Your Premier EU-Based Partner for High-Potency OSD & Softgel Excellence
Based in Waterford, Ireland, Eirgen Pharma provides a secure, EMA-certified foundation for the development and commercial supply of complex medicines. With 20+ years of technical expertise and a newly expanded HPRA-approved facility, we offer European innovators a reliable path from concept to commercial scale.
Why Eirgen Pharma for Europe?
Sovereign Supply Chains
Mitigate geopolitical and logistics risks by partnering with an EU-based manufacturer that simplifies intra-European distribution. Your inventory remains within the EU trade zone, ensuring predictable lead times and lower carbon footprints.
Zero-Gap Tech Transfer
Geographically proximate partnerships allow for real-time, on-site collaboration. Our Waterford team acts as a localized extensions of your own R&D, ensuring that critical process knowledge is transferred without the degradation often seen in intercontinental handoffs.
Scale Without Friction
Our expansion in Waterford, provides 500 million units of annual capacity, ensuring your growth is never capped by infrastructure limits.
Regulatory Familiarity & Speed
Our deep-rooted relationship with the HPRA and EMA means we operate with a "European-first" mindset. We anticipate regional regulatory shifts before they impact your production, providing a buffer against compliance-related downtime.
Aligned with Europe's Leading Pharma Hubs
Eirgen Pharma operates within the same regulatory, quality, and operational framework that defines Europe's leading pharmaceutical hubs across Germany, France, Italy, Spain, and the United Kingdom. From our Irish manufacturing site, we provide secure, centralized access to these core European markets, supporting clinical and commercial supply through a single inspection-ready European footprint.
Our Waterford site is designed to meet regualtory expectations applied across the EU5, ensuring consistent alignment with EMA, HPRA, and MHRA requirements while supporting global market access. This enables partners to supply Europe efficiently, without the operational complexity and risk associated with managing multiple manufacturing sites across fragmented jurisdictions.
As an OPKO Health subsidiary, Eirgen combines the technical agility of a specialist CDMO with the financial strength and governance model characteristic of large EU5-Based pharmaceutical organizations. This balance supports long-term investment, supply continuity, and regulatory confidence. For companies seeking a reliable European manufacturing base aligned with EMA standards, Eirgen offers a controlled, scalable supply chain delivering continuity, compliance, and confidence across Europe's most important pharmaceutical markets.
Our Capabilities
Specialist High-Potency OSD
We provide a secure, contained environment for the production of highly potent compounds. Our facilities feature advanced isolator technology, automated air handling, and stringent room pressure cascades, ensuring complete cross-contamination protection and safety for both your product and the operating environment.​
​
Leading Softgel Technology
​We offer a unique competitive advantage as Ireland's exclusive softgel producer and a premier provider within the EU. By mastering complex fill-formulations, we enhance the bioavailability and stability of poorly soluble molecules.
Our specialized team manages the entire process - from gelatin chemistry and encapsulation to precise drying parameter - ensuring your drug deliver peak performance.
​
Technical Continuity
We eliminate the "black box" approach to manufacturing. Our team of 50+ onsite scientists acts as an extension of your own R&D department. ​
By embedding our Quality by Design (QbD) principles from the onset, we ensure that process parameter are locked, validated, and perfectly preserved as your project transitions from pilot batches to full-scale commercial production.
​
"Eirgen’s depth of knowledge, thoroughness, and quality mindset were evident at every stage of engagement. The level of detail and transparency provided assurance that our testing and quality expectations would be fully supported."
​
A. Schneider, Director of Quality
Where Confidence Matters Most
With more than two decades of operational excellence and a proven track record of zero FDA 483 observations, Eirgen Pharma provides the regulatory assurance and financial stability required to operate successfully within the European market. Our newly appointed Operational Excellence (OpEx) team delivers the technical governance that underpins performance across our Waterford campus, ensuring processes are robust, controlled, and designed for sustained commercial supply.
Process improvement is managed as a structured, lifecycle-based discipline rather than a reactive intervention. This data-led operating model supports Eirgen's Right-First-Time (RFT) delivery philosophy, strengthening process reliability, shortening cycle times, and enabling efficient, low-risk technology transfer.
As an OPKO Health subsidiary, we combine the technical agility of a specialist CDMO with the strength and governance of a global organization. For our partners, this translates into a controlled, scalable, and inspection-ready commercial supply chain - supported by a quality-first culture that extends beyond compliance to a transparency-driven partnership approach. Real-time visibility, technical rigor, and regulatory discipline provide the confidence required to protect both product pipelines and patient safety over the long term.