Suppliers / ChemCon

ChemCon

Germany Updated 9 July 2026

ChemCon is an API manufacturer based in Germany. It holds 10 active US drug master files across a filed portfolio of 10 molecules. Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 8 September 2022 as VAI.

10
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 8 September 2022 VAI US FDA
  • 26 October 2018 NAI US FDA
  • 27 March 2014 NAI US FDA
  • 7 July 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
Freiburg, Germany Not on file
Freiburg Im Breisgau, Germany Not on file
Germany, Germany 3002553230
Baden-Wuerttemberg, Germany Not on file

What they file, and where

Molecule Regulators Docs
Arsenic Trioxide SFDA (Saudi Arabia), US FDA 2
Chromium US FDA 1
Copper US FDA 1
Iron US FDA 1
Methylene Blue US FDA 1
Molybdate US FDA 1
Nitroprusside US FDA 1
Selenious Acid US FDA 1
Sodium Selenite US FDA 1
Zinc Chloride US FDA 1

Also appears on these molecule pages

Anagrelide contract manufacturing Melphalan contract manufacturing Methylene Blue API Nicardipine contract manufacturing Selenious Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
ZLG (DE) None 68
EMA None 2

Questions about ChemCon

Does ChemCon hold a US DMF or a CEP?
ChemCon holds 10 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 ChemCon FDA-registered?
One site operated by ChemCon 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 ChemCon's last inspection go?
The most recent inspection on record closed on 8 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does ChemCon manufacture?
4 registered sites are on record, in Germany (Freiburg, Freiburg Im Breisgau and Germany among others). Every site is listed on this page with the register it came from.
What does ChemCon make?
10 molecules are on record against ChemCon, including Arsenic Trioxide, Chromium, Copper and Iron. Each links through to that molecule's full manufacturer list.
Which regulators recognise ChemCon's GMP?
Current GMP certificates are on record from ZLG (DE) and EMA. 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 8 September 2022.

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Sources on this page

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