Takeda Pharmaceutical Company Limited
Overview
Takeda Pharmaceutical Company Limited is a leading global biopharmaceutical company, focusing on innovative medicines and vaccines. Takeda operates in various therapeutic areas, leveraging its expertise to improve health and offer treatments that change lives. As of 2016, it acquired Baxalta Incorporated, expanding its robust portfolio. Takeda is the parent company, with Baxalta now integrated into its operations.
Therapeutic areas
API / Drug Master Files
Takeda Pharmaceutical Company Limited holds 3 active (6 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.
- TAP-144-SR (1M)Active1995-03-24
- LEUPROLIDE ACETATEActive1993-08-13
- TAP-144-SR (3M) (22.5MG.)Active1991-09-30
- HYDROMORPHONE HYDROCHLORIDEInactive1987-07-13
- LUPRON DEPOT AND LUPRON DEPOT VEHICLEInactive1987-06-09
- FOLIC ACIDInactive1974-08-23
FDA compliance signals
17 FDA enforcement records linked to this company.
- warning_letter2020-06-10
FDA Warning Letter (drug product)
- 4832019-11-26
Procedures for sterile drug products
- 4832019-11-26
Written procedures fail to include
- 4832019-11-26
Validation lacking for sterile drug products
- 4832019-11-26
Procedures not in writing, fully followed
- 4832019-11-26
Failing drug products not rejected
- 4832019-11-26
Cleaning / Sanitizing / Maintenance
- 4832019-11-26
Extent of discrepancy, failure investigations
- 4832019-08-09
Validation lacking for sterile drug products
- 4832019-08-09
Procedure Deviations Recorded and Justified
- 4832019-08-09
Complete test data included in records
- 4832019-08-09
Scientifically sound laboratory controls
- 4832013-09-06
Investigations of discrepancies, failures
- 4832013-09-06
Procedures not in writing, fully followed
- 4832013-09-06
Control procedures to monitor and validate performance
Related companies
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.