Is ALFASIGMA SPA FDA approved?

ALFASIGMA SPA holds 2 FDA-registered establishments 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 ALFASIGMA SPA's drugs manufactured?

The FDA register lists ALANNO; Pomezia. Registered operations: finished drug manufacture.

What drugs does ALFASIGMA SPA make?

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

ALFASIGMA SPA

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

Request a quote Claim this profile

Registered sites: 2
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: Italy

Authorisation

Registered operations

Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ALFASIGMA SPA	VIA ENRICO FERMI 1, ALANNO, PE 65020, Italy (ITA)	Finished drug manufacture	3003911081438537978
ALFASIGMA SPA	Via Pontina Km 30,400, Pomezia, Rome 00071, Italy (ITA)	Finished drug manufacture	3002808171438538098

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Rifaximin	tablet	70799-000DRUG FOR FURTHER PROCESSING

Compare

Comparable companies in Italy

Novo Nordisk Production Belgium SA2 sites · 24 NDC
Indena SpA2 sites · 15 NDC
Italfarmaco S.A.2 sites · 15 NDC
Doppel Farmaceutici S.r.l.2 sites · 10 NDC
Bioindustria Laboratorio Italiano Medicinali S.p.A.2 sites · 0 NDC
Cit Co., Ltd.2 sites · 0 NDC
FIS FABBRICA ITALIANA SINTETICI SPA3 sites · 128 NDC
GUNA-Spa1 site · 83 NDC
BSP Pharmaceuticals SpA1 site · 40 NDC
Kedrion Biopharma Inc.3 sites · 28 NDC

Enquiry

Common questions

Is ALFASIGMA SPA FDA approved?: ALFASIGMA SPA holds 2 FDA-registered establishments 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 ALFASIGMA SPA's drugs manufactured?: The FDA register lists ALANNO; Pomezia. Registered operations: finished drug manufacture.
What drugs does ALFASIGMA SPA make?: 1 product is listed under ALFASIGMA SPA in the openFDA NDC Directory, most often as tablet. 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.