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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 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

Questions about Amgen Technology (Ireland) Unlimited

Does Amgen Technology (Ireland) Unlimited hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Amgen Technology (Ireland) Unlimited. It does have 21 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Amgen Technology (Ireland) Unlimited FDA-registered?
One site operated by Amgen Technology (Ireland) Unlimited carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Amgen Technology (Ireland) Unlimited's last inspection go?
The most recent inspection on record closed on 13 September 2023 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Amgen Technology (Ireland) Unlimited manufacture?
4 registered sites are on record, in United Arab Emirates and Ireland (Dublin, Dublin and Co. Dublin among others). Every site is listed on this page with the register it came from.
Which regulators recognise Amgen Technology (Ireland) Unlimited's GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was NAI, on 13 September 2023.

Comparable suppliers

Abbvie Ireland Nl also in Ireland Chanelle Pharmaceuticals Manufacturing also in Ireland Fournier Laboratories Ireland also in Ireland Haleon Ireland Dungarvan also in Ireland Helsinn Birex Pharmaceuticals also in Ireland

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates