Suppliers / Sa Ajinomoto Omnichem

Sa Ajinomoto Omnichem

Belgium Updated 9 July 2026

The public registers hold a second record for Sa Ajinomoto Omnichem. The fuller profile, with 34 active US DMFs and 33 valid CEPs, is at Ajinomoto. Figures on this page cover only this record.

Sa Ajinomoto Omnichem is an API manufacturer based in Belgium. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its most recent recorded inspection, by US FDA, closed on 16 December 2022 as VAI.

2
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 16 December 2022 VAI US FDA
  • 16 March 2022 VAI US FDA
  • 29 June 2018 VAI US FDA
  • 22 June 2018 VAI US FDA
  • 20 June 2014 VAI US FDA
  • 24 January 2014 NAI US FDA
  • 10 November 2011 NAI US FDA
  • 4 December 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Belgium, Belgium 3003677791
Belgium, Belgium 3002807802

What they file, and where

Molecule Regulators Docs
Miconazole US FDA 1
Prazosin US FDA 1

Also appears on these molecule pages

Miconazole API Prazosin API

Questions about Sa Ajinomoto Omnichem

Does Sa Ajinomoto Omnichem hold a US DMF or a CEP?
Sa Ajinomoto Omnichem holds 2 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 Sa Ajinomoto Omnichem FDA-registered?
2 sites operated by Sa Ajinomoto Omnichem 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 Sa Ajinomoto Omnichem's last inspection go?
The most recent inspection on record closed on 16 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Sa Ajinomoto Omnichem manufacture?
2 registered sites are on record, in Belgium (Belgium among others). Every site is listed on this page with the register it came from.
What does Sa Ajinomoto Omnichem make?
2 molecules are on record against Sa Ajinomoto Omnichem, including Miconazole and Prazosin. Each links through to that molecule's full manufacturer list.

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 16 December 2022.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability