Kyowa Hakko USA Inc.

KYOWA HAKKO USA is the North American sales office for KYOWA HAKKO BIO, a pioneer in development and application of fermentation technology that maintains commitment to research, developing innovative new products and quality management. Branded ingredients include Setria® Glutathione, IMMUSE™ Lactococcus lactis strain Plasma, Cognizin® Citicoline, Pantesin® Pantethine, VELOX® Performance Blend, EYEMUSE™ Lacticaseibacillus paracasei, as well as other amino acids made in Japan and the US.
Catalog

Citicoline
Citicoline product image
Documents
Amino Nucleic

Lacticaseibacillus paracasei KW 3110
Lacticaseibacillus paracasei KW 3110 product image
Documents
Food Ingredient: Dried Lacticaseibacillus paracasei powder (inactivated)

L-Alanyl-L-Glutamine
L-Alanyl-L-Glutamine product image
Documents
L-alanyl-L-glutamine dipeptide

L-Glutathione Reduced
L-Glutathione Reduced product image
Documents
Amino acid, widely used for dietary supplement.

Pantesin HF55
Pantesin HF55 product image
Documents
Dietary Supplement

Pantethine A
Pantethine A product image
Documents
Dietary Supplement

Pyridoxal-5-Phosphate
Documents
Vitamin B6 derivative
Locations
Location name Address
Alfresa Fine Chemical Corporation 1-10-1 Mukaihama Akita, 05 010-1601 JPN
CMIC CMO Co., Ltd. 1-588 Kanaya-azuma Shimada, 22 4280013 JPN
Jing Jing pharmaceutical Co., Ltf. No.88, Jingyi Road, Dacaozhuang Industrial Zone, Ningjin County Xingtai, HE 055550 CHN
Koiwai Dairy Products Co., Ltd. Kamihirose 1254 Sayama-shi, 11 350-1231 JPN
Kyowa Hakko Bio Co., Ltd 1-1 Kyowa-cho Hofu-chi, 35 755-8522 JPN
Kyowa Hakko USA, Inc. 600 Third Ave. New York, NY 10016 USA
Sekisui Medical Co., Ltd.- Iwate Plant 4-115 Matsuo Hachimantai, 03 028-7305 JPN
Documents
Type Location
Bioterrorism Letter Kyowa Hakko Bio Co., Ltd
Recall/Emergency/Contact List Kyowa Hakko Bio Co., Ltd
Recall/Emergency/Contact List Kyowa Hakko USA, Inc.
Ethical Code of Conduct Kyowa Hakko USA, Inc.
Audit Kyowa Hakko Bio Co., Ltd
3rd Party Audit Certificate Kyowa Hakko USA, Inc.
Food Defense Plan Statement Alfresa Fine Chemical Corporation
HARPC Food Safety Plan (Facility) Alfresa Fine Chemical Corporation
Allergen Control Policy CMIC CMO Co., Ltd.
PFAS Kyowa Hakko Bio Co., Ltd
FDA Registration CMIC CMO Co., Ltd.
Bioterrorism Letter CMIC CMO Co., Ltd.
COA Sekisui Medical Co., Ltd.- Iwate Plant
Insurance Kyowa Hakko USA, Inc.
Copies of FDA Establishment Inspection Reports, Form 483s and/or warning letters received Kyowa Hakko Bio Co., Ltd
Ethical Code of Conduct Kyowa Hakko Bio Co., Ltd
Environmental Policy Kyowa Hakko USA, Inc.
Supplier Code of Conduct Kyowa Hakko Bio Co., Ltd
Supplier/Contract Manufacturer Qualification Questionnaire CMIC CMO Co., Ltd.
Site Quality Overview CMIC CMO Co., Ltd.
Environmental Policy Kyowa Hakko Bio Co., Ltd
HACCP Plan (Facility) Kyowa Hakko Bio Co., Ltd
HARPC Food Safety Plan (Facility) Kyowa Hakko Bio Co., Ltd
Recall Plan Kyowa Hakko Bio Co., Ltd
Recall Plan Sekisui Medical Co., Ltd.- Iwate Plant
Supplier Approval Program Statement Kyowa Hakko Bio Co., Ltd
HARPC Food Safety Plan (Facility) Sekisui Medical Co., Ltd.- Iwate Plant
HACCP Plan (Facility) Sekisui Medical Co., Ltd.- Iwate Plant
Food Defense Plan Statement Sekisui Medical Co., Ltd.- Iwate Plant
FDA Registration Alfresa Fine Chemical Corporation
Bioterrorism Letter Alfresa Fine Chemical Corporation
FDA Registration Kyowa Hakko Bio Co., Ltd
Food Defense Plan Statement CMIC CMO Co., Ltd.
Food Defense Plan Statement Kyowa Hakko Bio Co., Ltd
Supplier Approval Program Statement Kyowa Hakko USA, Inc.
Food Safety Modernization Act FSMA Kyowa Hakko Bio Co., Ltd
Organizational Chart Sekisui Medical Co., Ltd.- Iwate Plant
Organizational Chart CMIC CMO Co., Ltd.
GFSI Certificate Kyowa Hakko Bio Co., Ltd
3rd Party Audit Certificate Kyowa Hakko Bio Co., Ltd
Supplier/Contract Manufacturer Qualification Questionnaire Kyowa Hakko Bio Co., Ltd
Ethical Code of Conduct CMIC CMO Co., Ltd.
W-9 Kyowa Hakko USA, Inc.
Letter of Guarantee Kyowa Hakko Bio Co., Ltd
Letter of Guarantee Kyowa Hakko USA, Inc.
Letter of Guarantee Alfresa Fine Chemical Corporation
Letter of Guarantee Sekisui Medical Co., Ltd.- Iwate Plant
Lot Number and Traceability Procedure Kyowa Hakko Bio Co., Ltd
3rd Party Audit Certificate CMIC CMO Co., Ltd.
3rd Party Audit Certificate Alfresa Fine Chemical Corporation
3rd Party Audit Certificate Sekisui Medical Co., Ltd.- Iwate Plant
3rd Party Audit Corrective Action Plan Sekisui Medical Co., Ltd.- Iwate Plant
3rd Party Audit Corrective Action Plan CMIC CMO Co., Ltd.
3rd Party Audit Corrective Action Plan Kyowa Hakko USA, Inc.
3rd Party Audit Corrective Action Plan Alfresa Fine Chemical Corporation
3rd Party Audit Corrective Action Plan Kyowa Hakko Bio Co., Ltd
3rd Party Audit Report Kyowa Hakko USA, Inc.
3rd Party Audit Report Sekisui Medical Co., Ltd.- Iwate Plant
3rd Party Audit Report CMIC CMO Co., Ltd.
3rd Party Audit Report Alfresa Fine Chemical Corporation
3rd Party Audit Report Kyowa Hakko Bio Co., Ltd
Allergen Control Policy Kyowa Hakko USA, Inc.
Allergen Control Policy Alfresa Fine Chemical Corporation
Allergen Control Policy Kyowa Hakko Bio Co., Ltd
Audit Sekisui Medical Co., Ltd.- Iwate Plant
Bioterrorism Letter Kyowa Hakko USA, Inc.
Copy of written supply chain program Kyowa Hakko Bio Co., Ltd
CTPAT Kyowa Hakko Bio Co., Ltd
FDA Registration Kyowa Hakko USA, Inc.
Flow Chart Kyowa Hakko Bio Co., Ltd
Food Defense Plan Statement Kyowa Hakko USA, Inc.
Freezer Process and Validation Kyowa Hakko Bio Co., Ltd
GFSI Audit Report Kyowa Hakko USA, Inc.
GFSI Audit Report Kyowa Hakko Bio Co., Ltd
GFSI Certificate CMIC CMO Co., Ltd.
GFSI Certificate Kyowa Hakko USA, Inc.
GFSI Corrective Action Kyowa Hakko Bio Co., Ltd
GMP Certificate / Statement Kyowa Hakko Bio Co., Ltd
HACCP Plan (Facility) Kyowa Hakko USA, Inc.
HACCP Plan (Facility) CMIC CMO Co., Ltd.
HARPC Food Safety Plan (Facility) Kyowa Hakko USA, Inc.
Insurance Kyowa Hakko Bio Co., Ltd
Process Flow Chart Kyowa Hakko Bio Co., Ltd
Quality Manual CMIC CMO Co., Ltd.
Site Quality Overview Kyowa Hakko USA, Inc.
SOP Index CMIC CMO Co., Ltd.
SOP Index Kyowa Hakko Bio Co., Ltd
Supplier Approval Program Statement CMIC CMO Co., Ltd.
Supplier Qualification - Quality Agreement SQQA Kyowa Hakko Bio Co., Ltd
Supplier Questionnaire Kyowa Hakko USA, Inc.
Sustainability (Level 1) Kyowa Hakko USA, Inc.
Sustainability (Level 2) Kyowa Hakko USA, Inc.
Organizational Chart Kyowa Hakko Bio Co., Ltd
CA Transparency Act Kyowa Hakko Bio Co., Ltd
CA Transparency Act Kyowa Hakko USA, Inc.
Recall Plan Kyowa Hakko USA, Inc.
Recall Plan Alfresa Fine Chemical Corporation
Site Quality Overview Kyowa Hakko Bio Co., Ltd
Recall/Emergency/Contact List CMIC CMO Co., Ltd.
Recall Plan CMIC CMO Co., Ltd.
Supplier Questionnaire - Addendum Kyowa Hakko USA, Inc.
Supplier Questionnaire CMIC CMO Co., Ltd.
Supplier Questionnaire Sekisui Medical Co., Ltd.- Iwate Plant
Supplier Questionnaire Kyowa Hakko Bio Co., Ltd
Supplier Questionnaire Setria (L-Glutathione Reduced) CMO
Supplier Questionnaire Alfresa Fine Chemical Corporation
Copy of written supply chain program CMIC CMO Co., Ltd.
Sustainability (Level 1) CMIC CMO Co., Ltd.
Sustainability (Level 1) Kyowa Hakko Bio Co., Ltd
Sustainability (Level 2) Kyowa Hakko Bio Co., Ltd