Is NOBILUS ENT TOMASZ KOZLUK FDA approved?

NOBILUS ENT TOMASZ KOZLUK holds 1 FDA-registered establishment in Poland. 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 NOBILUS ENT TOMASZ KOZLUK's drugs manufactured?

The FDA register lists Kutno. Registered operations: analytical testing, active ingredient (API) manufacture, labelling.

What drugs does NOBILUS ENT TOMASZ KOZLUK make?

3 products are listed under NOBILUS ENT TOMASZ KOZLUK in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

NOBILUS ENT TOMASZ KOZLUK

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

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Registered sites: 1
Active NDC listings: 3
Labeller names: 2
Live patents: 0
Countries: 1
Base: Poland

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
NOBILUS ENT ODDZIAL KUTNORegistrant: NOBILUS ENT TOMASZ KOZLUK	Ul. Metalowa 6a, Kutno, 99-300, Poland (POL)	Analytical testing, Active ingredient (API) manufacture, Labelling	3008517755422437025

Catalogue

Drug listings by form and route

3 active NDC listings: 3 bulk ingredient. By marketing category: BULK INGREDIENT 3.

Dosage form	NDCs
powder	3

Route	NDCs

Labeller name on the listing	NDCs
nobilus ent tomasz kozluk	2
nobilus ent tomasz kozluk	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Digoxin	powder	59695-0001BULK INGREDIENT
-	Digoxin	powder	59695-0002BULK INGREDIENT
-	Digoxin	powder	59695-0004BULK INGREDIENT

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Enquiry

Common questions

Is NOBILUS ENT TOMASZ KOZLUK FDA approved?: NOBILUS ENT TOMASZ KOZLUK holds 1 FDA-registered establishment in Poland. 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 NOBILUS ENT TOMASZ KOZLUK's drugs manufactured?: The FDA register lists Kutno. Registered operations: analytical testing, active ingredient (API) manufacture, labelling.
What drugs does NOBILUS ENT TOMASZ KOZLUK make?: 3 products are listed under NOBILUS ENT TOMASZ KOZLUK in the openFDA NDC Directory, most often as 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.