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BIO International Conv...BIO International Convention
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22-25 June, 2026
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25-28 June, 2026
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29 June-02 July, 2026
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Events
Webinars & Exhibitions
BIO International Convention
Not Confirmed
Contact SupplierBIO International Convention
BIO International Conv...BIO International Convention
Industry Trade Show
Not Confirmed
22-25 June, 2026
The Aesthetic ShowThe Aesthetic Show
Industry Trade Show
Not Confirmed
25-28 June, 2026
Industry Trade Show
Not Confirmed
29 June-02 July, 2026
Digital content
NEWS #PharmaBuzz
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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11274
Submission : 1994-12-27
Status : Active
Type : II
Certificate Number : CEP 2025-081 - Rev 00
Issue Date : 2025-05-16
Type : Chemical
Substance Number : 1311
Status : Valid
Registration Number : 307MF10024
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2025-02-07
Latest Date of Registration :
NDC Package Code : 12079-0485
Start Marketing Date : 2010-11-05
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41392
Submission : 2025-03-31
Status : Active
Type : II
Certificate Number : CEP 2003-029 - Rev 03
Issue Date : 2025-02-18
Type : Chemical
Substance Number : 1311
Status : Valid
Registration Number : 230MF10070
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2018-06-07
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7799
Submission : 1988-12-02
Status : Active
Type : II
Certificate Number : R0-CEP 2020-328 - Rev 00
Issue Date : 2023-01-13
Type : Chemical
Substance Number : 1670
Status : Valid
Registration Number : 217MF10240
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration :
NDC Package Code : 12497-1054
Start Marketing Date : 1988-12-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR ...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32989
Submission : 2018-08-07
Status : Active
Type : II
Certificate Number : CEP 2022-107 - Rev 01
Issue Date : 2024-01-29
Type : Chemical
Substance Number : 2230
Status : Valid
Registration Number : 220MF10069
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2008-02-25
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-27
Pay. Date : 2016-05-23
DMF Number : 26128
Submission : 2012-06-05
Status : Active
Type : II
Certificate Number : R1-CEP 2012-271 - Rev 02
Issue Date : 2022-09-14
Type : Chemical
Substance Number : 875
Status : Valid
Registration Number : 224MF10082
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2012-04-13
Latest Date of Registration :
NDC Package Code : 12079-2001
Start Marketing Date : 2011-10-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2623
Submission : 1976-02-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-014 - Rev 04
Issue Date : 2020-08-14
Type : Chemical
Substance Number : 770
Status : Valid
Registration Number : 217MF10221
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration :
NDC Package Code : 12497-1008
Start Marketing Date : 1978-03-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR ...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2621
Submission : 1976-03-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-013 - Rev 02
Issue Date : 2014-07-30
Type : Chemical
Substance Number : 752
Status : Valid
Registration Number : 222MF10247
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2010-10-28
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2170
Submission : 1973-10-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-109 - Rev 05
Issue Date : 2022-03-18
Type : Chemical
Substance Number : 806
Status : Valid
Registration Number : 219MF10190
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2007-06-08
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2622
Submission : 1976-02-04
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-160 - Rev 03
Issue Date : 2013-08-30
Type : Chemical
Substance Number : 771
Status : Valid
Registration Number : 217MF10235
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2247
Submission : 1974-03-12
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-189 - Rev 03
Issue Date : 2022-12-05
Type : Chemical
Substance Number : 1272
Status : Valid
Registration Number : 217MF10228
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration :
NDC Package Code : 12497-1019
Start Marketing Date : 1978-03-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients
Inspections and registrations
GDUFA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]THIRD-PARTY AUDIT
Country : Japan
City/Region : Yamaguchi
Audit Date : 2026-03-26
Audit Type : On-Site
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Kyowa Hakko Bio Co Ltd is a supplier offers 72 products (APIs, Excipients or Intermediates).
Find Glutathione bulk with DMF, CEP, JDMF offered by Kyowa Hakko Bio Co Ltd
Find Isoleucine bulk with CEP, JDMF offered by Kyowa Hakko Bio Co Ltd
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Find Adenosine 5'-Monophosphate bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Aluminium Hydroxide bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Amino Acids Mixture bulk with DMF offered by Kyowa Hakko Bio Co Ltd
Find Calcium Aspartate bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Dibasic Calcium Phosphate Dihydrate bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Dl-Histidine Monohydrochloride Monohydrate bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find DL-Valine API bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Glutathione bulk offered by Kyowa Hakko Bio Co Ltd
Find L-Arginine bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find L-Arginine Hydrochloride API bulk with CEP offered by Kyowa Hakko Bio Co Ltd
Find L-Histidine bulk with CEP offered by Kyowa Hakko Bio Co Ltd
Find L-Threonine bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find L-VALINE bulk with CEP offered by Kyowa Hakko Bio Co Ltd
Find Magnesium Carbonate bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Magnesium Oxide bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Proline bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Serine bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Silicic Acid (H6Si2O7), Aluminum Salt (1:2) bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Sanarumin bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
Find Kyowa Suimagu bulk with JDMF offered by Kyowa Hakko Bio Co Ltd
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Find Acadesine bulk offered by Kyowa Hakko Bio Co Ltd
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Find Bucillamine bulk offered by Kyowa Hakko Bio Co Ltd
Find Chembl2106438 bulk offered by Kyowa Hakko Bio Co Ltd
Find D-Serine API bulk offered by Kyowa Hakko Bio Co Ltd
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Find Dopamine bulk offered by Kyowa Hakko Bio Co Ltd
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Find L-Malic Acid bulk offered by Kyowa Hakko Bio Co Ltd
Find Minocycline Hydrochloride bulk offered by Kyowa Hakko Bio Co Ltd
Find Mitomycin bulk offered by Kyowa Hakko Bio Co Ltd
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Find L-GLUTATHIONE REDUCED (ORAL GRADE) bulk offered by Kyowa Hakko Bio Co Ltd
Find MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ASHIKAGA-SHI, JAPAN. bulk offered by Kyowa Hakko Bio Co Ltd
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Find FACILITIES & CONTROLS (UBE PLANT IN JAPAN) bulk offered by Kyowa Hakko Bio Co Ltd
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Find PEGYLATED GRANULOCYTE COLONY-STIMULATING FACTOR MUTEIN BULK SUBSTANCE bulk offered by Kyowa Hakko Bio Co Ltd
Find Acetylcysteine bulk offered by Kyowa Hakko Bio Co Ltd
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Find Methionine bulk offered by Kyowa Hakko Bio Co Ltd
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