Overview

ACE JAPAN CO LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering SUCRALFATE (SUCROSE SULFATE ALUMINUM SALT).

API / Drug Master Files

ACE JAPAN CO LTD holds 1 active (2 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.

  • SUCRALFATE (SUCROSE SULFATE ALUMINUM SALT)Active1985-10-11
  • PINDOLOLInactive2002-04-30

FDA compliance signals

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

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