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    As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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    LEBSA- Your strategic API source for niche molecules.

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    Inke S.A: APIs manufacturing plant.

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    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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

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    01 1Cetalkonium

    02 1Dl-Histidine Monohydrochloride Monohydrate

    03 1HEPES, Free Acid

    04 1L-Arginine

    05 1L-Arginine Hydrochloride API

    06 1L-Histidine

    07 1Mannitol

    08 1Polyethylene Glycol Excipient

    09 1QS-21

    10 1Sucrose API

    11 1Sucrose Octasulfate

    12 1Trehalose

    13 1Trehalose API

    14 2Tromethamine

    15 1Blank

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    01

    Cetalkonium

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

    AGGSpend
    Not Confirmed
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    Cetalkonium

    China

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

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    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37285

    Submission : 2022-07-01

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Dl-Histidine Monohydrochloride Mono...

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

    AGGSpend
    Not Confirmed
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    Dl-Histidine Monohydrochloride Mono...

    China

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

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    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38369

    Submission : 2023-12-27

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    L-Arginine Hydrochloride API

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

    AGGSpend
    Not Confirmed
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    L-Arginine Hydrochloride API

    China

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

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    AGGSpend
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38726

    Submission : 2024-01-15

    Status : Active

    Type : IV

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

    Polyethylene Glycol Excipient

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

    AGGSpend
    Not Confirmed
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    Polyethylene Glycol Excipient

    China

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

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    AGGSpend
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36553

    Submission : 2021-12-23

    Status : Active

    Type : IV

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

    Sucrose API

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

    AGGSpend
    Not Confirmed
    arrow

    Sucrose API

    China

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

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    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35209

    Submission : 2020-09-14

    Status : Active

    Type : IV

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

    Sucrose Octasulfate

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

    AGGSpend
    Not Confirmed
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    Sucrose Octasulfate

    China

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

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    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36552

    Submission : 2022-02-24

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Trehalose

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

    AGGSpend
    Not Confirmed
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    Trehalose

    China

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

    arrow
    AGGSpend
    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.
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34401

    Submission : 2019-12-11

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Product
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    Market
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    08

    Trehalose API

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

    AGGSpend
    Not Confirmed
    arrow

    Trehalose API

    China

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

    arrow
    AGGSpend
    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.
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35566

    Submission : 2021-01-31

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Tromethamine

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

    AGGSpend
    Not Confirmed
    arrow

    Tromethamine

    China

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

    arrow
    AGGSpend
    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.
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37604

    Submission : 2022-11-25

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Tromethamine

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

    AGGSpend
    Not Confirmed
    arrow

    Tromethamine

    China

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

    arrow
    AGGSpend
    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.
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38022

    Submission : 2023-04-11

    Status : Active

    Type : IV

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

    Product
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