Is Serumwerk Bernburg AG FDA approved?

Serumwerk Bernburg AG holds 1 FDA-registered establishment in Germany. 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.

Serumwerk Bernburg AG

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: Germany

Authorisation

Registered operations

Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Serumwerk Bernburg AG	Hallesche Landstra�e 105B, Bernburg, 06406, Germany (DEU)	Active ingredient (API) manufacture, Finished drug manufacture	3003903447330105057

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Common questions

Is Serumwerk Bernburg AG FDA approved?: Serumwerk Bernburg AG holds 1 FDA-registered establishment in Germany. 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 Serumwerk Bernburg AG's drugs manufactured?: The FDA register lists Bernburg. Registered operations: active ingredient (API) manufacture, 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.