Suppliers / Egis Pharmaceuticals

Egis Pharmaceuticals

Hungary Updated 9 July 2026

Egis Pharmaceuticals is an API and finished-dose manufacturer based in Hungary. It holds 3 active US drug master files and 4 valid CEPs across a filed portfolio of 7 molecules. Its filings concentrate with RAMA (GE), RCETH (BY) and DIGEMAPS (DO). Its GMP standing is certified by EAEU_EEC. Its most recent recorded inspection, by US FDA, closed on 8 June 2018 as NAI.

3
active US DMFs
4
valid CEPs
3
registered plants 1 with an FDA FEI number
563
filings across 20 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 8 June 2018 NAI US FDA
  • 8 November 2013 NAI US FDA
  • 28 January 2011 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Budapest, United Arab Emirates Not on file
Budapest X, Hungary Not on file
Hungary, Hungary 3002806880

What they file, and where

Molecule Regulators Docs
Promethazine SFDA (Saudi Arabia), US FDA 2
Rosuvastatin Zinc Tetrahydrate EDQM 2
Abemaciclib US FDA 1
Amlodipine SFDA (Saudi Arabia) 1
Bisoprolol EDQM 1
Carvedilol EDQM 1
Etacrynic Acid US FDA 1

Also appears on these molecule pages

Allopurinol finished dose Ambroxol finished dose Amlodipine API Atorvastatin finished dose Bisoprolol API Bromhexine finished dose Carvedilol API Cilostazol finished dose Clopidogrel finished dose Drospirenone finished dose Ezetimibe finished dose Letrozole finished dose
Show 19 more molecule pages
Levocetirizine finished dose Meloxicam finished dose Metoprolol finished dose Nifedipine finished dose Olanzapine finished dose Perindopril finished dose Piracetam finished dose Piroxicam finished dose Quetiapine finished dose Ramipril finished dose Rivaroxaban finished dose Rosuvastatin finished dose Sacubitril finished dose Sertraline finished dose Tamoxifen finished dose Tamsulosin finished dose Telmisartan finished dose Trimetazidine finished dose Venlafaxine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
RAMA (GE) 109 None
RCETH (BY) 90 None
DIGEMAPS (DO) 90 None
DAV (Vietnam) 71 None
AIFA (IT) 46 None
UZPHARM (UZ) 39 None
EAEU_EEC None 4

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Open risk flags

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was NAI, on 8 June 2018.

Sources on this page

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