Suppliers / Pfizer Ireland Pharmaceuticals Unlimited

Pfizer Ireland Pharmaceuticals Unlimited

Ireland Updated 9 July 2026

Pfizer Ireland Pharmaceuticals Unlimited is a finished-dose manufacturer based in Ireland. It appears in 34 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), EMA and ARCSA (EC). Its GMP standing is certified by EMA, ANVISA (Brazil) and EAEU_EEC, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 25 October 2024 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 3 with an FDA FEI number
34
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 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

  • 25 October 2024 VAI US FDA
  • 15 December 2023 VAI US FDA
  • 23 September 2022 VAI US FDA
  • 12 November 2019 VAI US FDA
  • 27 September 2019 VAI US FDA
  • 9 November 2018 VAI US FDA
  • 18 September 2018 VAI US FDA
  • 17 August 2018 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
NEWBRIDGE, Ireland Not on file
Ireland, Ireland 3006785053
Dublin 22, Ireland Not on file
Ringaskiddy, Ireland Not on file
Ireland, Ireland 3002807852
Ireland, Ireland 3004145594

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 16 None
EMA 5 6
ARCSA (EC) 4 None
INVIMA (CO) 4 None
FAMHP (BE) 2 None
MPA (SE) 2 None
ANVISA (Brazil) None 5
EAEU_EEC None 3
US FDA None 2

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Open risk flags

  • The most recent inspection outcome was VAI, on 25 October 2024.

Sources on this page

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