Suppliers / “Gedeon Richter”

“Gedeon Richter”

Hungary RGEDF 2 duplicate records merged Updated 9 July 2026

“Gedeon Richter” is an API and finished-dose manufacturer based in Hungary. It holds 15 active US drug master files and 30 valid CEPs across a filed portfolio of 29 molecules. Its filings concentrate with EMA, AIFA (IT) and RAMA (GE). Its GMP standing is certified by ANVISA (Brazil), EMA and UZPHARM (UZ), among 4 authorities.

15
active US DMFs
30
valid CEPs
4
registered plants
1,465
filings across 28 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Budapest, United Arab Emirates Not on file
Genève, Switzerland Not on file
BUDAPEST, Hungary Not on file
Budapest X, Hungary Not on file

What they file, and where

Molecule Regulators Docs
Drospirenone EDQM, SFDA (Saudi Arabia), US FDA 7
Ethinylestradiol EDQM, SFDA (Saudi Arabia) 5
Famotidine EDQM, US FDA 3
Gestodene EDQM, SFDA (Saudi Arabia) 3
Amlodipine EDQM, SFDA (Saudi Arabia) 2
Cariprazine SFDA (Saudi Arabia), US FDA 2
Desogestrel EDQM, US FDA 2
Estradiol EDQM, US FDA 2
Levonorgestrel EDQM, US FDA 2
Norgestimate EDQM, US FDA 2
Show all 29 molecules on file
Norgestrel US FDA 2
Spironolactone EDQM, US FDA 2
Terbinafine EDQM, US FDA 2
Amlodipine Besilate EDQM 1
Azelastine US FDA 1
Chlormadinone Acetate SFDA (Saudi Arabia) 1
Dienogest EDQM 1
Estetrol US FDA 1
Estradiol Hemihydrate EDQM 1
Etonogestrel US FDA 1
Fluconazole EDQM 1
Norelgestromin US FDA 1
Norethisterone EDQM 1
Ondansetron EDQM 1
Paroxetine EDQM 1
Sodium Alendronate Trihydrate EDQM 1
Vinblastine EDQM 1
Vincristine EDQM 1
Vinpocetine EDQM 1

Also appears on these molecule pages

Amlodipine API Cilostazol finished dose Desogestrel API Digoxin finished dose Dimenhydrinate finished dose Drospirenone API Estradiol API Ethinylestradiol API Famotidine API Fluconazole API Ibandronic Acid finished dose Indapamide finished dose
Show 13 more molecule pages
Levonorgestrel API Lisinopril finished dose Mebendazole finished dose Norethisterone API Ondansetron API Paroxetine API Progesterone finished dose Spironolactone API Terbinafine API Ticagrelor finished dose Triamcinolone finished dose Triamcinolone Acetonide finished dose Trimetazidine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 306 2
AIFA (IT) 195 None
RAMA (GE) 137 None
FAMHP (BE) 129 None
RCETH (BY) 126 None
INFARMED (PT) 85 None
ANVISA (Brazil) None 4
UZPHARM (UZ) None 2
NAFDAC (NG) None 1

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Open risk flags

  • 4 active litigation matters are on record.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates