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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances SUMITOMO CHEMICAL 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
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
1 FDA enforcement record linked to this company.
- warning_letter2009-08-24
FDA Warning Letter (drug product)
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