Suppliers / Ipsen Manufacturing Ireland

Ipsen Manufacturing Ireland

Ireland Updated 9 July 2026

Ipsen Manufacturing Ireland is an API manufacturer based in Ireland. Its GMP standing is certified by EMA. 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
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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
  • 14 June 2018 NAI US FDA
  • 8 August 2014 NAI US FDA

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

Registered plants

Site FDA FEI
Ireland, Ireland 3002807392
Dublin 15, Ireland Not on file

What they file, and where

Molecule Regulators Docs
Lanreotide SFDA (Saudi Arabia) 1
Triptorelin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Lanreotide API Triptorelin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Ipsen Manufacturing Ireland

Is Ipsen Manufacturing Ireland FDA-registered?
One site operated by Ipsen Manufacturing 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 Ipsen Manufacturing 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). 3 inspections are on file.
Where does Ipsen Manufacturing Ireland manufacture?
2 registered sites are on record, in Ireland (Ireland and Dublin 15). Every site is listed on this page with the register it came from.
What does Ipsen Manufacturing Ireland make?
2 molecules are on record against Ipsen Manufacturing Ireland, including Lanreotide and Triptorelin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ipsen Manufacturing Ireland's GMP?
Current GMP certificates are on record from EMA. 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.

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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