Is Biofac A/S FDA approved?

Biofac A/S holds 1 FDA-registered establishment in Denmark. 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 Biofac A/S's drugs manufactured?

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

Biofac A/S

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: Denmark

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Biofac A/S	Ejbyvej 44, Lille Skensved, Sjaelland 4623, Denmark (DNK)	Active ingredient (API) manufacture	3004262697306274143

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Common questions

Is Biofac A/S FDA approved?: Biofac A/S holds 1 FDA-registered establishment in Denmark. 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 Biofac A/S's drugs manufactured?: The FDA register lists Lille Skensved. Registered operations: 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.