WORLD WIDE REGULATORY APPROVALS
Patients all over the world trust medicines made by EirGen

Approvals

Achieving and retaining international regulatory approvals are essential for a pharmaceutical company with global commercial operations. EirGen’s supply chain consistently achieves the highest possible international regulatory standards, providing total confidence to industry partners, collaborators and healthcare buyers.

Integrity is highly valued by EirGen; we believe that our honesty and transparency gives our patients and customers trust in the quality of our products.

At EirGen, our R&D and commercial high containment facilities are continually audited and approved by the most stringent international regulatory authorities, including the US FDA and HPRA, which grants approval across all EU and many non-EU territories. EirGen is also approved by the Japanese PMDA and Saudi-FDA.

From our base in Ireland, we export specialty medicines to over fifty countries all around the world including the USA, UK, Canada, Japan, France, Germany and Australia.