Is Biosint S.p.A FDA approved?

Biosint S.p.A 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 Biosint S.p.A's drugs manufactured?

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

What drugs does Biosint S.p.A make?

1 product is listed under Biosint S.p.A 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.

Biosint S.p.A

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Biosint S.p.A	Via del Murillo 16, Sermoneta, Latina 04013, Italy (ITA)	Active ingredient (API) manufacture	3002806601428954135

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	levocarnitine	powder	59380-018BULK INGREDIENT

Neighbours

Registered in the same town

Latina Pharma S.P.A.Sermoneta, ITA

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Enquiry

Common questions

Is Biosint S.p.A FDA approved?: Biosint S.p.A 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 Biosint S.p.A's drugs manufactured?: The FDA register lists Sermoneta. Registered operations: active ingredient (API) manufacture.
What drugs does Biosint S.p.A make?: 1 product is listed under Biosint S.p.A 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.