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
Active pharmaceutical ingredients supplied
Substances Kyowa Hakko Bio 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 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)
Is this Kyowa Hakko Bio Co., Ltd.? Get in front of buyers actively sourcing.
We route real sourcing requests from pharma buyers to vetted, verified partners — qualified leads, not just a listing. Tell us what you make and we'll be in touch about becoming a Verified Supplier Partner.
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 7 days.