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    01 17-Cyanoquinocarcinol

    02 1Acadesine

    03 1Aceglutamide

    04 1Aceglutamide Aluminium

    05 1Acetylcysteine

    06 1Acetylpyridine Adenine Dinucleotide

    07 1Adenine

    08 3Adenosine

    09 2Adenosine 5'-Monophosphate

    10 1Alprostadil Alfadex

    11 5Aluminium Hydroxide

    12 5Amino Acids Mixture

    13 1Aspartic Acid API

    14 1Benidipine Hydrochloride

    15 1Benzamidine

    16 1Bimatoprost

    17 1Bucillamine

    18 1Calcium Aspartate

    19 1Cetraxate

    20 1Chembl2106438

    21 2Citicoline Sodium

    22 1D-Panthenol

    23 1D-Serine API

    24 1DL-Valine API

    25 2Dacarbazine

    26 1Dibasic Calcium Phosphate Dihydrate

    27 2Dinoprostone

    28 1Dl-Histidine Monohydrochloride Monohydrate

    29 2Dopamine

    30 1Fostriecin

    31 2Glutathione

    32 1Glycine

    33 1Isoleucine

    34 1Istradefylline

    35 1L-Alanine API

    36 1L-Arginine

    37 2L-Arginine Hydrochloride API

    38 1L-Cysteine Hydrochloride

    39 1L-Glutamic Acid

    40 1L-Glutamine

    41 2L-Histidine

    42 1L-Leucine API

    43 1L-Malic Acid

    44 2L-Threonine

    45 1L-VALINE

    46 1Latanoprost

    47 1Lubiprostone

    48 1Lysine Acetate

    49 1Lysine Hydrochloride

    50 2Magnesium Carbonate

    51 8Magnesium Oxide

    52 1Methionine

    53 2Minocycline Hydrochloride

    54 2Misoprostol

    55 1Mitomycin

    56 2Olopatadine Hydrochloride

    57 1Oxoiron

    58 1Phenylalanine

    59 1Pilsicainide Hydrochloride

    60 1Pravastatin

    61 2Proline

    62 1Riboflavin

    63 1Sepetaprost

    64 2Serine

    65 2Silicic Acid (H6Si2O7), Aluminum Salt (1:2)

    66 2Sodium Hyaluronate

    67 1Sodium Valproate

    68 1Sulfadimethoxine

    69 1Sulfadimethoxine Sodium

    70 1Taurine

    71 1Tranexamic Acid

    72 1Tryptophan

    73 1Ubidecarenone

    74 1Uracil Mustard

    75 1Valsartan

    76 14Blank

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    01

    Dinoprostone

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

    RDD
    Not Confirmed
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    Dinoprostone

    Japan

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

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    RDD
    Not Confirmed
    • fda
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    USDMF arrow-down Click Us! arrow-down
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    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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    02

    Dinoprostone

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

    RDD
    Not Confirmed
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    Dinoprostone

    Japan

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

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    RDD
    Not Confirmed
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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 :

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    03

    Glutathione

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

    RDD
    Not Confirmed
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    Glutathione

    Japan

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

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    RDD
    Not Confirmed
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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 ...

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    04

    Latanoprost

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

    RDD
    Not Confirmed
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    Latanoprost

    Japan

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

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    RDD
    Not Confirmed
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    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 :

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    05

    Tranexamic Acid

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

    RDD
    Not Confirmed
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    Tranexamic Acid

    Japan

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

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    RDD
    Not Confirmed
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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

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    06

    Isoleucine

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

    RDD
    Not Confirmed
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    Isoleucine

    Japan

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

    arrow
    RDD
    Not Confirmed
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    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 ...

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    07

    L-Alanine API

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

    RDD
    Not Confirmed
    arrow

    L-Alanine API

    Japan

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
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    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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    08

    L-Arginine Hydrochloride API

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

    RDD
    Not Confirmed
    arrow

    L-Arginine Hydrochloride API

    Japan

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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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    09

    L-Leucine API

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

    RDD
    Not Confirmed
    arrow

    L-Leucine API

    Japan

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

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    RDD
    Not Confirmed
    • fda
    • EDQM
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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 :

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    10

    Tryptophan

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

    RDD
    Not Confirmed
    arrow

    Tryptophan

    Japan

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

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    RDD
    Not Confirmed
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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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    Contact Kyowa Hakko Bio and get a quotation

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

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