Is CSL Limited FDA approved?

CSL Limited holds 5 FDA-registered establishments across 4 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 CSL Limited's drugs manufactured?

At registered sites in Australia, Switzerland, Germany, the United States. The FDA register lists Broadmeadows; Bern; Lengnau; Marburg; Bradley, IL. Registered operations: finished drug manufacture.

What drugs does CSL Limited make?

1 product is listed under CSL Limited in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

CSL Limited

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

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Registered sites: 5
Active NDC listings: 1
Live patents: 0
Countries: 4
Base: Switzerland

Authorisation

Registered operations

Finished drug manufacture5

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
CSL Behring (Australia) Pty LtdRegistrant: CSL Limited	189-209 Camp Road, Broadmeadows, Victoria 3047, Australia (AUS)	Finished drug manufacture	3001644620747286672
CSL Behring AGRegistrant: CSL Limited	Wankdorfstrasse 10, Bern, CH, Switzerland (CHE)	Finished drug manufacture	3002806716481152762
CSL Behring Lengnau AGRegistrant: CSL Limited	Biotech Innovation Park, Lengnau, 2543, Switzerland (CHE)	Finished drug manufacture	3021666267480217014
CSL Behring GmbHRegistrant: CSL Limited	Emil von Behring Strasse 76, Marburg, Hesse 35041, Germany (DEU)	Finished drug manufacture	3003098680326530474
CSL Behring L.L.C.Registrant: CSL Limited	1201 N Kinzie Ave, Bradley, Illinois (IL) 60915, United States (USA)	Finished drug manufacture	1410248058268293

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ANDEMBRY	Garadacimab	injection, solution, subcutaneous	63833-925BLA

Neighbours

Registered in the same town

Janssen Research & Development, L.L.C.Bern, CHE
GlaxoSmithKline Biologicals SAMarburg, DEU
BioNTech Manufacturing GmbHMarburg, DEU

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Enquiry

Common questions

Is CSL Limited FDA approved?: CSL Limited holds 5 FDA-registered establishments across 4 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 CSL Limited's drugs manufactured?: At registered sites in Australia, Switzerland, Germany, the United States. The FDA register lists Broadmeadows; Bern; Lengnau; Marburg; Bradley, IL. Registered operations: finished drug manufacture.
What drugs does CSL Limited make?: 1 product is listed under CSL Limited in the openFDA NDC Directory, most often as injection, 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.