Register entry

Seqirus, Inc.

Data as of · How to read this entry

Registered sites
3
Active NDC listings
2
Labeller names
2
Live patents
0
Countries
3
Base
Australia
Authorisation

Registered operations

Analytical testing3Labelling1Finished drug manufacture3Packaging1
Sites

Registered establishments

3
EstablishmentAddressRegistered forFEI / DUNS
Seqirus Pty LtdRegistrant: Seqirus, Inc.63 Poplar Road, Parkville, Victoria 3052, Australia (AUS)Analytical testing, Finished drug manufacture3002806753747286735
Seqirus Vaccines LimitedRegistrant: Seqirus, Inc.Gaskill Road, Liverpool, Speke L24 9GR, United Kingdom (GBR)Analytical testing, Finished drug manufacture3002806949233657951
Seqirus IncRegistrant: Seqirus, Inc.475 Green Oaks Parkway, Holly Springs, North Carolina (NC) 27540, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging3007867647080102141
Catalogue

Drug listings by form and route

2

2 active NDC listings: 2 vaccine. By marketing category: BLA 2.

Dosage formNDCs
injection, suspension2
RouteNDCs
intramuscular2
Labeller name on the listingNDCs
seqirus inc.1
seqirus, inc.1
Catalogue

Marketed products

2
BrandGeneric nameForm / routeNDC
FLUADINFLUENZA A VIRUS A/Missouri/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 IVR-285 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)injection, suspension, intramuscular70461-026BLA
FlucelvaxINFLUENZA A VIRUS A/Tasmania/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Tasmania/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Arizona/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)injection, suspension, intramuscular70461-656BLA
Neighbours

Registered in the same town

4
Compare

Comparable companies in Australia

Enquiry

Common questions

Is Seqirus, Inc. FDA approved?
Seqirus, Inc. 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 Seqirus, Inc.'s drugs manufactured?
At registered sites in Australia, the United Kingdom, the United States. The FDA register lists Parkville; Liverpool; Holly Springs, NC. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Seqirus, Inc. make?
2 products are listed under Seqirus, Inc. in the openFDA NDC Directory, most often as injection, suspension. 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.