Suppliers / Dottikon Exclusive Synthesis

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
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
4 of 4 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

  • 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

Olaparib API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2

Questions about Dottikon Exclusive Synthesis

Does Dottikon Exclusive Synthesis hold a US DMF or a CEP?
Dottikon Exclusive Synthesis 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 Dottikon Exclusive Synthesis FDA-registered?
One site operated by Dottikon Exclusive Synthesis 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 Dottikon Exclusive Synthesis'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). 4 inspections are on file.
Where does Dottikon Exclusive Synthesis manufacture?
2 registered sites are on record, in Switzerland (Switzerland and Dottikon). Every site is listed on this page with the register it came from.
What does Dottikon Exclusive Synthesis make?
3 molecules are on record against Dottikon Exclusive Synthesis, including Isosorbide Mononitrate, Olaparib and Olsalazine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Dottikon Exclusive Synthesis's GMP?
Current GMP certificates are on record from EMA. 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 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
EudraGMDP and national regulators
GMP certificates