Suppliers / Syntese A/S

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.

1
active US DMFs
1
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
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

Mesalamine API Mesalazine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Syntese A/S

Does Syntese A/S hold a US DMF or a CEP?
Syntese A/S holds 1 active US drug master file and 1 valid CEP. 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 Syntese A/S FDA-registered?
One site operated by Syntese A/S 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 Syntese A/S's last inspection go?
The most recent inspection on record closed on 12 May 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Syntese A/S manufacture?
2 registered sites are on record, in Denmark (Denmark and Hvidovre). Every site is listed on this page with the register it came from.
What does Syntese A/S make?
1 molecule is on record against Syntese A/S, including Mesalazine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Syntese A/S's GMP?
Current GMP certificates are on record from 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 VAI, on 12 May 2023.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates