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    FAMAR CDMO- From early development to commercial manufacturing.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    AbbVie Contract Manufacturing partners globally to develop, scale, and manufacture pharmaceutical products successfully.

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    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Ajinomoto Company

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    01 1Dl-Histidine Monohydrochloride Monohydrate

    02 1L-Arginine

    03 1L-Arginine Hydrochloride

    04 1L-Arginine Hydrochloride API

    05 1L-Aspartic Acid

    06 1L-Histidine

    07 2L-Leucine

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    01

    L-Arginine Hydrochloride API

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

    PEGS Boston Summit
    Not Confirmed
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    L-Arginine Hydrochloride API

    Japan

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

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    PEGS Boston Summit
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39436

    Submission : 2024-04-30

    Status : Active

    Type : IV

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-189 - Rev 00

    Issue Date : 2022-09-28

    Type :

    Substance Number :

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    L-Histidine

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

    PEGS Boston Summit
    Not Confirmed
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    L-Histidine

    Japan

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

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    PEGS Boston Summit
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39330

    Submission : 2024-04-30

    Status : Active

    Type : IV

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 1998-107 - Rev 04

    Issue Date : 2018-06-22

    Type :

    Substance Number :

    Status : Valid

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    NDC Package Code : 51495-916

    Start Marketing Date : 2022-10-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    03

    Dl-Histidine Monohydrochloride Mono...

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

    PEGS Boston Summit
    Not Confirmed
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    Dl-Histidine Monohydrochloride Mono...

    Japan

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

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    PEGS Boston Summit
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39435

    Submission : 2024-04-30

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    L-Arginine

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

    PEGS Boston Summit
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    L-Arginine

    Japan

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

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    PEGS Boston Summit
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39434

    Submission : 2024-04-30

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    ADVANTAME

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

    PEGS Boston Summit
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    ADVANTAME

    Japan

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

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    PEGS Boston Summit
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28509

    Submission : 2014-07-28

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    L-Arginine Hydrochloride

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

    PEGS Boston Summit
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    L-Arginine Hydrochloride

    Japan

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

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    PEGS Boston Summit
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    Registrant Name : Bigsol Bio Co., Ltd.

    Registration Date : 2025-08-25

    Registration Number : 20250825-210-J-1993

    Manufacturer Name : Shanghai Ajinomoto Amino Acid Co., Ltd.

    Manufacturer Address : No. 718 East Rongle Road, Songjiang District, Shanghai 201613, China

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    07

    L-Aspartic Acid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    L-Aspartic Acid

    Japan

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

    arrow
    PEGS Boston Summit
    Not Confirmed
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    NDC Package Code : 17333-005

    Start Marketing Date : 2002-06-28

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    L-Leucine

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    L-Leucine

    Japan

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

    arrow
    PEGS Boston Summit
    Not Confirmed
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    NDC Package Code : 72013-922

    Start Marketing Date : 2008-06-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    L-Leucine

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    L-Leucine

    Japan

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

    arrow
    PEGS Boston Summit
    Not Confirmed
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    ✖

    NDC Package Code : 51495-822

    Start Marketing Date : 2022-10-01

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Contact Ajinomoto Company and get a quotation

    Ajinomoto Company is a supplier offers 98 products (APIs, Excipients or Intermediates).

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