Is IPSEN BIOPHARM LTD FDA approved?

IPSEN BIOPHARM LTD holds 1 FDA-registered establishment in the United Kingdom. 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 IPSEN BIOPHARM LTD's drugs manufactured?

The FDA register lists Wrexham. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

IPSEN BIOPHARM LTD

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: United Kingdom

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
IPSEN BIOPHARM LTD	Unit 9 Ash Road Wrexham Industrial Estate, Wrexham, LL 13 9UF, United Kingdom (GBR)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	1000346340365113203

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Common questions

Is IPSEN BIOPHARM LTD FDA approved?: IPSEN BIOPHARM LTD holds 1 FDA-registered establishment in the United Kingdom. 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 IPSEN BIOPHARM LTD's drugs manufactured?: The FDA register lists Wrexham. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

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.