Is Novavax, Inc. FDA approved?

Novavax, Inc. holds 3 FDA-registered establishments across 2 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 Novavax, Inc.'s drugs manufactured?

At registered sites in Sweden, the United States. The FDA register lists Uppsala; Gaithersburg, MD; Germantown, MD. Registered operations: analytical testing, finished drug manufacture.

Novavax, Inc.

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

Request a quote Claim this profile

Registered sites: 3
Active NDC listings: 0
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing2Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Novavax ABRegistrant: Novavax, Inc.	Kungsgatan 109, Uppsala, 753 18, Sweden (SWE)	Analytical testing, Finished drug manufacture	3011188401632703880
Novavax, Inc.	620 Professional Dr, Gaithersburg, Maryland (MD) 20879-3413, United States (USA)	Finished drug manufacture	3018866553118278849
Novavax, Inc.	20425 Seneca Meadows Parkway, Germantown, Maryland (MD) 20876-7005, United States (USA)	Analytical testing	3021336765118906768

Neighbours

Registered in the same town

Eurofins BioPharma Product Testing Sweden ABUppsala, SWE · 2 sites
Fresenius Kabi USA, LLCUppsala, SWE
Precigen, IncGermantown, MD

Compare

Comparable companies in United States

International Medication Systems, Ltd.3 sites · 2,801 NDC
Alk-Abello, Inc.3 sites · 412 NDC
Conopco, Inc. d/b/a Unilever3 sites · 374 NDC
L. Perrigo Company3 sites · 243 NDC
Epic Laboratories, LLC3 sites · 209 NDC
Safecor Health, LLC3 sites · 103 NDC
ProPharma Distribution, LLC.3 sites · 100 NDC
B. Braun US Pharmaceutical Manufacturing LLC3 sites · 94 NDC
Aurolife Pharma LLC3 sites · 70 NDC
Elementis Specialties (India) Private Limited3 sites · 69 NDC

Enquiry

Common questions

Is Novavax, Inc. FDA approved?: Novavax, Inc. holds 3 FDA-registered establishments across 2 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 Novavax, Inc.'s drugs manufactured?: At registered sites in Sweden, the United States. The FDA register lists Uppsala; Gaithersburg, MD; Germantown, 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.