Is Lek d.d. FDA approved?

Lek d.d. holds 2 FDA-registered establishments in Slovenia. 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 Lek d.d.'s drugs manufactured?

The FDA register lists Lendava; Ljubljana. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, relabelling, repackaging, sterilize.

What drugs does Lek d.d. make?

3 products are listed under Lek d.d. 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.

Lek d.d.

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

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

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Labelling2Finished drug manufacture2Packaging2particle size reduction1Relabelling1Repackaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Lek d.d.	2 D Trimlini, Lendava, - 9220, Slovenia (SVN)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002807463500735511
Lek d.d.	Verovskova Ulica 57, Ljubljana, - 1526, Slovenia (SVN)	Analytical testing, Labelling, Finished drug manufacture, Packaging, particle size reduction, Relabelling, Repackaging, sterilize	3002807460364704288

Catalogue

Drug listings by form and route

3 active NDC listings: 3 bulk ingredient. By marketing category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 3.

Dosage form	NDCs
powder	3

Route	NDCs

Labeller name on the listing	NDCs
lek d.d.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Clavulanate Potassium diluted with Microcrystalline Cellulose	powder	48866-9981BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Clavulanate Potassium diluted with Silicon Dioxide	powder	48866-9982BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Gentamicin Sulfate	powder	48866-8256BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Neighbours

Registered in the same town

Novartis Pharmaceuticals CorporationLjubljana, SVN

Enquiry

Common questions

Is Lek d.d. FDA approved?: Lek d.d. holds 2 FDA-registered establishments in Slovenia. 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 Lek d.d.'s drugs manufactured?: The FDA register lists Lendava; Ljubljana. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, relabelling, repackaging, sterilize.
What drugs does Lek d.d. make?: 3 products are listed under Lek d.d. 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.