Suppliers / Pfizer Ireland Pharmaceuticals

Pfizer Ireland Pharmaceuticals

Ireland Updated 9 July 2026

Pfizer Ireland Pharmaceuticals is an API and finished-dose manufacturer based in Ireland. It appears in 42 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), ARCSA (EC) and AIFA (IT). Its GMP standing is certified by EAEU_EEC and NAFDAC (NG).

0
active US DMFs
0
valid CEPs
0
registered plants
42
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

What they file, and where

Molecule Regulators Docs
Axitinib SFDA (Saudi Arabia) 1
Dacomitinib SFDA (Saudi Arabia) 1
Palbociclib SFDA (Saudi Arabia) 1
Tafamidis SFDA (Saudi Arabia) 1
Tofacitinib SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Axitinib API Ceftazidime finished dose Palbociclib API Tafamidis API Tofacitinib API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 21 None
ARCSA (EC) 5 None
AIFA (IT) 4 None
INVIMA (CO) 2 None
ANPP (DZ) 2 None
BOMRA (BW) 2 None
EAEU_EEC None 3
NAFDAC (NG) None 1

Questions about Pfizer Ireland Pharmaceuticals

Does Pfizer Ireland Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pfizer Ireland Pharmaceuticals. It does have 42 filings with 10 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
What does Pfizer Ireland Pharmaceuticals make?
5 molecules are on record against Pfizer Ireland Pharmaceuticals, including Axitinib, Dacomitinib, Palbociclib and Tafamidis. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pfizer Ireland Pharmaceuticals's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union) and NAFDAC (NG). 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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Sources on this page

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