Suppliers / Carbogen Amcis

Carbogen Amcis

Switzerland 733 employees Updated 9 July 2026

Carbogen Amcis is an API and finished-dose manufacturer based in Switzerland. It holds 5 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by ANSM (FR), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 26 June 2024 as NAI.

5
active US DMFs
0
valid CEPs
8
registered plants 3 with an FDA FEI number
5
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 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

  • 26 June 2024 NAI US FDA
  • 21 June 2024 NAI US FDA
  • 16 December 2022 VAI US FDA
  • 8 September 2017 NAI US FDA
  • 22 October 2015 NAI US FDA
  • 20 October 2015 NAI US FDA
  • 14 March 2014 VAI US FDA
  • 29 September 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
Switzerland, Switzerland 3000998501
Switzerland, Switzerland 3005976586
Switzerland, Switzerland 3006999285
Hunzenschwil, Switzerland Not on file
Bubendorf, Switzerland Not on file
Aarau, Switzerland Not on file

2 further sites are on record.

What they file, and where

Molecule Regulators Docs
Cholesterol US FDA 2
Azacitidine SFDA (Saudi Arabia) 1
Bendamustine SFDA (Saudi Arabia) 1
Calcifediol US FDA 1
Calcitriol US FDA 1
Nepafenac US FDA 1
Ozanimod SFDA (Saudi Arabia) 1
Pomalidomide SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Azacitidine API Bendamustine API Brinzolamide finished dose Calcitriol API Nepafenac API Ozanimod API Pomalidomide API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 5 None
ANSM (FR) None 10
EMA None 6
US FDA None 2

Questions about Carbogen Amcis

Does Carbogen Amcis hold a US DMF or a CEP?
Carbogen Amcis holds 5 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 Carbogen Amcis FDA-registered?
3 sites operated by Carbogen Amcis 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 Carbogen Amcis's last inspection go?
The most recent inspection on record closed on 26 June 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Carbogen Amcis manufacture?
8 registered sites are on record, in Switzerland and France (Switzerland, Hunzenschwil and Bubendorf among others). Every site is listed on this page with the register it came from.
What does Carbogen Amcis make?
8 molecules are on record against Carbogen Amcis, including Cholesterol, Azacitidine, Bendamustine and Calcifediol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Carbogen Amcis's GMP?
Current GMP certificates are on record from ANSM (FR), EMA 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.

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Open risk flags

  • The most recent inspection outcome was NAI, on 26 June 2024.

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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