Is CZECH-GEN, a.s. FDA approved?

CZECH-GEN, a.s. holds 1 FDA-registered establishment in Czechia. 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 CZECH-GEN, a.s.'s drugs manufactured?

The FDA register lists Olomouc - Klasterni Hradisko. Registered operations: active ingredient (API) manufacture.

What drugs does CZECH-GEN, a.s. make?

11 products are listed under CZECH-GEN, a.s. 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.

CZECH-GEN, a.s.

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

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Registered sites: 1
Active NDC listings: 11
Labeller names: 2
Live patents: 0
Countries: 1
Base: Czechia

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
CZECH-GEN, a.s.	Na vl?cinci 16/3, Olomouc - Klasterni Hradisko, 779 00, Czech Republic (CZE)	Active ingredient (API) manufacture	3002806982643526296

Catalogue

Drug listings by form and route

11 active NDC listings: 11 bulk ingredient. By marketing category: BULK INGREDIENT 11.

Dosage form	NDCs
powder	11

Route	NDCs

Labeller name on the listing	NDCs
czech-gen, a.s.	10
czech-gen, a,s	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Alfuzosin Hydrochloride	powder	63278-0500BULK INGREDIENT
-	Brimonidine Tartrate	powder	63278-0488BULK INGREDIENT
-	DOFETILIDE	powder	63278-1079BULK INGREDIENT
-	Eszopiclone	powder	63278-1059BULK INGREDIENT
-	REGADENOSON MONOHYDRATE	powder	63278-1068BULK INGREDIENT
-	RILUZOLE	powder	63278-1076BULK INGREDIENT
-	Selegiline Hydrochloride	powder	63278-0102BULK INGREDIENT
-	Tizanidine Hydrochloride	powder	63278-0489BULK INGREDIENT
-	Warfarin Sodium	powder	63278-1058BULK INGREDIENT
-	ZOPICLONE	powder	63278-1060BULK INGREDIENT
-	Zolpidem Tartrate	powder	63278-0490BULK INGREDIENT

Compare

Comparable companies in Czechia

Teva Czech Industries s.r.o.1 site · 41 NDC
TAPI Czech Industries s.r.o.1 site · 32 NDC
Macco Organiques, S.r.o.1 site · 30 NDC
Cayman Pharma s.r.o.1 site · 7 NDC
Contipro a.s.1 site · 2 NDC
VUAB Pharma A.S.1 site · 1 NDC
Synthesia, a.s.2 sites · 1 NDC
Synthon Pharmaceuticals, Inc.4 sites · 1 NDC

Enquiry

Common questions

Is CZECH-GEN, a.s. FDA approved?: CZECH-GEN, a.s. holds 1 FDA-registered establishment in Czechia. 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 CZECH-GEN, a.s.'s drugs manufactured?: The FDA register lists Olomouc - Klasterni Hradisko. Registered operations: active ingredient (API) manufacture.
What drugs does CZECH-GEN, a.s. make?: 11 products are listed under CZECH-GEN, a.s. 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.