KD SWISS GMBH

Overview

KD SWISS GMBH is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering EPA 500 ETHYL ESTER INTERMEDIATE (ICOSAPENT ETHYL); EPA 670 ETHYL ESTER INTERMEDIATE (ICOSAPENT ETHYL); HIGH EPA INTERMEDIATE FISH OIL.

API / Drug Master Files

KD SWISS GMBH holds 3 active (3 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.

  • EPA 500 ETHYL ESTER INTERMEDIATE (ICOSAPENT ETHYL)Active2024-07-05
  • EPA 670 ETHYL ESTER INTERMEDIATE (ICOSAPENT ETHYL)Active2022-07-15
  • HIGH EPA INTERMEDIATE FISH OILActive2011-11-22

FDA compliance signals

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

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