Eirgen Pharma has received full approval from the Health Products Regulatory Authority for its newly constructed manufacturing facility at the IDA Waterford Business Park, confirming the site meets all Good Manufacturing Practice requirements and is authorised to develop and manufacture both investigational medicinal products and commercial pharmaceutical products.

According to Waterford Chamber, the certification marks a significant expansion of the Waterford-based contract development and manufacturing organisation's operational footprint, adding substantial capacity to support clinical and commercial manufacturing, high-potency handling and containment technologies, innovative formulation development, and scalable production for global markets.

Clodagh Dunne, Head of Quality and Qualified Person at Eirgen Pharma, said: "This is a landmark moment for Eirgen Pharma. 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."

The newly approved facility is designed to support a wider range of customer partnerships, including the development of high-potency, niche, and complex products. It enables seamless progression from early-stage development through to commercial supply, reinforcing the company's reputation for regulatory excellence.

The investment further strengthens Ireland's position as a global hub for life sciences and supports the continued growth of high-value pharmaceutical production in the Waterford region.

As demand for high-quality pharmaceutical development and manufacturing continues to rise globally, the expanded facility positions Eirgen Pharma to respond rapidly to new opportunities in both human and animal health therapeutics.

Explore the full announcement to learn more about Eirgen Pharma's new facility and expanded capabilities.