Suppliers / Croda International

Croda International

United Kingdom Updated 9 July 2026

Croda International is an API manufacturer based in United Kingdom. It holds 2 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 9 October 2024 as VAI.

2
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 9 October 2024 VAI US FDA
  • 13 February 2020 VAI US FDA
  • 25 September 2019 VAI US FDA
  • 16 September 2016 VAI US FDA
  • 13 November 2014 NAI US FDA
  • 29 September 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Nettetal, Germany Not on file
United Kingdom, United Kingdom 3004214492
United Kingdom, United Kingdom 3004322377

What they file, and where

Molecule Regulators Docs
Omega-3-Acid Ethyl Esters US FDA 2
Omega-3 Fatty Acids SFDA (Saudi Arabia) 1
Polysorbate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Omega-3-Acid Ethyl Esters API Omega-3 Fatty Acids API

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 1 None
ZLG (DE) None 2
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 9 October 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates