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
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Allergens
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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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SDS (Safety Data Sheet)
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Postbiotic
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SDS (Safety Data Sheet)
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Human Milk Oligosaccharides (HMO)
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L-alanyl-L-glutamine dipeptide
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Human Milk Oligosaccharides (HMO)
Documents
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SDS (Safety Data Sheet)
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Amino Acid
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Dietary Supplement
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Dietary Supplement
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Amino Nucleic
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Vitamin B6 derivative
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Amino acid, widely used for dietary supplement.
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Amino Acid
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Allergens
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Item questionnaire
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Nutrition
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SDS (Safety Data Sheet)
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Suitability requirements
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Amino Acid
Locations
| Location name | Address |
|---|---|
| Alfresa Fine Chemical Corporation | 1-10-1 Mukaihama Akita, 05 010-1601 JPN |
| BioKyowa, Inc. | 5469 Nash Road Cape Girardeau, MO 63701 USA |
| 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 |
| Thai Kyowa Biotechnologies Co., Ltd. | 399 IRPC Industrial Zone, Moo 1, Tambon Choengnoen Amphur Muangrayong, 21 21000 THA |
Documents
| Type | Location | File name | Effective | Expiration |
|---|---|---|---|---|
| Sustainability (Level 2) | Kyowa Hakko USA, Inc. | -- | ||
| Supplier Questionnaire | Kyowa Hakko USA, Inc. | -- | ||
| Ethical Code of Conduct | Kyowa Hakko USA, Inc. | Additional info_Corporate Code of Ethics.pdf | 6/29/2022 | 6/28/2024 |
| 3rd Party Audit Certificate | Kyowa Hakko USA, Inc. | AFA audit to KHB_Certificate.pdf | 5/17/2022 | 5/31/2025 |
| 3rd Party Audit Certificate | Kyowa Hakko Bio Co., Ltd | AFA audit to KHB_Certificate.pdf | 5/17/2022 | 5/31/2025 |
| Audit | Kyowa Hakko Bio Co., Ltd | AFA audit to KHB_Certificate.pdf | 5/17/2022 | 5/31/2025 |
| 3rd Party Audit Report | Kyowa Hakko Bio Co., Ltd | AFA audit to KHB_Summary.pdf | 5/17/2022 | 5/31/2025 |
| Food Defense Plan Statement | Alfresa Fine Chemical Corporation | AFF FDP confirmation 2023.pdf | 3/12/2024 | 3/12/2026 |
| HARPC Food Safety Plan (Facility) | Alfresa Fine Chemical Corporation | AFF FSP confirmation 2023.pdf | 3/12/2024 | 12/31/2026 |
| Supplier Contact Verification | BioKyowa, Inc. | Agropur Ingredient - Supplier Contact Verification Form 20220119.docx | 11/3/2022 | 11/3/2023 |
| Allergen Control Policy | CMIC CMO Co., Ltd. | Allergen control program_CMIC.pdf | 1/12/2022 | 1/12/2024 |
| Allergen Control Policy | Kyowa Hakko Bio Co., Ltd | Allergen control program_KHB.pdf | 6/29/2022 | 6/28/2024 |
| Allergen Control Policy | BioKyowa, Inc. | Allergen cross contamination ARFGM-BK.pdf | 1/12/2022 | 1/12/2024 |
| GFSI Certificate | BioKyowa, Inc. | BioKyowa Inc FSSC 22000_Exp Jun 2025.pdf | 9/21/2023 | 6/30/2025 |
| 3rd Party Audit Certificate | BioKyowa, Inc. | BioKyowa ISO 9001 2015 Exp May 2025.pdf | 3/15/2022 | 5/20/2025 |
| Audit | BioKyowa, Inc. | BioKyowa ISO 9001 2015 Exp May 2025.pdf | 3/15/2022 | 5/20/2025 |
| HARPC Food Safety Plan (Facility) | Kyowa Hakko USA, Inc. | BioKyowa_FSPHACCP Manual 2018 front content.pdf | 9/10/2020 | 9/10/2023 |
| HACCP Plan (Facility) | BioKyowa, Inc. | BK_HACCP Manual 2023.pdf | 3/17/2023 | 3/16/2025 |
| Organizational Chart | BioKyowa, Inc. | BK_Organization chart_202008.pdf | 9/15/2023 | 9/14/2024 |
| CA Transparency Act | BioKyowa, Inc. | CA trasparancy act, BK.pdf | 9/12/2023 | 9/11/2025 |
| PFAS | Kyowa Hakko Bio Co., Ltd | Chemical (PFAS) Free declaration.pdf | 3/11/2024 | 12/31/2029 |
| Bioterrorism Letter | CMIC CMO Co., Ltd. | CMICCMO HF55 updateFacilityRegistration .pdf | 1/12/2022 | 1/12/2023 |
| FDA Registration | CMIC CMO Co., Ltd. | CMICCMO HF55 updateFacilityRegistration .pdf | 11/10/2020 | 12/31/2022 |
| COA | Sekisui Medical Co., Ltd.- Iwate Plant | CoA Sample.pdf | 3/20/2024 | 2/14/4762 |
| Insurance | BioKyowa, Inc. | COI_Nutrition 21_ LLC.pdf | 1/1/2024 | 12/31/2024 |
| Insurance | Kyowa Hakko USA, Inc. | COI_T. Hasegawa.pdf | 1/1/2024 | 12/31/2024 |
| Copies of FDA Establishment Inspection Reports, Form 483s and/or warning letters received | Kyowa Hakko Bio Co., Ltd | Conclusion od FDA inspection to YPC.pdf | 7/22/2022 | 7/21/2025 |
| Ethical Code of Conduct | BioKyowa, Inc. | CSV - Sustainability.pdf | 11/8/2023 | 11/7/2025 |
| Environmental Policy | Kyowa Hakko USA, Inc. | CSV - Sustainability.pdf | 11/8/2023 | 11/7/2024 |
| Sensient Supplier Code of Conduct | BioKyowa, Inc. | CSV - Sustainability.pdf | 11/8/2023 | 11/7/2026 |
| Ethical Code of Conduct | Kyowa Hakko Bio Co., Ltd | CSV - Sustainability.pdf | 11/8/2023 | 11/7/2025 |
| Supplier Code of Conduct | Kyowa Hakko Bio Co., Ltd | CSV - Sustainability.pdf | 11/8/2023 | 11/7/2025 |
| Supplier/Contract Manufacturer Qualification Questionnaire | CMIC CMO Co., Ltd. | Draft03_Self-Assessment_1-Y_CMIC2022.pdf | 3/20/2024 | 3/20/2027 |
| Environmental Policy | BioKyowa, Inc. | Environmental monitoring_BK.pdf | 9/12/2023 | 9/11/2024 |
| Environmental Monitoring Program | BioKyowa, Inc. | Environmental monitoring_BK.pdf | 12/13/2023 | 4/29/2051 |
| Environmental Monitoring Program (EMP) Policy | BioKyowa, Inc. | Environmental monitoring_BK.pdf | 9/12/2023 | 9/11/2025 |
| Environmental Policy | Kyowa Hakko Bio Co., Ltd | Environmental monitoring_KHB.pdf | 9/21/2023 | 9/20/2024 |
| HACCP Plan (Facility) | Kyowa Hakko Bio Co., Ltd | Establish food safety plan Hofu.pdf | 3/11/2024 | 3/11/2026 |
| HARPC Food Safety Plan (Facility) | BioKyowa, Inc. | Establish food safety plan, BK (2).pdf | 5/1/2023 | 4/30/2026 |
| HARPC Food Safety Plan (Facility) | Kyowa Hakko Bio Co., Ltd | Establish food safety plan, Hofu.pdf | 12/8/2023 | 12/7/2026 |
| Recall Plan | BioKyowa, Inc. | Establish recall plan, BK.pdf | 5/14/2024 | 5/14/2025 |
| Recall Plan | Kyowa Hakko USA, Inc. | Establish recall plan.pdf | 12/6/2023 | 12/5/2024 |
| Recall/Emergency/Contact List | BioKyowa, Inc. | Establish recall plan.pdf | 9/12/2023 | 9/11/2024 |
| Recall/Emergency/Contact List | Kyowa Hakko USA, Inc. | Establish recall plan.pdf | 12/6/2023 | 12/5/2024 |
| Recall Plan | Kyowa Hakko Bio Co., Ltd | Establish recall plan.pdf | 9/19/2023 | 9/18/2024 |
| Recall/Emergency/Contact List | Kyowa Hakko Bio Co., Ltd | Establish recall plan.pdf | 12/6/2023 | 12/5/2024 |
| Recall Plan | Sekisui Medical Co., Ltd.- Iwate Plant | Establish recall plan.pdf | 12/6/2023 | 12/5/2024 |
| Supplier Approval Program Statement | Kyowa Hakko Bio Co., Ltd | Establish Supplier approval program Hofu.pdf | 1/13/2020 | 1/12/2021 |
| Supplier Approval Program Statement | BioKyowa, Inc. | Establish Supplier approval program, BK.pdf | 9/12/2023 | 9/11/2024 |
| HARPC Food Safety Plan (Facility) | Sekisui Medical Co., Ltd.- Iwate Plant | Establishment of Food Safety Plan,P5P.pdf | 8/31/2023 | 12/31/2026 |
| Food Defense Plan Statement | Sekisui Medical Co., Ltd.- Iwate Plant | Establishment of Food Safety Plan,P5P.pdf | 3/15/2024 | 3/15/2026 |
| HACCP Plan (Facility) | Sekisui Medical Co., Ltd.- Iwate Plant | Establishment of Food Safety Plan,P5P.pdf | 9/6/2023 | 9/5/2025 |
| FDA Registration | Alfresa Fine Chemical Corporation | FDA registration number_Alfresa.pdf | 5/14/2024 | 12/31/2024 |
| Bioterrorism Letter | Alfresa Fine Chemical Corporation | FDA registration number_Alfresa.pdf | 5/14/2024 | 5/14/2025 |
| FDA Registration | BioKyowa, Inc. | FDA registration number_BK.pdf | 2/23/2022 | 12/31/2024 |
| Bioterrorism Letter | BioKyowa, Inc. | FDA registration number_BK.pdf | 9/12/2023 | 9/11/2024 |
| Bioterrorism Letter | Kyowa Hakko Bio Co., Ltd | FDA registration number_KHB.pdf | 12/6/2023 | 12/5/2024 |
| FDA Registration | Kyowa Hakko Bio Co., Ltd | FDA registration number_KHB.pdf | 9/19/2023 | 12/31/2026 |
| Food Defense Plan Statement | BioKyowa, Inc. | Food Defense program_BK.pdf | 1/12/2022 | 1/12/2024 |
| Food Defense Plan Statement | CMIC CMO Co., Ltd. | Food Defense program_CMIC.pdf | 1/12/2022 | 1/12/2024 |
| Food Defense Plan Statement | Kyowa Hakko Bio Co., Ltd | Food Defense program_KHB.pdf | 12/8/2023 | 12/7/2025 |
| FSMA Compliance Statement | BioKyowa, Inc. | FSMA compliance_BK (2).pdf | 12/8/2023 | 12/7/2025 |
| Supplier Approval Program Statement | Kyowa Hakko USA, Inc. | FSVP compliance statement.pdf | 12/1/2021 | 12/1/2022 |
| Food Safety Modernization Act FSMA | Kyowa Hakko Bio Co., Ltd | FSVP compliance, KHUS (KHB).pdf | 10/6/2022 | 10/5/2025 |
| Organizational Chart | Sekisui Medical Co., Ltd.- Iwate Plant | GMP organization cart.pdf | 9/6/2023 | 12/31/2025 |
| Organizational Chart | CMIC CMO Co., Ltd. | GMP Organization Chart.pdf | 1/12/2022 | 1/12/2023 |
| Supplier/Contract Manufacturer Qualification Questionnaire | Kyowa Hakko Bio Co., Ltd | KHB revision2020_Self-Assessment_KHB_20230201.pdf | 9/21/2023 | 9/20/2026 |
| Ethical Code of Conduct | CMIC CMO Co., Ltd. | KHUS Social Compliance Policy and Guidelines for Suppliers _ Rev. 2023.pdf | 3/20/2024 | 3/20/2026 |
| W-9 | Kyowa Hakko USA, Inc. | Kyowa Hakko W9 Form 2022 (signed).pdf | 12/6/2023 | 12/5/2026 |
| W-9 | BioKyowa, Inc. | Kyowa Hakko W9 Form 2022 (signed).pdf | 12/6/2023 | 12/5/2026 |
| Letter of Guarantee | BioKyowa, Inc. | Letter of Guarantee_ARF,CIT,GM-BK.pdf | 9/6/2023 | 9/5/2025 |
| Letter of Guarantee | Kyowa Hakko USA, Inc. | Letter of Guarantee_KHUS.pdf | 9/21/2023 | 9/20/2025 |
| Letter of Guarantee | Kyowa Hakko Bio Co., Ltd | Letter of Guarantee_KHUS.pdf | 9/21/2023 | 9/20/2025 |
| Letter of Guarantee | Alfresa Fine Chemical Corporation | Letter of Guarantee_LQ80.pdf | 5/14/2024 | 5/14/2026 |
| Letter of Guarantee | Sekisui Medical Co., Ltd.- Iwate Plant | Letter of Guarantee_P5P.pdf | 8/29/2023 | 8/28/2025 |
| Lot Number and Traceability Procedure | Kyowa Hakko Bio Co., Ltd | Lot Code_KHB.pdf | 3/11/2024 | 12/31/2029 |
| 3rd Party Audit Certificate | Sekisui Medical Co., Ltd.- Iwate Plant | NotApplicable_3rdPartyAuditCertificate.pdf | 5/14/2024 | 5/14/2025 |
| 3rd Party Audit Certificate | CMIC CMO Co., Ltd. | NotApplicable_3rdPartyAuditCertificate.pdf | 9/21/2023 | 9/21/2024 |
| 3rd Party Audit Certificate | Alfresa Fine Chemical Corporation | NotApplicable_3rdPartyAuditCertificate.pdf | 5/14/2024 | 5/14/2025 |
| 3rd Party Audit Corrective Action Plan | Kyowa Hakko USA, Inc. | NotApplicable_3rdPartyAuditCorrectiveActionPlan.pdf | 12/6/2023 | 12/6/2024 |
| 3rd Party Audit Corrective Action Plan | Kyowa Hakko Bio Co., Ltd | NotApplicable_3rdPartyAuditCorrectiveActionPlan.pdf | 8/22/2023 | 8/22/2024 |
| 3rd Party Audit Corrective Action Plan | Alfresa Fine Chemical Corporation | NotApplicable_3rdPartyAuditCorrectiveActionPlan.pdf | 3/12/2024 | 3/12/2025 |
| 3rd Party Audit Corrective Action Plan | Sekisui Medical Co., Ltd.- Iwate Plant | NotApplicable_3rdPartyAuditCorrectiveActionPlan.pdf | 8/30/2023 | 8/30/2024 |
| 3rd Party Audit Corrective Action Plan | BioKyowa, Inc. | NotApplicable_3rdPartyAuditCorrectiveActionPlan.pdf | 8/30/2023 | 8/30/2024 |
| 3rd Party Audit Corrective Action Plan | CMIC CMO Co., Ltd. | NotApplicable_3rdPartyAuditCorrectiveActionPlan.pdf | 9/21/2023 | 9/21/2024 |
| 3rd Party Audit Report | BioKyowa, Inc. | NotApplicable_3rdPartyAuditPrimary.pdf | 9/19/2023 | 12/31/2027 |
| 3rd Party Audit Report | Kyowa Hakko USA, Inc. | NotApplicable_3rdPartyAuditPrimary.pdf | 10/27/2020 | 12/31/2027 |
| 3rd Party Audit Report | CMIC CMO Co., Ltd. | NotApplicable_3rdPartyAuditReport.pdf | 9/21/2023 | 9/21/2024 |
| 3rd Party Audit Report | Alfresa Fine Chemical Corporation | NotApplicable_3rdPartyAuditReport.pdf | 3/12/2024 | 3/12/2025 |
| 3rd Party Audit Report | Sekisui Medical Co., Ltd.- Iwate Plant | NotApplicable_3rdPartyAuditReport.pdf | 8/30/2023 | 8/30/2024 |
| Allergen Control Policy | Kyowa Hakko USA, Inc. | NotApplicable_AllergenControlPolicy.pdf | 3/12/2024 | 3/12/2026 |
| Allergen Control Policy | Alfresa Fine Chemical Corporation | NotApplicable_AllergenControlPolicy.pdf | 3/12/2024 | 3/12/2026 |
| Audit | Sekisui Medical Co., Ltd.- Iwate Plant | NotApplicable_Audit.pdf | 9/6/2023 | 9/6/2024 |
| Bioterrorism Letter | Kyowa Hakko USA, Inc. | NotApplicable_BioterrorismLetter.pdf | 12/6/2023 | 12/5/2024 |
| COA | BioKyowa, Inc. | NotApplicable_COA.pdf | 5/2/2023 | 3/28/4761 |
| Copy of written supply chain program | Kyowa Hakko Bio Co., Ltd | NotApplicable_Copyofwrittensupplychainprogram.pdf | 5/14/2024 | 5/14/2027 |
| Copy of written supply chain program | BioKyowa, Inc. | NotApplicable_Copyofwrittensupplychainprogram.pdf | 5/14/2024 | 5/14/2027 |
| CTPAT | Kyowa Hakko Bio Co., Ltd | NotApplicable_CTPAT.pdf | 8/13/2024 | 8/13/2025 |
| FDA Registration | Kyowa Hakko USA, Inc. | NotApplicable_FDARegistration.pdf | 12/10/2021 | -- |
| Flow Chart | Kyowa Hakko Bio Co., Ltd | NotApplicable_FlowChart.pdf | 3/10/2024 | 3/10/2027 |
| Food Defense Plan Statement | Kyowa Hakko USA, Inc. | NotApplicable_FoodDefensePlanStatement.pdf | 1/13/2020 | 1/13/2025 |
| FSVP Assessment Form Supporting Document | BioKyowa, Inc. | NotApplicable_FSVPAssessmentFormSupportingDocument.pdf | 5/2/2023 | 5/2/2024 |
| GFSI Audit Report | Kyowa Hakko USA, Inc. | NotApplicable_GFSIAuditReport.pdf | 1/21/2022 | -- |
| GFSI Audit Report | Kyowa Hakko Bio Co., Ltd | NotApplicable_GFSIAuditReport.pdf | 9/21/2023 | 9/21/2024 |
| GFSI Certificate | CMIC CMO Co., Ltd. | NotApplicable_GFSICertificate.pdf | 1/12/2022 | -- |
| GFSI Certificate | Kyowa Hakko USA, Inc. | NotApplicable_GFSICertificate.pdf | 1/21/2022 | -- |
| GFSI Certificate | Kyowa Hakko Bio Co., Ltd | NotApplicable_GFSICertificate.pdf | 1/3/2022 | -- |
| GFSI Corrective Action | Kyowa Hakko Bio Co., Ltd | NotApplicable_GFSICorrectiveAction.pdf | 9/21/2023 | 9/21/2024 |
| GMP Certificate / Statement | Kyowa Hakko Bio Co., Ltd | NotApplicable_GMPCertificateStatement.pdf | 9/21/2023 | 9/20/2026 |
| GMP Standard Operating Procedure Index | BioKyowa, Inc. | NotApplicable_GMPStandardOperatingProcedureIndex.pdf | 9/6/2023 | 9/5/2026 |
| HACCP Plan (Facility) | CMIC CMO Co., Ltd. | NotApplicable_HACCPPlanFacility.pdf | 12/6/2023 | 12/5/2025 |
| HACCP Plan (Facility) | Kyowa Hakko USA, Inc. | NotApplicable_HACCPPlanFacility.pdf | 9/6/2023 | 9/5/2025 |
| Insurance | Kyowa Hakko Bio Co., Ltd | NotApplicable_Insurance.pdf | 12/6/2023 | 12/6/2024 |
| List of Manufacturer | BioKyowa, Inc. | NotApplicable_ListofManufacturer.pdf | 3/11/2024 | 3/11/2027 |
| Process Flow Chart | Kyowa Hakko Bio Co., Ltd | NotApplicable_ProcessFlowChart.pdf | 3/10/2024 | 3/10/2025 |
| Quality Manual | CMIC CMO Co., Ltd. | NotApplicable_QualityManual.pdf | 9/21/2023 | 9/20/2026 |
| Sanitation Procedure | BioKyowa, Inc. | NotApplicable_SanitationProcedure.pdf | 5/14/2024 | 5/14/2027 |
| Site Quality Overview | Kyowa Hakko USA, Inc. | NotApplicable_SiteQualityOverview.pdf | 12/6/2023 | 12/5/2025 |
| SOP Index | CMIC CMO Co., Ltd. | NotApplicable_SOPIndex.pdf | 5/14/2024 | 5/14/2027 |
| Supplier Approval Program Statement | CMIC CMO Co., Ltd. | NotApplicable_SupplierApprovalProgramStatement.pdf | 5/14/2024 | 5/14/2025 |
| Supplier Qualification - Quality Agreement SQQA | Kyowa Hakko Bio Co., Ltd | NotApplicable_SupplierQualificationQualityAgreementSQQA.pdf | 3/10/2024 | 3/10/2025 |
| Supplier Questionnaire | Kyowa Hakko USA, Inc. | NotApplicable_SupplierQuestionnaire.pdf | 3/12/2024 | 3/12/2026 |
| Trademark Licensing Agreement | BioKyowa, Inc. | NotApplicable_TrademarkLicensingAgreement.pdf | 8/22/2023 | 8/21/2024 |
| Organizational Chart | Kyowa Hakko Bio Co., Ltd | Organizational Chart.pdf | 8/31/2021 | 12/31/2024 |
| Pest Control Program and Policy | BioKyowa, Inc. | Pest Control Policy _ BK.pdf | 3/11/2024 | 3/11/2027 |
| CA Transparency Act | Kyowa Hakko Bio Co., Ltd | Please refer our parent company website.txt | 11/7/2022 | 11/6/2024 |
| CA Transparency Act | Kyowa Hakko USA, Inc. | Please refer our parent company website.txt | 6/29/2022 | 6/28/2024 |
| Global Quality Assessment Form | BioKyowa, Inc. | Self-Assessment_BK_20201123reviewed.pdf | 12/6/2023 | 12/5/2025 |
| Supplier/Contract Manufacturer Qualification Questionnaire | BioKyowa, Inc. | Self-Assessment_BK_20201123reviewed.pdf | 9/21/2023 | 9/20/2026 |
| SCS Supplier Assessment Questionnaire | BioKyowa, Inc. | Self-Assessment_BK_20201123reviewed.pdf | 8/22/2023 | 8/21/2024 |
| Ukraine Crisis Statement | BioKyowa, Inc. | Sensient Russia Ukraine Crisis Questionnaire V1.0 (1).pdf | 9/19/2023 | 9/18/2026 |
| Recall/Emergency/Contact List | CMIC CMO Co., Ltd. | SOP 101 Product Recall Plan_Emergency Contacts.pdf | 12/22/2021 | 12/22/2022 |
| Recall Plan | CMIC CMO Co., Ltd. | SOP 101 Product Recall Plan_Emergency Contacts.pdf | 12/22/2021 | 12/22/2022 |
| Supplier Questionnaire - Addendum | Kyowa Hakko USA, Inc. | Supplier Questionnaire - Addendum.pdf | 3/20/2024 | 3/20/2026 |
| Supplier Questionnaire | CMIC CMO Co., Ltd. | Supplier Questionnaire.pdf | 11/24/2021 | 11/24/2023 |
| Supplier Questionnaire | Sekisui Medical Co., Ltd.- Iwate Plant | Supplier Questionnaire.pdf | 9/15/2023 | 9/14/2025 |
| Supplier Questionnaire | Setria (L-Glutathione Reduced) CMO | Supplier Questionnaire.pdf | 3/12/2024 | 3/12/2026 |
| Supplier Questionnaire | BioKyowa, Inc. | Supplier Questionnaire.pdf | 9/15/2023 | 9/14/2025 |
| Supplier Questionnaire | Kyowa Hakko Bio Co., Ltd | Supplier Questionnaire.pdf | 12/6/2023 | 12/5/2025 |
| Copy of written supply chain program | CMIC CMO Co., Ltd. | Supply Chain.pdf | 9/21/2023 | 9/20/2026 |
| Sustainability (Level 1) | CMIC CMO Co., Ltd. | Sustainability (Level 1).pdf | 11/24/2021 | 11/23/2024 |
| Sustainability (Level 1) | Kyowa Hakko Bio Co., Ltd | Sustainability (Level 1).pdf | 8/31/2021 | 8/30/2024 |
| Sustainability (Level 1) | BioKyowa, Inc. | Sustainability (Level 1).pdf | 3/11/2024 | 3/11/2027 |
| Sustainability (Level 1) | Kyowa Hakko USA, Inc. | Sustainability (Level 1).pdf | 9/17/2020 | 9/17/2023 |
| Sustainability (Level 2) | Kyowa Hakko Bio Co., Ltd | Sustainability (Level 2).pdf | 8/13/2024 | 8/13/2027 |
| Sustainability (Level 2) | BioKyowa, Inc. | Sustainability (Level 2).pdf | 3/11/2024 | 3/11/2027 |