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17 Apr 2023
// HEALTH CANADA
https://www.pharmacompass.com/pdf/news/kyowa-hakko-bio-co-ltd-on-health-canada-inspection-list-9449.pdf

21 Sep 2021
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/kyowa-hakko-acclaimed-by-frost--sullivan-for-its-non-gmo-allergen-free-immune-support-paraprobiotic-ingredient-immuse-301379881.html

07 Jun 2021
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/mei-pharma-and-kyowa-kirin-announce-first-patient-with-marginal-zone-lymphoma-dosed-in-expanded-global-phase-2-tidal-study-evaluating-zandelisib-301306621.html

26 Nov 2019
// Eric Palmer FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/japan-s-kyowa-kirin-reorganizes-quality-responsibilities

17 Nov 2018
// HEALTH CANADA
https://www.pharmacompass.com/pdf/news/kyowa-hakko-bio-on-health-canada-inspection-list-1542450249.pdf

21 Sep 2018
// Ben Hirschler REUTERS
https://www.reuters.com/article/us-abbvie-biosimilars/eu-approves-fifth-copy-of-abbvies-18-billion-drug-humira-idUSKCN1M011N
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5337
Submission : 1984-04-11
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5314
Submission : 1984-04-11
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8828
Submission : 1990-11-20
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9569
Submission : 1992-03-02
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8405
Submission : 1990-01-25
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6809
Submission : 1987-02-05
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3223
Submission : 1978-06-16
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3407
Submission : 1979-01-09
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2631
Submission : 1976-03-18
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-02-05
Pay. Date : 2013-01-25
DMF Number : 3149
Submission : 1978-03-15
Status : Active
Type : II

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CEP/COS
Certificate Numbers : R1-CEP 1999-013 - Rev 02
Status : Valid
Issue Date : 2014-07-30
Type : Chemical
Substance Number : 752

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CEP/COS
Certificate Numbers : R1-CEP 1998-109 - Rev 05
Status : Valid
Issue Date : 2022-03-18
Type : Chemical
Substance Number : 806

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CEP/COS
Certificate Numbers : R1-CEP 1999-028 - Rev 04
Status : Valid
Issue Date : 2022-06-20
Type : Chemical
Substance Number : 805

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CEP/COS
Certificate Numbers : R1-CEP 1999-190 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2010-03-08
Type : Chemical
Substance Number : 797

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CEP/COS
Certificate Numbers : R1-CEP 2006-108 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-02-18
Type : Chemical
Substance Number : 761

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CEP/COS
Certificate Numbers : CEP 2003-029 - Rev 03
Status : Valid
Issue Date : 2025-02-18
Type : Chemical
Substance Number : 1311

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Certificate Numbers : CEP 2025-081 - Rev 00
Status : Valid
Issue Date : 2025-05-16
Type : Chemical
Substance Number : 1311

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CEP/COS
Certificate Numbers : R0-CEP 2014-174 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-06-09
Type : Chemical
Substance Number : 1670

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CEP/COS
Certificate Numbers : R0-CEP 2020-328 - Rev 00
Status : Valid
Issue Date : 2023-01-13
Type : Chemical
Substance Number : 1670

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CEP/COS
Certificate Numbers : R1-CEP 1999-027 - Rev 04
Status : Valid
Issue Date : 2022-05-20
Type : Chemical
Substance Number : 911

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Registration Number : 224MF10081
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2012-04-13
Latest Date of Registration : 2023-02-08

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Registration Number : 306MF10060
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2024-04-24
Latest Date of Registration : 2025-07-03

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JDMF
Registration Number : 230MF10070
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2018-06-07
Latest Date of Registration : 2018-06-07

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JDMF
Registration Number : 307MF10024
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2025-02-07
Latest Date of Registration : 2025-08-28

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Registration Number : 217MF10837
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2010-02-12

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JDMF
Registration Number : 221MF10256
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-11-30
Latest Date of Registration : 2009-11-30

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Registration Number : 222MF10009
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2010-01-07
Latest Date of Registration : 2010-01-07

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Registration Number : 229MF10036
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2017-02-08
Latest Date of Registration : 2017-02-08

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Registration Number : 217MF10117
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2005-05-24
Latest Date of Registration : 2009-04-08

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Registration Number : 218MF10946
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2006-11-24

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients
Inspections and registrations
Country : Japan
City/Region : Hofu, Yamaguchi Prefecture
Audit Date : 2026-03-26
Audit Type : On-Site
Country : Japan
City/Region : Takaoka, Toyama
Audit Date : 2025-09-19
Audit Type : On-Site
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Kyowa Hakko Bio Co., Ltd is a supplier offers 73 products (APIs, Excipients or Intermediates).
Find a price of Glutathione bulk with DMF, CEP, JDMF offered by Kyowa Hakko Bio Co., Ltd
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Find a price of L-Arginine Hydrochloride API bulk with CEP offered by Kyowa Hakko Bio Co., Ltd
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