Suppliers / Abbvie Ireland Nl

Abbvie Ireland Nl

Ireland Updated 9 July 2026

Abbvie Ireland Nl is an API and finished-dose manufacturer based in Ireland. It appears in 35 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EMA and EAEU_EEC. Its most recent recorded inspection, by US FDA, closed on 14 December 2022 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
35
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

  • 14 December 2022 VAI US FDA
  • 28 February 2020 VAI US FDA
  • 29 August 2019 NAI US FDA
  • 20 January 2017 NAI US FDA
  • 12 September 2014 NAI US FDA
  • 24 March 2011 NAI US FDA

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

Registered plants

Site FDA FEI
SLIGO, Ireland Not on file
Ireland, Ireland 3004364014

What they file, and where

Molecule Regulators Docs
Paricalcitol SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Paricalcitol API Upadacitinib finished dose Venetoclax finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 22 None
MINSA (CR) 10 None
INVIMA (CO) 3 None
EMA None 4
EAEU_EEC None 1

Questions about Abbvie Ireland Nl

Does Abbvie Ireland Nl hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Abbvie Ireland Nl. It does have 35 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Abbvie Ireland Nl FDA-registered?
One site operated by Abbvie Ireland Nl 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 Abbvie Ireland Nl's last inspection go?
The most recent inspection on record closed on 14 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Abbvie Ireland Nl manufacture?
2 registered sites are on record, in Ireland (Sligo and Ireland). Every site is listed on this page with the register it came from.
What does Abbvie Ireland Nl make?
1 molecule is on record against Abbvie Ireland Nl, including Paricalcitol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Abbvie Ireland Nl's GMP?
Current GMP certificates are on record from EMA and EEC (Eurasian Economic Union). 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 14 December 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