Is GALENICA S.A. FDA approved?

GALENICA S.A. holds 1 FDA-registered establishment in Greece. 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 GALENICA S.A.'s drugs manufactured?

The FDA register lists Halkida. Registered operations: finished drug manufacture.

GALENICA S.A.

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: Greece

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
GALENICA FARMAKEFTIKI VIOMICHANIA ANONYMI ETAIREIARegistrant: GALENICA S.A.	3rd Km Old National Road Chalkida - Athens, Glifa, Halkida, Sterea Ellada and Evoia 34100, Greece (GRC)	Finished drug manufacture	3012189222506970191

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Common questions

Is GALENICA S.A. FDA approved?: GALENICA S.A. holds 1 FDA-registered establishment in Greece. 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 GALENICA S.A.'s drugs manufactured?: The FDA register lists Halkida. Registered operations: finished drug 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.