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.

Core services & business areas

API ManufacturingPharmaceutical Manufacturing

Active pharmaceutical ingredients supplied

Substances ICROM SRL is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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.

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