Is Ablynx FDA approved?

Ablynx 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 Ablynx's drugs manufactured?

The FDA register lists ZWIJNAARDE. Registered operations: analytical testing, finished drug manufacture.

Ablynx

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

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

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Ablynx	Technologiepark-Zwijnaarde 21 Gent,, ZWIJNAARDE, 9052, Belgium (BEL)	Analytical testing, Finished drug manufacture	3008915297372000096

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Common questions

Is Ablynx FDA approved?: Ablynx 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 Ablynx's drugs manufactured?: The FDA register lists ZWIJNAARDE. 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.