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INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility
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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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11274
Submission : 1994-12-27
Status : Active
Type : II
Certificate Number : R1-CEP 2003-029 - Rev 02
Issue Date : 2022-08-09
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 :
NDC Package Code : 12079-0485
Start Marketing Date : 2010-11-05
End Marketing Date : 2024-12-31
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 : 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 : 2025-12-31
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 : 2024-12-31
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 : 2025-12-31
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 :
NDC Package Code : 12497-1003
Start Marketing Date : 1978-05-15
End Marketing Date : 2025-12-31
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 : 2170
Submission : 1973-10-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-028 - Rev 04
Issue Date : 2022-06-20
Type : Chemical
Substance Number : 805
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 : 2025-12-31
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 : 21681
Submission : 2008-06-10
Status : Active
Type : II
Registration Number : 224MF10081
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2012-04-13
Latest Date of Registration :
NDC Package Code : 12079-1067
Start Marketing Date : 2010-11-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2011-03-15
Registration Number : 5242-1-ND
Manufacturer Name : Kyowa Pharma Chemical Co., Ltd.
Manufacturer Address : 530 Chokeiji, Takaoka, Toyama 933-8511, Japan
Excipients
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15628
Submission : 2001-09-10
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11366
Submission : 1995-02-28
Status : Inactive
Type : IV
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-03-03
City : Takaokashi
State :
Country/Area : JP
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-03-03
District Decision : No Action Indicated
Inspection End Date : 2014-08-28
City : Takaokashi
State :
Country/Area : JP
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-08-28
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-01-20
City : Takaoka
State :
Country/Area : JP
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-01-20
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-01-20
City : Takaoka
State :
Country/Area : JP
Zip :
District : ORA
Center : CVM
Project Area : Monitoring of Marketed Animal Dr...
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-01-20
District Decision : Official Action Indicated
Inspection End Date : 2010-06-25
City : Hofu City
State :
Country/Area : JP
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Official Action Indicated
Inspection End Date : 2010-06-25
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-10-27
City : Hofu City
State :
Country/Area : JP
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-10-27
District Decision : No Action Indicated
Inspection End Date : 2014-03-20
City : Hofu City
State :
Country/Area : JP
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-03-20
ABOUT THIS PAGE
Kyowa Hakko Bio is a supplier offers 70 products (APIs, Excipients or Intermediates).
Find a price of Glutathione bulk with DMF, CEP, JDMF offered by Kyowa Hakko Bio
Find a price of Isoleucine bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of L-Alanine API bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of L-Arginine Hydrochloride API bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of L-Leucine API bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of Tryptophan bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of L-Histidine bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of L-Threonine bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of Lysine Acetate bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of Lysine Hydrochloride bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of Phenylalanine bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of Pravastatin bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Proline bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of Serine bulk with CEP, JDMF offered by Kyowa Hakko Bio
Find a price of Aspartic Acid API bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Citicoline Sodium bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Glycine bulk with JDMF offered by Kyowa Hakko Bio
Find a price of L-Glutamine bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Acetylpyridine Adenine Dinucleotide bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Adenine bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Adenosine 5'-Monophosphate bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Aluminium Hydroxide bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Amino Acids Mixture bulk with DMF offered by Kyowa Hakko Bio
Find a price of Calcium Aspartate bulk with JDMF offered by Kyowa Hakko Bio
Find a price of CCRIS 3941 bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Dibasic Calcium Phosphate Dihydrate bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Dl-Histidine Monohydrochloride Monohydrate bulk with JDMF offered by Kyowa Hakko Bio
Find a price of DL-Valine API bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Glutathione bulk offered by Kyowa Hakko Bio
Find a price of L-Arginine bulk with JDMF offered by Kyowa Hakko Bio
Find a price of L-Arginine Hydrochloride API bulk with CEP offered by Kyowa Hakko Bio
Find a price of L-Histidine bulk with CEP offered by Kyowa Hakko Bio
Find a price of L-Threonine bulk with JDMF offered by Kyowa Hakko Bio
Find a price of L-VALINE bulk with CEP offered by Kyowa Hakko Bio
Find a price of Magnesium Carbonate bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Magnesium Oxide bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Proline bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Serine bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Silicic Acid (H6Si2O7), Aluminum Salt (1:2) bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Kyowa Suimagu bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Oxyglutathione Kyowa bulk with JDMF offered by Kyowa Hakko Bio
Find a price of Sanarumin bulk with JDMF offered by Kyowa Hakko Bio
Find a price of 7-Cyanoquinocarcinol bulk offered by Kyowa Hakko Bio
Find a price of Acadesine bulk offered by Kyowa Hakko Bio
Find a price of Aceglutamide bulk offered by Kyowa Hakko Bio
Find a price of Aceglutamide Aluminium bulk offered by Kyowa Hakko Bio
Find a price of Adenosine bulk offered by Kyowa Hakko Bio
Find a price of Amino Acids Mixture bulk offered by Kyowa Hakko Bio
Find a price of Bucillamine bulk offered by Kyowa Hakko Bio
Find a price of Chembl2106438 bulk offered by Kyowa Hakko Bio
Find a price of D-Serine API bulk offered by Kyowa Hakko Bio
Find a price of Dacarbazine bulk offered by Kyowa Hakko Bio
Find a price of Dopamine bulk offered by Kyowa Hakko Bio
Find a price of Fostriecin bulk offered by Kyowa Hakko Bio
Find a price of L-Cysteine Hydrochloride bulk offered by Kyowa Hakko Bio
Find a price of L-Malic Acid bulk offered by Kyowa Hakko Bio
Find a price of Minocycline Hydrochloride bulk offered by Kyowa Hakko Bio
Find a price of Mitomycin bulk offered by Kyowa Hakko Bio
Find a price of Sodium Hyaluronate bulk offered by Kyowa Hakko Bio
Find a price of Taurine bulk offered by Kyowa Hakko Bio
Find a price of Ubidecarenone bulk offered by Kyowa Hakko Bio
Find a price of Uracil Mustard bulk offered by Kyowa Hakko Bio
Find a price of FACILITIES AND PROCEDURES IN SHIZUOKA PREFECTURE, JAPAN bulk offered by Kyowa Hakko Bio
Find a price of FACILITIES & CONTROLS (UBE PLANT IN JAPAN) bulk offered by Kyowa Hakko Bio
Find a price of L-ASPARAGINASE bulk offered by Kyowa Hakko Bio
Find a price of AMINO ACIDS--GENERAL INFO ON BULK DRUG SUBSTANCES bulk offered by Kyowa Hakko Bio
Find a price of PEGYLATED GRANULOCYTE COLONY-STIMULATING FACTOR MUTEIN BULK SUBSTANCE bulk offered by Kyowa Hakko Bio
Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ASHIKAGA-SHI, JAPAN. bulk offered by Kyowa Hakko Bio
Find a price of L-CYSTINE AND L-CYSTINE MONOHYDROCHLORIDE bulk offered by Kyowa Hakko Bio
Find a price of L-GLUTATHIONE REDUCED (ORAL GRADE) bulk offered by Kyowa Hakko Bio
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