Is Valneva Austria GmbH FDA approved?

Valneva Austria GmbH holds 3 FDA-registered establishments across 3 countries. 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 Valneva Austria GmbH's drugs manufactured?

At registered sites in Austria, the United Kingdom, the United States. The FDA register lists Vienna; Livingston; Bethesda, MD. Registered operations: analytical testing, finished drug manufacture.

Valneva Austria GmbH

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

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Registered sites: 3
Active NDC listings: 0
Live patents: 0
Countries: 3
Base: United Kingdom

Authorisation

Registered operations

Analytical testing3Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Valneva Austria GmbH	Campus Vienna Biocenter 3, Vienna, Vienna 1030, Austria (AUT)	Analytical testing	3007480617300378693
Valneva Scotland Ltd.Registrant: Valneva Austria GmbH	Oakbank Park Road, Livingston, - EH53 0TG, United Kingdom (GBR)	Analytical testing, Finished drug manufacture	3005315117737272380
Valneva USA, Inc:Registrant: Valneva Austria GmbH	4550 Montgomery Avenue, suite 460, Bethesda, Maryland (MD) 20814, United States (USA)	Analytical testing	3012607736004431065

Neighbours

Registered in the same town

Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.Vienna, AUT
Eurofins BioPharma Product Testing India Private LimitedLivingston, GBR
Boehringer Ingelheim RCV GmbH & Co KGVienna, AUT
MW ENCAP LIMITEDLivingston, GBR

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Common questions

Is Valneva Austria GmbH FDA approved?: Valneva Austria GmbH holds 3 FDA-registered establishments across 3 countries. 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 Valneva Austria GmbH's drugs manufactured?: At registered sites in Austria, the United Kingdom, the United States. The FDA register lists Vienna; Livingston; Bethesda, MD. Registered operations: analytical testing, 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.