Is EGIS Pharmaceuticals PLC FDA approved?

EGIS Pharmaceuticals PLC holds 1 FDA-registered establishment 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 EGIS Pharmaceuticals PLC's drugs manufactured?

The FDA register lists Budapest. Registered operations: analytical testing, active ingredient (API) manufacture, packaging, repackaging.

What drugs does EGIS Pharmaceuticals PLC make?

3 products are listed under EGIS Pharmaceuticals PLC in the openFDA NDC Directory, most often as powder; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

EGIS Pharmaceuticals PLC

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

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

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Packaging1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
EGIS Pharmaceuticals PLC	Kereszturi �t 30-38, Budapest, 1106, Hungary (HUN)	Analytical testing, Active ingredient (API) manufacture, Packaging, Repackaging	3002806880643315815

Catalogue

Drug listings by form and route

3 active NDC listings: 3 bulk ingredient. By marketing category: BULK INGREDIENT 2, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.

Dosage form	NDCs
powder	2
liquid	1

Route	NDCs

Labeller name on the listing	NDCs
egis pharmaceuticals plc	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Crotamiton	liquid	48581-310BULK INGREDIENT
-	Ethacrynic Acid	powder	48581-320BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Promethazine Hydrochloride	powder	48581-114BULK INGREDIENT

Neighbours

Registered in the same town

EUROAPIBudapest, HUN
Gedeon Richter Plc.Budapest, HUN
Xellia Pharmaceuticals ApSBudapest, HUN

Compare

Comparable companies in Hungary

Teva Pharmaceutical Works Private Limited Company1 site · 22 NDC
Gedeon Richter Plc.3 sites · 11 NDC

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Common questions

Is EGIS Pharmaceuticals PLC FDA approved?: EGIS Pharmaceuticals PLC holds 1 FDA-registered establishment 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 EGIS Pharmaceuticals PLC's drugs manufactured?: The FDA register lists Budapest. Registered operations: analytical testing, active ingredient (API) manufacture, packaging, repackaging.
What drugs does EGIS Pharmaceuticals PLC make?: 3 products are listed under EGIS Pharmaceuticals PLC in the openFDA NDC Directory, most often as powder; liquid. 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.