Dottikon Exclusive Synthesis
Switzerland Updated 9 July 2026
Dottikon Exclusive Synthesis is an API manufacturer based in Switzerland. It holds 2 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 16 December 2022 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
4 of 4 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
- 16 December 2022 VAI US FDA
- 14 July 2017 VAI US FDA
- 11 September 2015 VAI US FDA
- 28 September 2012 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 | 3002806909 |
| Dottikon, Switzerland | Not on file |
What they file, and where
| Molecule | Regulators | Docs |
| Isosorbide Mononitrate | US FDA | 1 |
| Olaparib | SFDA (Saudi Arabia) | 1 |
| Olsalazine | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| EMA | None | 2 |
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Open risk flags
- The most recent inspection outcome was VAI, on 16 December 2022.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates