Is Bavarian Nordic A/S FDA approved?

Bavarian Nordic A/S 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 Bavarian Nordic A/S's drugs manufactured?

At registered sites in Switzerland, Germany, Denmark. The FDA register lists Th�rishaus; Martinsried; Kvistgaard. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Bavarian Nordic A/S make?

10 products are listed under Bavarian Nordic A/S in the openFDA NDC Directory, most often as injection, suspension; injection, powder, lyophilized, for suspension; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Bavarian Nordic A/S

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

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Registered sites: 3
Active NDC listings: 10
Live patents: 0
Countries: 3
Base: Germany

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture2Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Bavarian Nordic Berna GmbHRegistrant: Bavarian Nordic A/S	Oberriedstrasse 68, Th�rishaus, Bern 3174, Switzerland (CHE)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3011237656480030654
Bavarian Nordic GmbHRegistrant: Bavarian Nordic A/S	Fraunhoferstra�e 13, Martinsried, 82152, Germany (DEU)	Analytical testing	3005565792314328944
Bavarian Nordic A/S	Hejreskovvej 10A, Kvistgaard, Denmark 3490, Denmark (DNK)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3008318564306197198

Catalogue

Drug listings by form and route

10 active NDC listings: 10 vaccine. By marketing category: BLA 10.

Dosage form	NDCs
injection, suspension	4
injection, powder, lyophilized, for suspension	2
kit	2
capsule, coated	1
liquid	1

Route	NDCs
subcutaneous	6
intramuscular	1
oral	1

Labeller name on the listing	NDCs
bavarian nordic a/s	10

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Diluent Component	Water for Injection	liquid, subcutaneous	50632-003BLA
JYNNEOS	Vaccinia Virus Modified Strain Ankara-Bavarian Nordic Non-Replicating Antigen	injection, suspension, subcutaneous	50632-001BLA
JYNNEOS	Vaccinia Virus Modified Strain Ankara-Bavarian Nordic Non-Replicating Antigen	injection, powder, lyophilized, for suspension, subcutaneous	50632-002BLA
JYNNEOS	Vaccinia Virus Modified Strain Ankara-Bavarian Nordic Non-Replicating Antigen	injection, suspension, subcutaneous	50632-022BLA
JYNNEOS	Vaccinia Virus Modified Strain Ankara-Bavarian Nordic Non-Replicating Antigen	injection, suspension, subcutaneous	50632-023BLA
JYNNEOS	Vaccinia Virus Modified Strain Ankara-Bavarian Nordic Non-Replicating Antigen	injection, powder, lyophilized, for suspension, subcutaneous	50632-024BLA
RabAvert	Rabies Vaccine	kit	50632-010BLA
VIMKUNYA	Chikungunya Vaccine, Recombinant	injection, suspension, intramuscular	50632-018BLA
Vaxchora	Cholera Vaccine, Live, Oral	kit	50632-015BLA
Vivotif	Salmonella typhi Ty21a	capsule, coated, oral	50632-016BLA

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Enquiry

Common questions

Is Bavarian Nordic A/S FDA approved?: Bavarian Nordic A/S 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 Bavarian Nordic A/S's drugs manufactured?: At registered sites in Switzerland, Germany, Denmark. The FDA register lists Th�rishaus; Martinsried; Kvistgaard. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Bavarian Nordic A/S make?: 10 products are listed under Bavarian Nordic A/S in the openFDA NDC Directory, most often as injection, suspension; injection, powder, lyophilized, for suspension; kit. 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.