Overview

EPAX NORWAY AS is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering EPAX 4608 EE US PH (EPA-ENRICHED FATTY ACID ETHYL ESTER).

Core services & business areas

API Manufacturing

API / Drug Master Files

EPAX NORWAY AS holds 1 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.

  • EPAX 4608 EE US PH (EPA-ENRICHED FATTY ACID ETHYL ESTER)Active2011-12-20
  • EPAX 5010 EE US PhInactive2018-06-26
  • EPAX 6015 TGN US APIInactive2013-07-22

FDA compliance signals

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

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