Overview

SEKISUI MEDICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering CLEMASTINE FUMERATE; EPSILON-AMINO-N-CAPROIC ACID; L-METHIONINE; N-ACETYL-DL-TRYPTOPHAN; N-ACETYL-L-TYROSINE; TAURINE.

API / Drug Master Files

SEKISUI MEDICAL CO LTD holds 6 active (7 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.

  • N-ACETYL-L-TYROSINEActive2005-03-01
  • TAURINEActive2004-12-01
  • N-ACETYL-DL-TRYPTOPHANActive1992-10-23
  • CLEMASTINE FUMERATEActive1987-03-06
  • EPSILON-AMINO-N-CAPROIC ACIDActive1985-08-14
  • L-METHIONINEActive1983-05-31
  • L-LEUCINE DRUG SUBSTANCEInactive1987-10-19

FDA compliance signals

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

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