Is Fresenius Kabi Austria GmbH FDA approved?

Fresenius Kabi Austria GmbH holds 2 FDA-registered establishments in Austria. 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 Fresenius Kabi Austria GmbH's drugs manufactured?

The FDA register lists Austria 8055; Linz. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, repackaging.

What drugs does Fresenius Kabi Austria GmbH make?

4 products are listed under Fresenius Kabi Austria GmbH in the openFDA NDC Directory, most often as emulsion; injection; powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Fresenius Kabi Austria GmbH

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

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Registered sites: 2
Active NDC listings: 4
Labeller names: 2
Live patents: 0
Countries: 1
Base: Austria

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Finished drug manufacture2Packaging1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Fresenius Kabi Austria	Hafnerstrasse 36 or am Gewerbepark 6, Graz, Werndorf, Austria 8055, 8402, Austria (AUT)	Analytical testing, Finished drug manufacture, Packaging, Repackaging	3003708554300206604
Fresenius Kabi Austria GmbH	Estermannstrasse 17, Linz, / 4020, Austria (AUT)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3002807014303448575

Catalogue

Drug listings by form and route

4 active NDC listings: 3 human prescription drug, 1 bulk ingredient. By marketing category: ANDA 1, BULK INGREDIENT 1, DRUG FOR FURTHER PROCESSING 1, NDA 1.

Dosage form	NDCs
emulsion	1
injection	1
powder	1
solution	1

Route	NDCs
intravenous	1
oral	1
rectal	1

Labeller name on the listing	NDCs
fresenius kabi austria gmbh	3
fresenius kabi austria gmbh	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cleviprex	clevidipine	emulsion, intravenous	18124-011NDA
Lactulose	Lactulose	solution, oral, rectal	18124-002ANDA
-	Lactulose	powder	18124-007BULK INGREDIENT
-	hydroxyprogesterone caproate	injection	18124-016DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

Patheon Manufacturing Services LLCLinz, AUT

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Enquiry

Common questions

Is Fresenius Kabi Austria GmbH FDA approved?: Fresenius Kabi Austria GmbH holds 2 FDA-registered establishments in Austria. 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 Fresenius Kabi Austria GmbH's drugs manufactured?: The FDA register lists Austria 8055; Linz. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, repackaging.
What drugs does Fresenius Kabi Austria GmbH make?: 4 products are listed under Fresenius Kabi Austria GmbH in the openFDA NDC Directory, most often as emulsion; injection; powder. 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.