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

Questions about CU Chemie Uetikon

Does CU Chemie Uetikon hold a US DMF or a CEP?
CU Chemie Uetikon holds 5 active US drug master files and 3 valid CEPs. 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 CU Chemie Uetikon FDA-registered?
One site operated by CU Chemie Uetikon 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 CU Chemie Uetikon's last inspection go?
The most recent inspection on record closed on 12 November 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does CU Chemie Uetikon manufacture?
2 registered sites are on record, in Germany (Germany and Lahr). Every site is listed on this page with the register it came from.
What does CU Chemie Uetikon make?
5 molecules are on record against CU Chemie Uetikon, including Esketamine, Ketamine, Methimazole and Dalfampridine. Each links through to that molecule's full manufacturer list.
Which regulators recognise CU Chemie Uetikon's GMP?
Current GMP certificates are on record from ZLG (DE). 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.

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Open risk flags

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

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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
EudraGMDP and national regulators
GMP certificates