Is argenx BV FDA approved?

argenx BV holds 1 FDA-registered establishment in Belgium. 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 argenx BV's drugs manufactured?

The FDA register lists Gent. Registered operations: finished drug manufacture.

What drugs does argenx BV make?

3 products are listed under argenx BV in the openFDA NDC Directory, most often as injection, solution; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

argenx BV

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

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Registered sites: 1
Active NDC listings: 3
Live patents: 0
Countries: 1
Base: Belgium

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
argenx BV	Industriepark Zwijnaarde 7, Gent, 9052, Belgium (BEL)	Finished drug manufacture	3015102398400523378

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: BLA 3.

Dosage form	NDCs
injection, solution	2
injection	1

Route	NDCs
subcutaneous	2
intravenous	1

Labeller name on the listing	NDCs
argenx us	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
VYVGART	EFGARTIGIMOD ALFA	injection, intravenous	73475-3041BLA
VYVGART Hytrulo	efgartigimod alfa and hyaluronidase (human recombinant)	injection, solution, subcutaneous	73475-1221BLA
VYVGART Hytrulo	efgartigimod alfa and hyaluronidase (human recombinant)	injection, solution, subcutaneous	73475-3102BLA

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Common questions

Is argenx BV FDA approved?: argenx BV holds 1 FDA-registered establishment in Belgium. 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 argenx BV's drugs manufactured?: The FDA register lists Gent. Registered operations: finished drug manufacture.
What drugs does argenx BV make?: 3 products are listed under argenx BV in the openFDA NDC Directory, most often as injection, solution; injection. 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.