Astellas Pharma US, Inc.

Overview

Astellas Pharma US, Inc. is a subsidiary of Astellas Pharma Inc., a leading pharmaceutical company based in Japan. The company focuses on improving the health of people around the world through innovative and reliable treatments.

Therapeutic areas

Active pharmaceutical ingredients supplied

Substances Astellas Pharma US, Inc. 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

Astellas Pharma US, Inc. holds 2 active (21 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.

• TACROLIMUS (FK506) DRUG SUBSTANCEActive2003-09-12
• FK463 DRUG SUBSTANCEActive1998-02-11
• FK1706Inactive2005-03-31
• FK555 DRUG SUBSTANCEInactive2004-09-15
• FK330 DRUG SUBSTANCEInactive2004-04-22
• FK962Inactive2004-02-19
• FK 881 DRUG SUBSTANCEInactive2003-06-27
• FK778 DRUG SUBSTANCEInactive2001-08-06
• FK-866 DRUG SUBSTANCEInactive2000-04-04
• CEFAZOLIN SODIUM (STERILE)Inactive1998-09-01
• YM087 DRUG SUBSTANCEInactive1998-02-10
• FORMOTEROL FUMARATEInactive1997-02-24
• TAMSULOSIN HYDROCHLORIDEInactive1995-12-01
• CEFIXIMEInactive1991-12-31
• 7 ACA-A48Inactive1991-12-16

Showing 15 of 21 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Astellas Pharma US, Inc. in our records. PharmaTek screens the full directory against live FDA enforcement data.