ERCROS SA

Overview

ERCROS SA is an active pharmaceutical ingredient (API) supplier with 9 active FDA Type II Drug Master Files, covering ERYTHROMYCIN BASE; ERYTHROMYCIN BASE DIHYDRATE; ERYTHROMYCIN ETHYLSUCCINATE; FAMOTIDINE; FOSFOMYCIN PHENYLAMMONIUM SALT; FOSFOMYCIN SODIUM.

API / Drug Master Files

ERCROS SA holds 9 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.

• ERYTHROMYCIN BASE DIHYDRATEActive2022-09-14
• FOSFOMYCIN TROMETHAMINEActive2017-02-24
• FUSIDIC ACIDActive2007-04-27
• SODIUM FUSIDATEActive2007-03-29
• FOSFOMYCIN SODIUMActive1999-08-04
• ERYTHROMYCIN ETHYLSUCCINATEActive1998-09-01
• ERYTHROMYCIN BASEActive1998-09-01
• FAMOTIDINEActive1998-07-21
• FOSFOMYCIN PHENYLAMMONIUM SALTActive1995-07-10
• LOVASTATINInactive2004-01-05
• ERYTHROMYCIN ESTOLATEInactive1998-09-01

FDA compliance signals

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