Is Biofer, SpA FDA approved?

Biofer, SpA 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 Biofer, SpA's drugs manufactured?

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

What drugs does Biofer, SpA make?

2 products are listed under Biofer, SpA in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Biofer, SpA

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Biofer, SpA	Via Canina 2, Medolla, MO 41036, Italy (ITA)	Active ingredient (API) manufacture	3005593220434431946

Catalogue

Drug listings by form and route

2 active NDC listings: 2 bulk ingredient. By marketing category: BULK INGREDIENT 2.

Dosage form	NDCs
powder	2

Route	NDCs

Labeller name on the listing	NDCs
biofer, spa	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	HEPARIN SODIUM	powder	44498-002BULK INGREDIENT
-	Sodium Ferric Gluconate Complex	powder	44498-001BULK INGREDIENT

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Enquiry

Common questions

Is Biofer, SpA FDA approved?: Biofer, SpA 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 Biofer, SpA's drugs manufactured?: The FDA register lists Medolla. Registered operations: active ingredient (API) manufacture.
What drugs does Biofer, SpA make?: 2 products are listed under Biofer, SpA in the openFDA NDC Directory, most often as powder. 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.