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
Documents
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Allergens
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Country of origin
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Item questionnaire
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Nutrition
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Product specification
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SDS (Safety Data Sheet)
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Suitability requirements
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Food Ingredient: Dried Lacticaseibacillus paracasei powder (inactivated)
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Allergens
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COA template
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Country of origin
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Item questionnaire
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Nutrition
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Product specification
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SDS (Safety Data Sheet)
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Suitability requirements
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L-alanyl-L-glutamine dipeptide
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Country of origin
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Item questionnaire
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Nutrition
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Product specification
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SDS (Safety Data Sheet)
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Suitability requirements
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Amino acid, widely used for dietary supplement.
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Country of origin
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Item questionnaire
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Nutrition
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Product specification
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SDS (Safety Data Sheet)
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Suitability requirements
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Dietary Supplement
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Allergens
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Country of origin
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Item questionnaire
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Nutrition
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Product specification
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SDS (Safety Data Sheet)
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Suitability requirements
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Dietary Supplement
Documents
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Allergens
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COA template
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Country of origin
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Item questionnaire
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Nutrition
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Product specification
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SDS (Safety Data Sheet)
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Suitability requirements
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Vitamin B6 derivative
Documents
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Allergens
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COA template
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Country of origin
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Item questionnaire
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Nutrition
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Product specification
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Click to download PS -
SDS (Safety Data Sheet)
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Click to download SDS -
Suitability requirements
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Click to download SR
Amino Nucleic
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 and Emergency Contact List | Kyowa Hakko Bio Co., Ltd |
| Recall and Emergency Contact List | Kyowa Hakko USA, Inc. |
| Code of Conduct | Kyowa Hakko USA, Inc. |
| Audit | Kyowa Hakko Bio Co., Ltd |
| Third-Party Audit Certificate | Kyowa Hakko USA, Inc. |
| Food Defense Plan Statement | Alfresa Fine Chemical Corporation |
| Preventive Controls Food Safety Plan (Location) | Alfresa Fine Chemical Corporation |
| Allergen Control Program | 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 Certificate | Kyowa Hakko USA, Inc. |
| Copies of FDA Establishment Inspection Reports, Form 483s and/or warning letters received | Kyowa Hakko Bio Co., Ltd |
| 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 |
| Preventive Controls Food Safety Plan (Location) | Kyowa Hakko Bio Co., Ltd |
| Recall Plan | Kyowa Hakko Bio Co., Ltd |
| Recall Plan | Sekisui Medical Co., Ltd.- Iwate Plant |
| Supplier Approval Program | Kyowa Hakko Bio Co., Ltd |
| Preventive Controls Food Safety Plan (Location) | 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 | Kyowa Hakko USA, Inc. |
| Food Safety Modernization Act FSMA | Kyowa Hakko Bio Co., Ltd |
| Organization Chart | Sekisui Medical Co., Ltd.- Iwate Plant |
| Organization Chart | CMIC CMO Co., Ltd. |
| GFSI Audit Certificate | Kyowa Hakko Bio Co., Ltd |
| Third-Party Audit Certificate | Kyowa Hakko Bio Co., Ltd |
| Supplier/Contract Manufacturer Qualification Questionnaire | Kyowa Hakko Bio Co., Ltd |
| Code of Conduct | CMIC CMO Co., Ltd. |
| Tax Documentation | Kyowa Hakko USA, Inc. |
| Letter of Continuing Guarantee | Kyowa Hakko Bio Co., Ltd |
| Letter of Continuing Guarantee | Kyowa Hakko USA, Inc. |
| Letter of Continuing Guarantee | Alfresa Fine Chemical Corporation |
| Letter of Continuing Guarantee | Sekisui Medical Co., Ltd.- Iwate Plant |
| Lot Number and Traceability Procedure | Kyowa Hakko Bio Co., Ltd |
| Third-Party Audit Certificate | CMIC CMO Co., Ltd. |
| Third-Party Audit Certificate | Alfresa Fine Chemical Corporation |
| Third-Party Audit Certificate | Sekisui Medical Co., Ltd.- Iwate Plant |
| Third-Party Audit Corrective Action Plan | Sekisui Medical Co., Ltd.- Iwate Plant |
| Third-Party Audit Corrective Action Plan | CMIC CMO Co., Ltd. |
| Third-Party Audit Corrective Action Plan | Kyowa Hakko USA, Inc. |
| Third-Party Audit Corrective Action Plan | Alfresa Fine Chemical Corporation |
| Third-Party Audit Corrective Action Plan | Kyowa Hakko Bio Co., Ltd |
| Third-Party Audit Report | Kyowa Hakko USA, Inc. |
| Third-Party Audit Report | Sekisui Medical Co., Ltd.- Iwate Plant |
| Third-Party Audit Report | CMIC CMO Co., Ltd. |
| Third-Party Audit Report | Alfresa Fine Chemical Corporation |
| Third-Party Audit Report | Kyowa Hakko Bio Co., Ltd |
| Allergen Control Program | Kyowa Hakko USA, Inc. |
| Allergen Control Program | Alfresa Fine Chemical Corporation |
| Allergen Control Program | 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 |
| Supply Chain Security Evidence | 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 Audit Certificate | CMIC CMO Co., Ltd. |
| GFSI Audit Certificate | Kyowa Hakko USA, Inc. |
| GFSI Audit Corrective Action Plan | 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. |
| Preventive Controls Food Safety Plan (Location) | Kyowa Hakko USA, Inc. |
| Insurance Certificate | 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 | 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. |
| Organization Chart | Kyowa Hakko Bio Co., Ltd |
| Modern Slavery Statement | Kyowa Hakko Bio Co., Ltd |
| Modern Slavery Statement | 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 and 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 |