Is KELIX BIO (MALTA) LTD. FDA approved?

KELIX BIO (MALTA) LTD. holds 1 FDA-registered establishment in Malta. 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 KELIX BIO (MALTA) LTD.'s drugs manufactured?

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

KELIX BIO (MALTA) 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: Malta

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Kelix bio (Malta) Ltd.Registrant: KELIX BIO (MALTA) LTD.	HHF014 HALFAR INDUSTRIAL ESTATE, HALFAR, BIRZEBBUGIA, BBG3000, Malta (MLT)	Analytical testing, Finished drug manufacture, Packaging	3013541978565562764

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Common questions

Is KELIX BIO (MALTA) LTD. FDA approved?: KELIX BIO (MALTA) LTD. holds 1 FDA-registered establishment in Malta. 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 KELIX BIO (MALTA) LTD.'s drugs manufactured?: The FDA register lists BIRZEBBUGIA. Registered operations: analytical testing, 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.