Suppliers / Sk Biotek Ireland

Sk Biotek Ireland

Ireland Updated 9 July 2026

Sk Biotek Ireland is an API manufacturer based in Ireland. Its most recent recorded inspection, by US FDA, closed on 13 May 2022 as VAI.

0
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
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 13 May 2022 VAI US FDA
  • 5 April 2019 VAI US FDA
  • 3 November 2017 VAI US FDA
  • 25 February 2016 VAI US FDA
  • 20 September 2013 NAI US FDA
  • 12 May 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
Ireland, Ireland 3002806583

What they file, and where

Molecule Regulators Docs
Dapagliflozin Propanediol SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Dapagliflozin Propanediol API

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Open risk flags

  • The most recent inspection outcome was VAI, on 13 May 2022.

Sources on this page

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