Is S.M. FARMACEUTICI SRL FDA approved?

S.M. FARMACEUTICI SRL 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 S.M. FARMACEUTICI SRL's drugs manufactured?

The FDA register lists Tito. Registered operations: analytical testing, finished drug manufacture.

S.M. FARMACEUTICI SRL

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 testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
S.M. FARMACEUTICI SRL	Via Zona Industriale SNC, Tito, Potenza 85050, Italy (ITA)	Analytical testing, Finished drug manufacture	3008409127430188286

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Common questions

Is S.M. FARMACEUTICI SRL FDA approved?: S.M. FARMACEUTICI SRL 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 S.M. FARMACEUTICI SRL's drugs manufactured?: The FDA register lists Tito. Registered operations: analytical testing, 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.