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    List of all Manufacturers, Suppliers & Exporters of Difelikefalin API listed on PharmaCompass with details of regulatory filings

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    Bora Pharmaceuticals- Making success more certain.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Difelikefalin

    ACTIVE PHARMA INGREDIENTS

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    01 1Neuland Laboratories

    02 1Chunghwa Chemical Synthesis & Biotech

    03 1Aspen API

    04 1Omgene Life Sciences Pvt. Ltd

    05 1ALP Pharm

    06 1Cipla

    07 1PolyPeptide Group

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    01

    Neuland Laboratories

    India

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

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    CPhI Worldwide, Milan
    Booth #1A18
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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

    Portfolio PDF

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    Virtual Booth

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    Corporate PDF

    02

    Chunghwa Chemical Synthesis & Biot...

    Taiwan

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

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    CPhI Worldwide, Milan
    Booth #3A86
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38511

    Submission : 2023-06-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6273

    Start Marketing Date : 2021-12-14

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    CCSB Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Aspen API

    Netherlands

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

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    CPhI Worldwide, Milan
    Booth #5C41
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Aspen API Comapny Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    04

    Omgene Life Sciences Pvt. Ltd

    India

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

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    CPhI Worldwide, Milan
    Booth #4B121
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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    Omgene Company Banner

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    Website

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    05

    ALP Pharm

    China

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

    Discovery on Target
    Not Confirmed
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    ALP Pharm

    China

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

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    Discovery on Target
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38645

    Submission : 2023-08-02

    Status : Active

    Type : II

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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    06

    Cipla

    India

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

    Discovery on Target
    Not Confirmed
    arrow

    Cipla

    India

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

    arrow
    Discovery on Target
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37712

    Submission : 2023-01-25

    Status : Active

    Type : II

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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    07

    PolyPeptide Group

    Switzerland

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

    Discovery on Target
    Not Confirmed
    arrow

    PolyPeptide Group

    Switzerland

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

    arrow
    Discovery on Target
    Not Confirmed
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 304MF10128

    Registrant's Address : 7 rue de Boulogne 67100 Strasbourg, France

    Initial Date of Registration : 2022-09-08

    Latest Date of Registration : --

     EU-WC NDC arrow-down
    ✖

    NDC Package Code : 59162-0002

    Start Marketing Date : 2021-01-08

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    Difelikefalin Manufacturers | Traders | Suppliers

    Difelikefalin Manufacturers, Traders, Suppliers 1
    31

    We have 7 companies offering Difelikefalin

    Get in contact with the supplier of your choice:

    1. Aspen API
    2. Neuland Laboratories
    3. Chunghwa Chemical Synthesis & Biotech
    4. Omgene Life Sciences Pvt. Ltd
    5. ALP Pharm
    6. Cipla
    7. PolyPeptide Group