Nippon Kayaku Co., Ltd.

Overview

Nippon Kayaku Co., Ltd. is a Japanese chemical company known for its diverse product lines, including functional chemicals, pharmaceuticals, and safety systems. It is a leader in the custom production of pharmaceuticals and agrochemicals.

Therapeutic areas

API / Drug Master Files

Nippon Kayaku Co., Ltd. holds 3 active (18 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.

• UBENIMEXActive2015-07-31
• ETOPOSIDE PHOSPHATEActive1993-09-17
• ETOPOSIDEActive1991-01-22
• MINOCYCLINE HYDROCHLORIDEInactive1998-09-01
• GRISEOFULVINInactive1998-09-01
• UBINIMEXInactive1993-01-22
• AUREOBASIDIN AInactive1992-09-24
• BOC-AHPBA-OH, INTERMEDIATE OF DRUG SUBSTANCEInactive1992-08-10
• BUTADIAMUPLATINInactive1988-01-20
• CARBIDOPAInactive1987-06-22
• SULINDACInactive1987-06-22
• DEOXYSPERGUALIN HYDROCHLORIDEInactive1986-08-12
• DEOXYSPERGUALIN HYDROCHLORIDE FOR INJECTIONInactive1986-08-12
• L-~-METHYLDOPAInactive1986-01-08
• SUCRALFATEInactive1985-09-27

Showing 15 of 18 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Nippon Kayaku Co., Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.