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 INVIMA (CO). 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
Ireland, Ireland 3002807852
Ireland, Ireland 3004145594
Ringaskiddy, Ireland Not on file

Filings and GMP by regulator

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

Questions about Pfizer Ireland Pharmaceuticals Unlimited

Does Pfizer Ireland Pharmaceuticals Unlimited hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pfizer Ireland Pharmaceuticals Unlimited. It does have 34 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Pfizer Ireland Pharmaceuticals Unlimited FDA-registered?
3 sites operated by Pfizer Ireland Pharmaceuticals Unlimited carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Pfizer Ireland Pharmaceuticals Unlimited's last inspection go?
The most recent inspection on record closed on 25 October 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Pfizer Ireland Pharmaceuticals Unlimited manufacture?
6 registered sites are on record, in Ireland (Newbridge, Ireland and Dublin 22 among others). Every site is listed on this page with the register it came from.
Which regulators recognise Pfizer Ireland Pharmaceuticals Unlimited's GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil), EEC (Eurasian Economic Union) 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.

Comparing suppliers?

Choose your molecules and target markets. Pfizer Ireland Pharmaceuticals Unlimited comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

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

Comparable suppliers

Abbvie Ireland Nl also in Ireland Amgen Technology (Ireland) Unlimited also in Ireland Chanelle Pharmaceuticals Manufacturing also in Ireland Fournier Laboratories Ireland also in Ireland Haleon Ireland Dungarvan 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