Is UNA-Synth FDA approved?

UNA-Synth holds 1 FDA-registered establishment in Germany. 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 UNA-Synth's drugs manufactured?

The FDA register lists Kaltenkirchen. Registered operations: active ingredient (API) manufacture.

UNA-Synth

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
UNA-Synth GmbHRegistrant: UNA-Synth	Leibnizstr. 12, Kaltenkirchen, 24568, Germany (DEU)	Active ingredient (API) manufacture	3010471580312896803

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Common questions

Is UNA-Synth FDA approved?: UNA-Synth holds 1 FDA-registered establishment in Germany. 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 UNA-Synth's drugs manufactured?: The FDA register lists Kaltenkirchen. Registered operations: active ingredient (API) manufacture.

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.