Elpen Pharmaceutical Co. Inc.

Overview

Elpen Pharmaceutical Co. Inc. is a leading pharmaceutical company based in Greece, specializing in the development, manufacture, and marketing of innovative medicinal products. It has a strong focus on research and development to address unmet medical needs.

Therapeutic areas

API / Drug Master Files

Elpen Pharmaceutical Co. Inc. holds 2 active (11 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.

• TRIFLURIDINE DRUG SUBSTANCEActive2020-03-16
• TIPIRACIL HYDROCHLORIDE (TPI)Active2014-11-25
• TAC-101 DRUG SUBSTANCEInactive2008-02-06
• WM-1-DAITO INTERMEDIATE FOR CDHPInactive2007-06-27
• IPD-1151T DRUG SUBSTANCEInactive2004-04-12
• GTS-21Inactive1999-12-28
• CDHPInactive1997-06-18
• TAS-103Inactive1996-05-31
• TEGAFURInactive1993-06-17
• UFT CAPSULES (TEGAFUR AND URACIL)Inactive1993-06-17
• FTORAFUR (ALSO CALLED FUTRAFUL OR TEGAFUR)Inactive1981-08-05

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Elpen Pharmaceutical Co. Inc. in our records. PharmaTek screens the full directory against live FDA enforcement data.