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

Abemaciclib API Allopurinol finished dose Ambroxol finished dose Amlodipine API Aripiprazole finished dose Atorvastatin finished dose Bisoprolol API Bromhexine finished dose Buspirone finished dose Captopril finished dose Carvedilol API Cilostazol finished dose
Show 33 more molecule pages
Clomifene finished dose Clopidogrel finished dose Deferasirox finished dose Donepezil finished dose Drospirenone finished dose Ezetimibe finished dose Ferrous finished dose Levocetirizine finished dose Meloxicam finished dose Metoprolol finished dose Nifedipine finished dose Nitroglycerin finished dose Olanzapine finished dose Perindopril finished dose Piracetam finished dose Piroxicam finished dose Povidone-Iodine finished dose Promethazine API Quetiapine finished dose Ramipril finished dose Rivaroxaban finished dose Ropinirole finished dose Rosuvastatin finished dose Sacubitril finished dose Sacubitril/Valsartan finished dose Sertraline finished dose Sunitinib finished dose Tamoxifen finished dose Tamsulosin finished dose Telmisartan finished dose Terazosin 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

Questions about Egis Pharmaceuticals

Does Egis Pharmaceuticals hold a US DMF or a CEP?
Egis Pharmaceuticals holds 3 active US drug master files and 4 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.
Is Egis Pharmaceuticals FDA-registered?
One site operated by Egis Pharmaceuticals carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Egis Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 8 June 2018 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Egis Pharmaceuticals manufacture?
3 registered sites are on record, in United Arab Emirates and Hungary (Budapest, Budapest X and Hungary). Every site is listed on this page with the register it came from.
What does Egis Pharmaceuticals make?
7 molecules are on record against Egis Pharmaceuticals, including Promethazine, Rosuvastatin Zinc Tetrahydrate, Abemaciclib and Amlodipine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Egis Pharmaceuticals's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union). 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

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

Comparable suppliers

Apitoria Pharma shares 3 molecules Cipla shares 3 molecules Dr Reddy's Laboratories shares 3 molecules Zydus Lifesciences shares 3 molecules Ipca Laboratories shares 3 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