Eirgen Pharma Ltd

Waterford, IrelandFEI 3007075468

Eirgen Pharma Ltd is a drug establishment in Waterford, Ireland, registered with the US FDA under FEI 3007075468. Its registered operations are: Analytical testing, Labelling, Drug manufacture, Packaging, Relabelling, Repackaging. 10 EU/UK GMP certificates are matched to this site, 6 inspected within the last three years.

Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology

Registered operations

Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.

Analytical testingLabellingDrug manufacturePackagingRelabellingRepackaging

GMP documents matched to this site (10)

DocumentAuthorityInspectionSource
CRN00HCH8/M01043/00001
GMP certificate
Competent authority of Ireland3 Jul 2026
within 3-year review window
EudraGMDP
CRN00HCH8/IMP00049/00001
GMP certificate
Competent authority of Ireland3 Jul 2026
within 3-year review window
EudraGMDP
CRN00HCH8/V12319/00001
GMP certificate
Competent authority of Ireland3 Jul 2026
within 3-year review window
EudraGMDP
36560/V12319
GMP certificate
Competent authority of Ireland22 Oct 2025
within 3-year review window
EudraGMDP
36560/IMP00049
GMP certificate
Competent authority of Ireland22 Oct 2025
within 3-year review window
EudraGMDP
36560/M01043
GMP certificate
Competent authority of Ireland22 Oct 2025
within 3-year review window
EudraGMDP
33757/IMP00049/00001
GMP certificate
Competent authority of Ireland13 Oct 2023
outside 3-year review window
EudraGMDP
33757/M1043/00001
GMP certificate
Competent authority of Ireland13 Oct 2023
outside 3-year review window
EudraGMDP
33757/V12319/00001
GMP certificate
Competent authority of Ireland13 Oct 2023
outside 3-year review window
EudraGMDP
33757/V12319/0001
GMP certificate
Competent authority of IRELAND13 Oct 2023
outside 3-year review window
EudraGMDP

A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.

What this page does not show

  • Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
  • Capacity, scale, price or current availability: no regulator publishes these.
  • FDA inspection classifications for this site, which are not yet linked.