Egis Pharmaceuticals PLC

Overview

Egis Pharmaceuticals PLC is a leading pharmaceutical company based in Hungary, known for developing and manufacturing high-quality generic drugs and active pharmaceutical ingredients. The company serves a wide range of therapeutic areas and is committed to innovation and quality in the healthcare industry.

Therapeutic areas

API / Drug Master Files

Egis Pharmaceuticals PLC holds 3 active (6 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• ABEMACICLIB USPActive2026-03-27
• ETHACRYNIC ACIDActive2004-02-26
• PROMETHAZINE HCLActive1989-01-24
• BUTAMINE HYDROCHLORIDE DRUG SUBSTANCE INTERMEDIATEInactive2014-02-28
• ROSUVASTATINInactive2010-02-26
• CHLORPROMAZINE HClInactive1984-11-09

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Egis Pharmaceuticals PLC in our records. PharmaTek screens the full directory against live FDA enforcement data.