Is Syntese A/S FDA approved?

Syntese A/S holds 1 FDA-registered establishment in Denmark. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Syntese A/S's drugs manufactured?

The FDA register lists Hvidovre. Registered operations: analytical testing, active ingredient (API) manufacture, labelling.

What drugs does Syntese A/S make?

1 product is listed under Syntese A/S in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Syntese A/S

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: Denmark

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Syntese A/S	Industriholmen 13, Hvidovre, 2650, Denmark (DNK)	Analytical testing, Active ingredient (API) manufacture, Labelling	3005574971305104267

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Mesalamine	powder	24528-0003BULK INGREDIENT

Neighbours

Registered in the same town

Chr. Olesen Synthesis A/SHvidovre, DNK

Compare

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Fertin Pharma A/S1 site · 25 NDC
Pharmacosmos A/S1 site · 10 NDC
Chr. Olesen Synthesis A/S1 site · 1 NDC
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Zealand Pharma A/S2 sites · 0 NDC
Xellia Pharmaceuticals ApS3 sites · 50 NDC
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Novo Nordisk Inc.11 sites · 124 NDC

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Common questions

Is Syntese A/S FDA approved?: Syntese A/S holds 1 FDA-registered establishment in Denmark. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Syntese A/S's drugs manufactured?: The FDA register lists Hvidovre. Registered operations: analytical testing, active ingredient (API) manufacture, labelling.
What drugs does Syntese A/S make?: 1 product is listed under Syntese A/S in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.