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    Company profile for Clarochem Ireland

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    Clarochem Ireland, established in 2009 following the acquisition of a state-of-the-art facility in Damastown near Dublin, offers approximately 60,000L of manufacturing capacity. Gaining its first US FDA approval in 2017, the site is well-positioned for contract manufacturing opportunities. With ample room for expansion, it plays a strategic role in the group’s back-integration of GMP starting materials and intermediates, enhancing efficiency and value across all affiliated companies.

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    Clarochem IrelandIreland Flag
    Country
    Country
    Ireland
    Address
    Address
    Damastown, Mulhuddart, Dublin 15
    Telephone
    Telephone
    +39 023925326
    Client Email
    Email
    sales@cosma.it
    Client Website
    Website
    https://www.cfm-group.it/cosma/
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    Linkedin
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    YouTube
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    Twitter
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    ALL APIs

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    01

    Droxidopa

    Ireland

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

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    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-03-20

    Pay. Date : 2019-01-31

    DMF Number : 33459

    Submission : 2019-01-04

    Status : Active

    Type : II

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

    NDC Package Code : 76278-1120

    Start Marketing Date : 2016-11-25

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

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    Available Reg. Filing : ASMF
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    02

    Fosfomycin Trometamol

    Ireland

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-327 - Rev 01

    Issue Date : 2025-09-15

    Type : Chemical

    Substance Number : 1425

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 76278-1700

    Start Marketing Date : 2025-03-31

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Levodropropizine

    Ireland

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

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    Certificate Number : R1-CEP 2012-083 - Rev 01

    Issue Date : 2020-01-17

    Type : Chemical

    Substance Number : 1535

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Sampung Finechem Co., Ltd.

    Registration Date : 2022-11-15

    Registration Number : 20131029-137-H-241-10(4)

    Manufacturer Name : Clarochem Ireland Ltd.

    Manufacturer Address : Damastown, Mulhuddart, Dublin 15, Ireland

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    04

    Dexketoprofen Trometamol

    Ireland

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

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    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
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    05

    Ketoprofen Lysinate

    Ireland

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

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    • fda
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    Available Reg. Filing : ASMF
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    06

    Levodropropizine

    Ireland

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

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

    Registrant Name : Goodwills Co., Ltd.

    Registration Date : 2013-10-29

    Registration Number : 20131029-137-H-241-10

    Manufacturer Name : Clarochem Ireland Ltd.

    Manufacturer Address : Damastown, Mulhuddart, Dublin 15, Ireland

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    07

    Levodropropizine

    Ireland

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

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    ✖

    Registrant Name : Hyundai Pharmaceutical Co., Ltd.

    Registration Date : 2015-09-09

    Registration Number : 20131029-137-H-241-10(3)

    Manufacturer Name : Clarochem Ireland Ltd.

    Manufacturer Address : Damastown, Mulhuddart, Dublin 15, Ireland

     VMF Others AUDIT arrow-down
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    08

    Levodropropizine

    Ireland

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

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    ✖

    Registrant Name : Pharmaking Co., Ltd.

    Registration Date : 2015-05-22

    Registration Number : 20131029-137-H-241-10(2)

    Manufacturer Name : Clarochem Ireland Ltd.

    Manufacturer Address : Damastown, Mulhuddart, Dublin 15, Ireland

     VMF Others AUDIT arrow-down
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    09

    Levodropropizine

    Ireland

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

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    PEGS Boston Summit
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    • fda
    • EDQM
    • WHO-GMP
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    ✖

    Registrant Name : Good Pharma Co., Ltd.

    Registration Date : 2013-12-30

    Registration Number : 20131029-137-H-241-10(1)

    Manufacturer Name : Clarochem Ireland Ltd.

    Manufacturer Address : Damastown, Mulhuddart, Dublin 15, Ireland

     VMF Others AUDIT arrow-down
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    10

    Rifaximin

    Ireland

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

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    PEGS Boston Summit
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    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 76278-1109

    Start Marketing Date : 2013-11-18

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
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    ABOUT THIS PAGE

    Contact Clarochem Ireland and get a quotation

    Clarochem Ireland is a supplier offers 7 products (APIs, Excipients or Intermediates).

    Find Droxidopa bulk with DMF offered by Clarochem Ireland

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    Find Ketoprofen Lysinate bulk offered by Clarochem Ireland

    Find Levodropropizine bulk offered by Clarochem Ireland

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