Kyowa Hakko Bio Co., Ltd.
Overview
Kyowa Hakko Bio Co., Ltd. is an innovative Japanese company specializing in the development, manufacturing, and marketing of fermentation-based products. Operating as a subsidiary of Kirin Holdings Company, Limited, Kyowa Hakko Bio focuses on biotechnology-driven solutions for health and nutrition.
Therapeutic areas
API / Drug Master Files
Kyowa Hakko Bio Co., Ltd. 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.
- MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE OXIDIZEDActive1988-12-02
- AMINO ACIDSActive1978-03-15
- AMINO ACIDSActive1978-02-27
- D-SERINE (BULK SUBSTANCE)Inactive2005-12-05
- MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE REDUCEDInactive1990-12-17
- AMINO ACID MIXTURESInactive1979-01-09
FDA compliance signals
2 FDA enforcement records linked to this company.
- warning_letter2018-08-10
FDA Warning Letter (drug product)
- warning_letter2010-09-29
FDA Warning Letter (drug product)
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