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    Company profile for Kyowa Hakko Bio

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    EVENTS

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    About

    Kyowa Hakko Bio is a Japanese leading company of bio-technology and fermentation. We are utilizing the world's top-level fermentation and synthesis technologies to supply domestic and overseas users with various fine chemical products centered on amino and nucleic acids for pharmaceuticals, nutritional supplements, and industrial use, as well as the derivatives of such acids. Through the rapid progress in genome analysis see...
    Kyowa Hakko Bio is a Japanese leading company of bio-technology and fermentation. We are utilizing the world's top-level fermentation and synthesis technologies to supply domestic and overseas users with various fine chemical products centered on amino and nucleic acids for pharmaceuticals, nutritional supplements, and industrial use, as well as the derivatives of such acids. Through the rapid progress in genome analysis seen in recent years, we anticipate the development of new biotechnology processes and products from fermentation, a technology which humankind has been utilizing since time immemorial.

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    CONTACT DETAILS

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    Kyowa Hakko Biojapan Flag
    Country
    Country
    Japan
    Address
    Address
    Ohtemachi Building, 1-6-1,Ohtemachi,Chiyoda-ku, Tokyo, 100-8185, Japan
    Telephone
    Telephone
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.kyowahakko-bio.co.jp/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Events

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    BPI Europe

    BPI Europe

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    Digital content

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    NEWS #PharmaBuzz

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    Kyowa Hakko Bio Co., Ltd. on Health Canada Inspection List
    Kyowa Hakko Bio Co., Ltd. on Health Canada Inspection List

    17 Apr 2023

    // HEALTH CANADA

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

    HEALTH CANADA
    17 Apr 2023
    Share Share
    Kyowa Hakko Acclaimed by Frost & Sullivan for its IMMUSE
    Kyowa Hakko Acclaimed by Frost & Sullivan for its IMMUSE

    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

    PRNEWSWIRE
    21 Sep 2021
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    MEI Pharma & Kyowa Kirin Announce 1st Patient with Marginal Zone Lymphoma Dosed
    MEI Pharma & Kyowa Kirin Announce 1st Patient with Marginal Zone Lymphoma Dosed

    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

    PRNEWSWIRE
    07 Jun 2021
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    Japan's Kyowa Kirin reorganizes quality responsibilities
    Japan's Kyowa Kirin reorganizes quality responsibilities

    26 Nov 2019

    // Eric Palmer FIERCE PHARMA

    https://www.fiercepharma.com/manufacturing/japan-s-kyowa-kirin-reorganizes-quality-responsibilities

    Eric Palmer FIERCE PHARMA
    26 Nov 2019
    Share Share
    Kyowa Hakko Bio on Health Canada Inspection List
    Kyowa Hakko Bio on Health Canada Inspection List

    17 Nov 2018

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/kyowa-hakko-bio-on-health-canada-inspection-list-1542450249.pdf

    HEALTH CANADA
    17 Nov 2018
    Share Share
    EU approves fifth copy of AbbVie's $18 billion drug Humira
    EU approves fifth copy of AbbVie's $18 billion drug Humira

    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

    Ben Hirschler REUTERS
    21 Sep 2018
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    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Dinoprostone

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    Dinoprostone

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11274

    Submission : 1994-12-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2025-081 - Rev 00

    Issue Date : 2025-05-16

    Type : Chemical

    Substance Number : 1311

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 307MF10024

    Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture

    Initial Date of Registration : 2025-02-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    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

    KDMF VMF Others AUDIT arrow-down
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    Product
    Web Link

    Stock Recap
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    Market
    Place

    02

    Dinoprostone

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    Dinoprostone

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41392

    Submission : 2025-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2003-029 - Rev 03

    Issue Date : 2025-02-18

    Type : Chemical

    Substance Number : 1311

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10070

    Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture

    Initial Date of Registration : 2018-06-07

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Glutathione

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    Glutathione

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7799

    Submission : 1988-12-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-328 - Rev 00

    Issue Date : 2023-01-13

    Type : Chemical

    Substance Number : 1670

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10240

    Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo

    Initial Date of Registration : 2005-06-15

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    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 ...

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
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    Market
    Place

    04

    Latanoprost

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    Latanoprost

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32989

    Submission : 2018-08-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-107 - Rev 01

    Issue Date : 2024-01-29

    Type : Chemical

    Substance Number : 2230

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10069

    Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture

    Initial Date of Registration : 2008-02-25

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Product
    Web Link

    Stock Recap
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    Market
    Place

    05

    Tranexamic Acid

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    Tranexamic Acid

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    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

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-271 - Rev 02

    Issue Date : 2022-09-14

    Type : Chemical

    Substance Number : 875

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 224MF10082

    Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture

    Initial Date of Registration : 2012-04-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    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

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Isoleucine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    Isoleucine

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 2623

    Submission : 1976-02-11

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-014 - Rev 04

    Issue Date : 2020-08-14

    Type : Chemical

    Substance Number : 770

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10221

    Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo

    Initial Date of Registration : 2005-06-15

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    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 ...

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    L-Alanine API

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    L-Alanine API

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 2621

    Submission : 1976-03-02

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-013 - Rev 02

    Issue Date : 2014-07-30

    Type : Chemical

    Substance Number : 752

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10247

    Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo

    Initial Date of Registration : 2010-10-28

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Product
    Web Link

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    Market
    Place

    08

    L-Arginine Hydrochloride API

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    L-Arginine Hydrochloride API

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 2170

    Submission : 1973-10-24

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-028 - Rev 04

    Issue Date : 2022-06-20

    Type : Chemical

    Substance Number : 805

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10190

    Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo

    Initial Date of Registration : 2007-06-08

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Product
    Web Link

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    Market
    Place

    09

    L-Leucine API

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    L-Leucine API

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 2622

    Submission : 1976-02-04

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-160 - Rev 03

    Issue Date : 2013-08-30

    Type : Chemical

    Substance Number : 771

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10235

    Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo

    Initial Date of Registration : 2005-06-15

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Product
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    Market
    Place

    10

    Tryptophan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Bioprocess International Europe
    Not Confirmed
    arrow

    Tryptophan

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 2247

    Submission : 1974-03-12

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-189 - Rev 03

    Issue Date : 2022-12-05

    Type : Chemical

    Substance Number : 1272

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10228

    Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo

    Initial Date of Registration : 2005-06-15

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    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 ...

    KDMF VMF Others AUDIT arrow-down
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    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    USDMF

    read-more
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    01

    Aceglutamide Aluminum

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    02

    Aceglutamide Aluminum Granules (kw-1...

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    03

    Adenosine

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    04

    Adenosine Triphosphate Disodium

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    05

    Aica-riboside

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    06

    Alpha-mercaptopropionylglycine

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    07

    Amino Acid Blend "kyowa",type Tr-1

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    08

    Amino Acid Mixtures

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    09

    Amino Acids

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    10

    Amino Acids

    Japan
    Stanford Drug Discovery Symposium
    Not Confirmed
    arrow

    Amino Acids

    Japan
    arrow
    Stanford Drug Discovery Symposium
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Kyowa Hakko Bio

    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

    blank

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    Market
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    Excipients

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    ABOUT THIS PAGE

    Contact Kyowa Hakko Bio and get a quotation

    Kyowa Hakko Bio is a supplier offers 72 products (APIs, Excipients or Intermediates).

    Find Glutathione bulk with DMF, CEP, JDMF offered by Kyowa Hakko Bio

    Find Isoleucine bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find L-Alanine API bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find L-Arginine Hydrochloride API bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find L-Leucine API bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find Tryptophan bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find L-Histidine bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find L-Threonine bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find Lysine Acetate bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find Lysine Hydrochloride bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find Phenylalanine bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find Pravastatin bulk with JDMF offered by Kyowa Hakko Bio

    Find Proline bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find Serine bulk with CEP, JDMF offered by Kyowa Hakko Bio

    Find Aspartic Acid API bulk with JDMF offered by Kyowa Hakko Bio

    Find Citicoline Sodium bulk with JDMF offered by Kyowa Hakko Bio

    Find Glycine bulk with JDMF offered by Kyowa Hakko Bio

    Find L-Glutamine bulk with JDMF offered by Kyowa Hakko Bio

    Find Acetylpyridine Adenine Dinucleotide bulk with JDMF offered by Kyowa Hakko Bio

    Find Adenine bulk with JDMF offered by Kyowa Hakko Bio

    Find Adenosine 5'-Monophosphate bulk with JDMF offered by Kyowa Hakko Bio

    Find Aluminium Hydroxide bulk with JDMF offered by Kyowa Hakko Bio

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