Overview

HERAEUS PRECIOUS METALS GMBH AND CO KG is an active pharmaceutical ingredient (API) supplier with 9 active FDA Type II Drug Master Files, covering 5-AMINOLEVULINIC ACID HYDROCHLORIDE; ARSENIC TRIOXIDE USP; BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE; CARBOPLATIN USP; CISPLATIN USP; DACARBAZINE, USP.

API / Drug Master Files

HERAEUS PRECIOUS METALS GMBH AND CO KG holds 9 active (9 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.

  • BENDAMUSTINE HYDROCHLORIDE MONOHYDRATEActive2011-11-18
  • 5-AMINOLEVULINIC ACID HYDROCHLORIDEActive2010-11-12
  • OXALIPLATIN PROCESS HER-2 USPActive2006-12-19
  • ARSENIC TRIOXIDE USPActive2006-12-13
  • OXALIPLATINActive2006-07-28
  • CARBOPLATIN USPActive2000-11-17
  • THIOTEPA USPActive1998-12-24
  • DACARBAZINE, USPActive1998-02-13
  • CISPLATIN USPActive1986-11-01

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to HERAEUS PRECIOUS METALS GMBH AND CO KG in our records. PharmaTek screens the full directory against live FDA enforcement data.

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