Syntese A/S
Denmark Updated 9 July 2026
Syntese A/S is an API manufacturer based in Denmark. It holds one active US drug master file and one valid CEP. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 12 May 2023 as VAI.
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
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 12 May 2023 VAI US FDA
- 17 June 2016 VAI US FDA
- 20 March 2014 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Denmark, Denmark | 3005574971 |
| Hvidovre, Denmark | Not on file |
What they file, and where
| Molecule | Regulators | Docs |
| Mesalazine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 12 May 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates