Kyowa Hakko Kirin Co., Ltd.
Overview
Kyowa Hakko Kirin Co., Ltd. is a Japan-based pharmaceutical company engaged in the research, development, manufacture and sale of pharmaceuticals and bio-chemicals. It is a leading biotechnology and healthcare company, with a focus on novel biopharmaceuticals and other innovative solutions.
Therapeutic areas
API / Drug Master Files
Kyowa Hakko Kirin Co., Ltd. holds 0 active (4 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.
- ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCEInactive2010-07-01
- KRN7000Inactive2001-01-12
- KRN5500 DRUG SUBSTANCEInactive1998-08-05
- UCN-01 (KW-2401) BULK SUBSTANCEInactive1995-01-20
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to Kyowa Hakko Kirin Co., Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.
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