Astellas Pharma Inc.
Overview
Astellas Pharma Inc. is a Japanese multinational pharmaceutical company focused on improving the health of people around the world by providing innovative and reliable pharmaceutical products. The company is engaged in the research, development, manufacturing, and marketing of prescription drugs across a wide range of therapeutic areas.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Astellas Pharma 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 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
21 FDA enforcement records linked to this company.
- 4832025-06-06
Absence of Written Procedures
- 4832025-06-06
Validation lacking for sterile drug products
- recall — Class I2025-02-05
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- recall — Class I2025-02-05
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- 4832023-10-27
Complaint Investigation/Follow-Up Findings
- 4832019-03-05
Control procedures to monitor and validate performance
- 4832019-03-05
Procedures for sterile drug products
- 4832019-03-05
Investigations of discrepancies, failures
- 4832019-03-05
Calibration/Inspection/Checking not done
- 4832019-03-05
Protective Apparel Not Worn
- 4832019-03-05
Annual visual exams of drug products
- 4832019-03-05
Scientifically sound laboratory controls
- 4832019-03-05
Written in-process control procedures
- recall — Class II2018-02-14
Labeling: Label Error on Declared Strength
- recall — Class II2014-10-15
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Is this Astellas Pharma Inc.? Get in front of buyers actively sourcing.
We route real sourcing requests from pharma buyers to vetted, verified partners — qualified leads, not just a listing. Tell us what you make and we'll be in touch about becoming a Verified Supplier Partner.
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 7 days.