharma to meet the evolving needs of international partners and respond rapidly to new opportunities in human and animal health therapeutics.

The company looks forward to leveraging this new capacity to advance its pipeline of projects, strengthen strategic alliances, and enhance its role as a trusted partner within the global life sciences community.