A centre of excellence for research, development and commercialisation of High Potency Oral Solid Dose medicines
Our facility
Located in Waterford, Ireland, Eirgen Pharma operates state-of-the-art, globally-accredited manufacturing facilities specializing in high-potency drug production. Our advanced CDMO and CMO services support the development and commercialization of cytotoxic, genotoxic and moisture-sensitive drug products across multiple platforms.
Our latest 3,500m² expansion is set to be fully operational for commercial manufacturing by late 2025. This additional manufacturing space will enhance our high-containment manufacturing capabilities.
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
Our GMP-Compliant manufacturing suites support the manufacture of high-potency pharmaceutical products in multiple dosage forms, including film-coated tablets, softgel capsules, and hard-shell capsules (powder/liquid-filled). We specialize in oral solid dose (OSD) manufacturing for both small molecule APIs and highly potent active pharmaceutical ingredients (HPAPIs), ensuring regulatory compliance.
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The design of our suites incorporates single-pass, cascading negative air pressure systems leading to dedicated high-containment handling areas. These systems enhance occupational safety and mitigate risk of cross-contamination, aligning with EU-GMP and US-FDA containment standards.
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Our state-of-the-art containment technologies include performance-qualified, closed-loop isolators, downflow and powder containment booths, and local exhaust ventilation (LEV) systems, ensuring the highest level of operator protection and product integrity.
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Risk-dependent PPE (air suits, masks and so on) is used as a secondary control throughout processes.
R&D
Our dedicated pharmaceutical research and development centre is staffed by a highly skilled team with decades of industry experience.
The team performs cutting-edge research and development while consistently achieving the highest cGMP quality standards. It includes 53 Pharmaceutical Development professionals, including Formulators and Analytical Chemists, Regulatory Affairs, and Clinical Affairs.
Our Formulation and Analytical Chemists bring extensive experience in handling highly potent APIs (HPAPIs), teratogenic, cytotoxic, mutagenic and high bioaccumulation materials, with OELs as low as 20 ng/m3. Our team is resourced and experienced to deliver high-value oral solid dose (OSD) pharmaceuticals. Our capabilities in formulation and analytical development are strongly focused on applying this experience to multiple platforms, to develop innovative medicines, as well as standard generics in the high containment space.
Because Accuracy Matters
Precision is everything — to that end we have invested heavily in market-leading technology that guarantees a level of accuracy that is second to none.