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

Questions about Sk Biotek Ireland

Is Sk Biotek Ireland FDA-registered?
One site operated by Sk Biotek 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 Sk Biotek Ireland's last inspection go?
The most recent inspection on record closed on 13 May 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Sk Biotek 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 Sk Biotek Ireland make?
1 molecule is on record against Sk Biotek Ireland, including Dapagliflozin Propanediol. 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 13 May 2022.

Comparable suppliers

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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