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

Questions about Croda International

Does Croda International hold a US DMF or a CEP?
Croda International holds 2 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 Croda International FDA-registered?
2 sites operated by Croda International carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Croda International's last inspection go?
The most recent inspection on record closed on 9 October 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Croda International manufacture?
3 registered sites are on record, in Germany and United Kingdom (Nettetal and United Kingdom among others). Every site is listed on this page with the register it came from.
What does Croda International make?
3 molecules are on record against Croda International, including Omega-3-Acid Ethyl Esters, Omega-3 Fatty Acids and Polysorbate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Croda International's GMP?
Current GMP certificates are on record from ZLG (DE) and US FDA. 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.

Comparing suppliers?

Choose your molecules and target markets. Croda International comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

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

Comparable suppliers

KinOmega Biopharm shares 1 molecule Kd Pharma Bexbach shares 1 molecule Shandong Yuwang Pharmaceutical shares 1 molecule Chemport shares 1 molecule Epax Norway shares 1 molecule

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
EudraGMDP and national regulators
GMP certificates