SUMITOMO CHEMICAL CO LTD

Overview

SUMITOMO CHEMICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering BNC-1021; DISOPYRAMIDE PHOSPHATE USP; HYDRALAZINE HYDROCHLORIDE; SM-13496.

API / Drug Master Files

SUMITOMO CHEMICAL CO LTD holds 4 active (29 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.

• BNC-1021Active2018-02-26
• SM-13496Active2002-07-15
• DISOPYRAMIDE PHOSPHATE USPActive1982-10-14
• HYDRALAZINE HYDROCHLORIDEActive1975-03-14
• R BACLOFENInactive2009-06-22
• BICALUTAMIDE DRUG SUBSTANCEInactive2006-03-31
• PBL (A STARTING MATERIAL FOR MANUFACTURING DRUG SUBSTANCES)Inactive2005-11-30
• PBL (A STARTING MATERIAL FOR MANUFACTURING DRUG SUBSTANCES)Inactive2005-11-11
• SNK-860Inactive2004-05-24
• CITALOPRAM HYDROBROMIDEInactive2002-01-31
• MIRTAZAPINEInactive2001-02-22
• MCC-555Inactive1999-12-28
• POTASSIUM OTASTATInactive1998-12-22
• PAROXETINE HYDROCHLORIDE ANHYDRATEInactive1998-12-07
• BMCB(INERMEDIATE)Inactive1997-08-29

Showing 15 of 29 Drug Master Files.

FDA compliance signals

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