KANEKA CORPORATION JAPAN

Overview

KANEKA CORPORATION JAPAN is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering UBIDECARENONE.

API / Drug Master Files

KANEKA CORPORATION JAPAN holds 1 active (5 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.

• UBIDECARENONEActive2015-11-10
• KPM-1648Inactive1995-01-05
• MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT TAKASAGO-SHI HYOGO, JAPANInactive1994-10-28
• N2-[1-(S)-ETHOXYCARBONYL 1-3-PHENYLPROPYL]-N6-TRIFLUOROACETYL-L-LYSYL-L-PROLINE.Inactive1994-09-01
• (4S,6S)-5, 6-DIHYDRO-4-HYDROXY-6-METHYL-4H-THIENO[2,3-B]THIOPYRAN 7,7-DIOXIDE ("HSOT")Inactive1993-08-30

FDA compliance signals

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