Is Gentium S.r.L FDA approved?

Gentium S.r.L holds 1 FDA-registered establishment in Italy. 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 Gentium S.r.L's drugs manufactured?

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

Gentium S.r.L

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: Italy

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Gentium S.r.L	Piazza XX Settembre, 2, Villa Guardia, CO 22079, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture	3003744181432729114

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Common questions

Is Gentium S.r.L FDA approved?: Gentium S.r.L holds 1 FDA-registered establishment in Italy. 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 Gentium S.r.L's drugs manufactured?: The FDA register lists Villa Guardia. Registered operations: analytical testing, 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.