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.

Core services & business areas

Pharmaceutical ResearchDrug DevelopmentRegulatory AffairsSales and MarketingPharmaceutical ManufacturingQuality AssuranceResearch and Development

Therapeutic areas

Active pharmaceutical ingredients supplied

Substances Takeda Pharmaceutical Company Limited 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

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 not in writing, fully followed

  • 4832019-11-26

    Cleaning / Sanitizing / Maintenance

  • 4832019-11-26

    Procedures for sterile drug products

  • 4832019-11-26

    Failing drug products not rejected

  • 4832019-11-26

    Written procedures fail to include

  • 4832019-11-26

    Extent of discrepancy, failure investigations

  • 4832019-11-26

    Validation lacking for sterile drug products

  • 4832019-08-09

    Procedure Deviations Recorded and Justified

  • 4832019-08-09

    Validation lacking for sterile drug products

  • 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

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