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), UZPHARM (UZ) and EMA, 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 X, Hungary Not on file
BUDAPEST, 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 Azelastine API Cariprazine API Cilostazol finished dose Cinnarizine finished dose Cobalamin finished dose Cyproterone finished dose Dabigatran Etexilate finished dose Desogestrel API Dienogest API Digoxin finished dose Dimenhydrinate finished dose
Show 47 more molecule pages
Drospirenone API Edoxaban finished dose Enzalutamide finished dose Estetrol API Estradiol API Ethinylestradiol API Etonogestrel API Famotidine API Ferrous finished dose Fluconazole API Ganirelix finished dose Ibandronate finished dose Ibandronic Acid finished dose Indapamide finished dose Ivabradine finished dose Ketamine finished dose Levonorgestrel API Lisinopril finished dose Mebendazole finished dose Norethisterone API Norgestimate API Norgestrel API Ondansetron API Oxytocin finished dose Paroxetine API Pazopanib finished dose Perindopril Tert-Butylamine finished dose Prasugrel finished dose Prilocaine finished dose Progesterone finished dose Relugolix finished dose Rizatriptan finished dose Selenious Acid finished dose Sodium Alendronate API Sorafenib finished dose Spironolactone API Terbinafine API Teriparatide finished dose Ticagrelor finished dose Tolperisone finished dose Triamcinolone finished dose Triamcinolone Acetonide finished dose Trimetazidine finished dose Ulipristal finished dose Vincristine API Vinpocetine API Vortioxetine 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

Questions about “Gedeon Richter”

Does “Gedeon Richter” hold a US DMF or a CEP?
“Gedeon Richter” holds 15 active US drug master files and 30 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does “Gedeon Richter” manufacture?
4 registered sites are on record, in United Arab Emirates, Switzerland and Hungary (Budapest, Genève and Budapest X among others). Every site is listed on this page with the register it came from.
What does “Gedeon Richter” make?
29 molecules are on record against “Gedeon Richter”, including Drospirenone, Ethinylestradiol, Famotidine and Gestodene. Each links through to that molecule's full manufacturer list.
Which regulators recognise “Gedeon Richter”'s GMP?
Current GMP certificates are on record from ANVISA (Brazil), UZPHARM (UZ), EMA and NAFDAC (NG). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • 4 active litigation matters are on record.

Comparable suppliers

Lupin shares 9 molecules Apitoria Pharma shares 8 molecules Industriale Chimica shares 8 molecules Dr Reddy's Laboratories shares 7 molecules Bayer S/A shares 7 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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