Overview

Kyowa Kirin Co., Ltd. is a leading Japanese pharmaceutical company focused on creating new drugs that address unmet medical needs. It is a subsidiary of Kyowa Hakko Kirin Holdings Co., Ltd. and specializes in therapeutic areas such as oncology, nephrology, and immunology.

Core services & business areas

Pharmaceutical DevelopmentLicensingCommercializationRegulatory Affairs

Therapeutic areas

Active pharmaceutical ingredients supplied

Substances Kyowa Kirin 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

Kyowa Kirin Co., Ltd. holds 0 active (3 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.

  • KW-6356 DRUG SUBSTANCEInactive2014-11-06
  • ASKP1240 MONOCLONAL ANTIBODY DRUG SUBSTANCE AND DRUG PRODUCTInactive2008-05-08
  • OLOPATADINE HYDROCHLORIDE (KW 4679)Inactive1996-01-10

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Kyowa Kirin Co., Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.

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