Suppliers / Sigma-Aldrich Ireland

Sigma-Aldrich Ireland

Ireland Updated 9 July 2026

Sigma-Aldrich Ireland is an API manufacturer based in Ireland. It holds 7 active US drug master files across a filed portfolio of 7 molecules. Its most recent recorded inspection, by US FDA, closed on 26 August 2022 as VAI.

7
active US DMFs
0
valid CEPs
1
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 26 August 2022 VAI US FDA
  • 12 October 2018 VAI US FDA
  • 19 February 2016 NAI US FDA
  • 2 November 2012 NAI US FDA
  • 12 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
Ireland, Ireland 3002807302

What they file, and where

Molecule Regulators Docs
Benzyl Alcohol US FDA 1
Brompheniramine US FDA 1
Clomipramine US FDA 1
Doxylamine US FDA 1
Ethanol US FDA 1
Nortriptyline US FDA 1
Sodium Benzoate US FDA 1

Also appears on these molecule pages

Clomipramine API Doxylamine API Nortriptyline API

Questions about Sigma-Aldrich Ireland

Does Sigma-Aldrich Ireland hold a US DMF or a CEP?
Sigma-Aldrich Ireland holds 7 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Sigma-Aldrich Ireland FDA-registered?
One site operated by Sigma-Aldrich 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 Sigma-Aldrich Ireland's last inspection go?
The most recent inspection on record closed on 26 August 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Sigma-Aldrich Ireland manufacture?
1 registered site is on record, in Ireland (Ireland). Every site is listed on this page with the register it came from.
What does Sigma-Aldrich Ireland make?
7 molecules are on record against Sigma-Aldrich Ireland, including Benzyl Alcohol, Brompheniramine, Clomipramine and Doxylamine. Each links through to that molecule's full manufacturer list.

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 26 August 2022.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability