Overview

FARMHISPANIA SA is an active pharmaceutical ingredient (API) supplier with 17 active FDA Type II Drug Master Files, covering ATRACURIUM BESYLATE USP; BENAZEPRIL HYDROCHLORIDE USP; CISATRACURIUM BESYLATE USP; DECITABINE; DEUTETRABENAZINE; ENALAPRIL MALEATE.

API / Drug Master Files

FARMHISPANIA SA holds 17 active (26 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.

  • EVEROLIMUS (2.0% BHT) USP-PROCESS IIActive2025-10-06
  • ROCURONIUM BROMIDE USP-PROCESS IIActive2025-05-29
  • GEMCITABINE HYDROCHLORIDE USPActive2024-07-29
  • METFORMIN HYDROCHLORIDE + 0.5% MAGNESIUM STEARATEActive2022-11-08
  • DEUTETRABENAZINEActive2022-08-02
  • TACROLIMUS USPActive2021-04-23
  • SUGAMMADEX SODIUMActive2020-10-29
  • EVEROLIMUS (2.0% BHT)Active2019-12-20
  • DECITABINEActive2019-10-08
  • CISATRACURIUM BESYLATE USPActive2011-05-30
  • ROCURONIUM BROMIDE USPActive2006-09-15
  • QUINAPRIL HYDROCHLORIDEActive2003-07-25
  • BENAZEPRIL HYDROCHLORIDE USPActive2001-05-04
  • MILRINONEActive1999-07-01
  • METFORMIN HYDROCHLORIDEActive1998-11-24

Showing 15 of 26 Drug Master Files.

FDA compliance signals

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

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