Is Gedeon Richter Plc. FDA approved?

Gedeon Richter Plc. holds 3 FDA-registered establishments in Hungary. 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 Gedeon Richter Plc.'s drugs manufactured?

The FDA register lists Budapest; Debrecen; Dorog. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Gedeon Richter Plc. make?

11 products are listed under Gedeon Richter Plc. in the openFDA NDC Directory, most often as powder; crystal; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Gedeon Richter Plc.

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

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Registered sites: 3
Active NDC listings: 11
Live patents: 0
Countries: 1
Base: Hungary

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture3Labelling1Finished drug manufacture2Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Richter Gedeon Nyrt.Registrant: Gedeon Richter Plc.	Gyomroi ut 19-21, Budapest, Budapest H-1103, Hungary (HUN)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002806761644781932
Richter Gedeon Nyrt.-Debrecen, Richter Gedeon utca 20. alatti telephelyRegistrant: Gedeon Richter Plc.	Richter Gedeon utca 20., Debrecen, HB 4031, Hungary (HUN)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3022999632301274815
Gedeon Richter Plc., Dorog siteRegistrant: Gedeon Richter Plc.	Esztergomi ut 27, Dorog, Komarom-Esztergom H-2510, Hungary (HUN)	Analytical testing, Active ingredient (API) manufacture	3002806762401140279

Catalogue

Drug listings by form and route

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

Dosage form	NDCs
powder	7
crystal	2
tablet	2

Route	NDCs

Labeller name on the listing	NDCs
gedeon richter plc.	11

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Desogestrel	crystal	45541-1191BULK INGREDIENT
-	Estradiol	powder	45541-1124BULK INGREDIENT
-	Etonogestrel	powder	45541-1192BULK INGREDIENT
-	Famotidine	powder	45541-1175BULK INGREDIENT
-	Levonorgestrel	powder	45541-1174BULK INGREDIENT
-	Levonorgestrel Tablet, 1.5 mg	tablet	45541-1248BULK INGREDIENT
-	Norelgestromin	powder	45541-1193BULK INGREDIENT
-	Norgestimate	crystal	45541-1162BULK INGREDIENT
-	Norgestrel	powder	45541-1149BULK INGREDIENT
-	Spironolactone	powder	45541-1134BULK INGREDIENT
-	levonorgestrel	tablet	45541-1244BULK INGREDIENT

Neighbours

Registered in the same town

EUROAPIBudapest, HUN
Xellia Pharmaceuticals ApSBudapest, HUN
EGIS Pharmaceuticals PLCBudapest, HUN
Teva Pharmaceutical Works Private Limited CompanyDebrecen, HUN

Compare

Comparable companies in Hungary

Teva Pharmaceutical Works Private Limited Company1 site · 22 NDC
EGIS Pharmaceuticals PLC1 site · 3 NDC

Enquiry

Common questions

Is Gedeon Richter Plc. FDA approved?: Gedeon Richter Plc. holds 3 FDA-registered establishments in Hungary. 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 Gedeon Richter Plc.'s drugs manufactured?: The FDA register lists Budapest; Debrecen; Dorog. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Gedeon Richter Plc. make?: 11 products are listed under Gedeon Richter Plc. in the openFDA NDC Directory, most often as powder; crystal; tablet. 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.