Our Manufacturing
Campus
World-Class CDMO & CMO Facilities for High Potency Oral Solid Dose Manufacturing
At Eirgen Pharma, our pharmaceutical manufacturing facilities in Waterford, Ireland, are purpose-built to meet the evolving needs of high-potency drug development and commercialization. As a specialist CDMO with a global client base, we offer world-class capabilities in formulation, scale-up, and commercial manufacturing of highly potent oral solid dose (OSD) medicines - all underpinned by robust regulatory compliance, advanced containment technologies, and an uncompromising commitment to quality.
Our Facility
Eirgen's facilities are based in Waterford, Ireland - a location that offers strategic access to both European and US markets. Our campus spans 40,000ft² of dedicated manufacturing space, with an additional 3,500m² high-containment expansion underway, set to be fully operational by late 2025. This expansion is designed to accommodate increased demand, enhance flexibility, and future-proof our high-potency manufacturing capabilities.
Manufacturing Capabilities That Grow With You
Our facilities are designed from the ground up for high-potency and non-potent oral solid dose production, featuring ISO 14644 Class 8 cleanrooms, single-pass air systems with HEPA filtration, and cascading pressure zones to maintain containment integrity. Humidity-controlled suites - maintained below 30% RH - support the safe handling of sensitive and potent materials, while downflow booths, LEVs, isolator technology, and OEB 4 containment solutions ensure the highest levels of operator and product safety.
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Every element - from full body PPE protocols to real-time environmental monitoring - reflects our dedication to safe, compliant, and efficient pharmaceutical manufacturing.
40,000ft dedicated Hi-Potency Facility
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Low Humidity capability (<30%RH)
ISO 14644 Class 8 Clean-room Standard
Full body Air-Suit Capability
Single-pass double HEPA filtered air
Fully-equipped Analytical Labs
Fully Segregated Processing Rooms
Equipment to support Oral Solid Dose Manufacture & Packaging
Whether you're scaling up from clinical trial supply or moving into commercial production, Eirgen provides full-spectrum GMP-compliant manufacturing for a wide range of dosage forms, including film-coated tablets, hard-shell capsules, and softgel capsules.
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We specialize in the handling if highly potent APIs (HPAPI's), including cytotoxic, teratogenic, and genotoxic compounds - and our experienced team manages everything from tech transfer and process validation to pharmaceutical packaging and serialization with precision and care.
Integrated R&D and Analytical Services
Innovation lies at the heart of our operations. Our onsite research and development laboratories are home to over 50 scientists working across formulation, analytical development, and regulatory support. We offer end-to-end capabilities, including;
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Formulation Development (immediate- and extended-release)
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Analytical method development and validation
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ICH stability testing
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CMC documentation and regulatory filing support
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This seamless integration between R&D and manufacturing ensures speed, efficiency, and quality throughout your product's lifecycle.
Looking to the future, Eirgen's ​3,500m² facility expansion is a significant step forward. Scheduled for completing in Q3 2025, the project includes the addition of high-containment manufacturing suites, enhanced blending, granulation, and tableting capabilities, and increased flexibility for both small and large batch sizes.
This new facility is designed to accommodate accelerated tech transfers, complex formulation requirements, and the next generation of high-potency therapies.
Expanding Capacity, Accelerating Possibility
Why Partner With Eirgen?
As a trusted CDMO partner, we combine scientific excellence with manufacturing expertise to deliver high-quality outcomes - consistently, safely, and on time. Our partners choose us for:
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Our specialized focus on high-potency oral solid dose manufacturing
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Fully integrated clinical-to-commercial development support
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Advanced containment technology and cleanroom infrastructure
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Regulatory excellence across FDA, EMA, and global standards
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Strategic EU-based location with global supply chain connectivity