Suppliers / CU Chemie Uetikon

CU Chemie Uetikon

Germany Updated 9 July 2026

CU Chemie Uetikon is an API manufacturer based in Germany. It holds 5 active US drug master files and 3 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 12 November 2021 as VAI.

5
active US DMFs
3
valid CEPs
2
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

  • 12 November 2021 VAI US FDA
  • 20 April 2018 VAI US FDA
  • 21 April 2016 VAI US FDA
  • 16 May 2013 NAI US FDA
  • 1 April 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Germany, Germany 3002806757
Lahr, Germany Not on file

What they file, and where

Molecule Regulators Docs
Esketamine EDQM, US FDA 2
Ketamine EDQM, US FDA 2
Methimazole EDQM, US FDA 2
Dalfampridine US FDA 1
Terazosin US FDA 1

Also appears on these molecule pages

Dalfampridine API Esketamine API Ketamine API Methimazole API Terazosin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 26

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Open risk flags

  • The most recent inspection outcome was VAI, on 12 November 2021.

Sources on this page

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