Suppliers / Amgen Technology (Ireland) Unlimited
Amgen Technology (Ireland) Unlimited
Ireland Updated 9 July 2026
Amgen Technology (Ireland) Unlimited is a finished-dose manufacturer based in Ireland. It appears in 21 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with MPA (SE), EDE (AE) and BFARM (DE). Its GMP standing is certified by EMA, ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 September 2023 as NAI.
4
registered plants
1 with an FDA FEI number
21
filings
across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 13 September 2023 NAI US FDA
- 28 July 2023 VAI US FDA
- 26 October 2018 VAI US FDA
- 20 September 2018 NAI US FDA
- 22 September 2017 VAI US FDA
- 22 March 2013 VAI US FDA
- 29 October 2009 VAI US FDA
- 3 June 2009 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Dublin, United Arab Emirates | Not on file |
| DUBLIN, Ireland | Not on file |
| Co. Dublin, Ireland | Not on file |
| Ireland, Ireland | 3002808497 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| MPA (SE) | 10 | None |
| EDE (AE) | 5 | None |
| BFARM (DE) | 4 | None |
| ARCSA (EC) | 1 | None |
| INVIMA (CO) | 1 | None |
| EMA | None | 2 |
| ANVISA (Brazil) | None | 1 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 13 September 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates