Suppliers / Sigma-Aldrich Production

Sigma-Aldrich Production

Switzerland Updated 9 July 2026

Sigma-Aldrich Production is an API manufacturer based in Switzerland. It holds one active US drug master file across a filed portfolio of 2 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 22 September 2023 as NAI.

1
active US DMFs
0
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
3 of 3 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

  • 22 September 2023 NAI US FDA
  • 2 September 2016 NAI US FDA
  • 26 July 2012 VAI 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 3005258198
Buchs Sg, Switzerland Not on file

What they file, and where

Molecule Regulators Docs
Dimethyl SFDA (Saudi Arabia) 1
Mebrofenin US FDA 1

Also appears on these molecule pages

Dimethyl API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
US FDA None 1

Questions about Sigma-Aldrich Production

Does Sigma-Aldrich Production hold a US DMF or a CEP?
Sigma-Aldrich Production holds 1 active US drug master file. 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 Sigma-Aldrich Production FDA-registered?
One site operated by Sigma-Aldrich Production 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 Sigma-Aldrich Production's last inspection go?
The most recent inspection on record closed on 22 September 2023 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Sigma-Aldrich Production manufacture?
2 registered sites are on record, in Switzerland (Switzerland and Buchs Sg). Every site is listed on this page with the register it came from.
What does Sigma-Aldrich Production make?
2 molecules are on record against Sigma-Aldrich Production, including Dimethyl and Mebrofenin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sigma-Aldrich Production's GMP?
Current GMP certificates are on record from 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 22 September 2023.

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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