Suppliers / Fournier Laboratories Ireland

Fournier Laboratories Ireland

Ireland 3 duplicate records merged Updated 9 July 2026

Fournier Laboratories Ireland is a finished-dose manufacturer based in Ireland. It appears in 5 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), INVIMA (CO) and EMA. Its GMP standing is certified by MFDS (Korea), EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 25 November 2022 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
5
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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 November 2022 VAI US FDA
  • 23 November 2018 VAI US FDA
  • 14 December 2017 NAI US FDA
  • 26 September 2014 VAI US FDA
  • 20 October 2011 NAI US FDA
  • 6 March 2009 NAI US FDA

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

Registered plants

Site FDA FEI
CORK, Ireland Not on file
Ireland, Ireland 3004134577

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 3 None
INVIMA (CO) 1 None
EMA 1 2
MFDS (Korea) None 2
ANVISA (Brazil) None 1

Questions about Fournier Laboratories Ireland

Does Fournier Laboratories Ireland hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Fournier Laboratories Ireland. It does have 5 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Fournier Laboratories Ireland FDA-registered?
One site operated by Fournier Laboratories Ireland 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 Fournier Laboratories Ireland's last inspection go?
The most recent inspection on record closed on 25 November 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Fournier Laboratories Ireland manufacture?
2 registered sites are on record, in Ireland (Cork and Ireland). Every site is listed on this page with the register it came from.
Which regulators recognise Fournier Laboratories Ireland's GMP?
Current GMP certificates are on record from MFDS (Korea), EMA and ANVISA (Brazil). 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 VAI, on 25 November 2022.

Comparable suppliers

Abbvie Ireland Nl also in Ireland Amgen Technology (Ireland) Unlimited also in Ireland Chanelle Pharmaceuticals Manufacturing 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