ICROM SRL

Overview

ICROM SRL is an active pharmaceutical ingredient (API) supplier with 11 active FDA Type II Drug Master Files, covering AMISULPRIDE; BEPOTASTINE BESILATE; BRINZOLAMIDE (MICRONIZED, MICRONIZED AND STERILE); EPINASTINE HYDROCHLORIDE; FLUORESCEIN SODIUM; INDOCYANINE GREEN.

API / Drug Master Files

ICROM SRL holds 11 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.

• FLUORESCEIN SODIUMActive2024-02-01
• INDOCYANINE GREENActive2023-10-31
• METHYLENE BLUEActive2021-12-02
• RISPERIDONEActive2021-06-28
• METOCLOPRAMIDE HCLActive2018-06-19
• AMISULPRIDEActive2017-07-11
• FLUORESCEIN SODIUMActive2015-03-05
• BEPOTASTINE BESILATEActive2013-08-27
• BRINZOLAMIDE (MICRONIZED, MICRONIZED AND STERILE)Active2011-11-07
• EPINASTINE HYDROCHLORIDEActive2008-07-28
• MINOXIDILActive2004-03-23

FDA compliance signals

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