SEKISUI MEDICAL CO LTD
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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances SEKISUI MEDICAL CO LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
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
1 FDA enforcement record linked to this company.
- warning_letter2016-11-08
FDA Warning Letter (drug product)
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