Is Kiniksa Pharmaceuticals (UK), Ltd. FDA approved?

Kiniksa Pharmaceuticals (UK), Ltd. 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 Kiniksa Pharmaceuticals (UK), Ltd.'s drugs manufactured?

At registered sites in Switzerland, the United Kingdom. The FDA register lists Zug; London. Registered operations: analytical testing, finished drug manufacture.

What drugs does Kiniksa Pharmaceuticals (UK), Ltd. make?

1 product is listed under Kiniksa Pharmaceuticals (UK), Ltd. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Kiniksa Pharmaceuticals (UK), Ltd.

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

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Registered sites: 3
Active NDC listings: 1
Live patents: 0
Countries: 2
Base: Switzerland

Authorisation

Registered operations

Analytical testing1Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Kiniksa Pharmaceuticals (UK), Ltd., London (UK), Zweigniederlassung ZugRegistrant: Kiniksa Pharmaceuticals (UK), Ltd.	Grafenaustrasse 5, Zug, Zug 6300, Switzerland (CHE)	Analytical testing	3041695195480625900
Kiniksa Pharmaceuticals, GmbH	Grafenaustrasse 5, Zug, Zug 6300, Switzerland (CHE)	Finished drug manufacture	3017125164480465527
Kiniksa Pharmaceuticals (UK), Ltd.	105 Picadilly, London, London, City of W1J 7NJ, United Kingdom (GBR)	Finished drug manufacture	3017952669224568777

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Arcalyst	rilonacept	injection, powder, lyophilized, for solution, subcutaneous	73604-914BLA

Neighbours

Registered in the same town

Wisdrug AGZug, CHE

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Enquiry

Common questions

Is Kiniksa Pharmaceuticals (UK), Ltd. FDA approved?: Kiniksa Pharmaceuticals (UK), Ltd. 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 Kiniksa Pharmaceuticals (UK), Ltd.'s drugs manufactured?: At registered sites in Switzerland, the United Kingdom. The FDA register lists Zug; London. Registered operations: analytical testing, finished drug manufacture.
What drugs does Kiniksa Pharmaceuticals (UK), Ltd. make?: 1 product is listed under Kiniksa Pharmaceuticals (UK), Ltd. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution. 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.