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    Cholic Acid

    ACTIVE PHARMA INGREDIENTS

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    01 2Mirum Pharmaceuticals

    02 4Theravia

    03 2Travere Therapeutics

    04 4World Medicine

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    01

    Mirum Pharmaceuticals

    U.S.A
    FNCE
    Not Confirmed
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    Mirum Pharmaceuticals

    U.S.A
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    FNCE
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : RX

    Registration Country : USA

    CHOLIC ACID

    Brand Name : CHOLBAM

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 50MG

    Packaging :

    Approval Date : 2015-03-17

    Application Number : 205750

    Regulatory Info : RX

    Registration Country : USA

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    02

    Mirum Pharmaceuticals

    U.S.A
    FNCE
    Not Confirmed
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    Mirum Pharmaceuticals

    U.S.A
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    FNCE
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : RX

    Registration Country : USA

    CHOLIC ACID

    Brand Name : CHOLBAM

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2015-03-17

    Application Number : 205750

    Regulatory Info : RX

    Registration Country : USA

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    03

    Theravia

    France
    FNCE
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    Theravia

    France
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    FNCE
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    Regulatory Info : Approved

    Registration Country : Sweden

    Cholsyra

    Brand Name : Orphacol

    Dosage Form : Capsule

    Dosage Strength : 250mg

    Packaging :

    Approval Date : 12/09/2013

    Application Number : 20100115000026

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    Theravia

    France
    FNCE
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    Theravia

    France
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    FNCE
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    Regulatory Info : Approved

    Registration Country : Sweden

    Cholsyra

    Brand Name : Orphacol

    Dosage Form : Capsule

    Dosage Strength : 50mg

    Packaging :

    Approval Date : 12/09/2013

    Application Number : 20100115000019

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    Theravia

    France
    FNCE
    Not Confirmed
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    Theravia

    France
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    FNCE
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    Regulatory Info : Authorized

    Registration Country : Spain

    Acid Cholic

    Brand Name : Orphacol

    Dosage Form : Hard Capsule

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2015-01-15

    Application Number : 113870004

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Theravia

    France
    FNCE
    Not Confirmed
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    Theravia

    France
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    FNCE
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    Regulatory Info : Authorized

    Registration Country : Spain

    Acid Cholic

    Brand Name : Orphacol

    Dosage Form : Hard Capsule

    Dosage Strength : 50MG

    Packaging :

    Approval Date : 2015-01-15

    Application Number : 113870001

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Travere Therapeutics

    U.S.A
    FNCE
    Not Confirmed
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    Travere Therapeutics

    U.S.A
    arrow
    FNCE
    Not Confirmed
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    • EDQM
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    Flag U.S.A
    Virtual Booth Virtual Booth
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Cholsyra

    Brand Name : Kolbam

    Dosage Form : Capsule

    Dosage Strength : 250mg

    Packaging :

    Approval Date : 04/04/2014

    Application Number : 20120406000047

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    08

    Travere Therapeutics

    U.S.A
    FNCE
    Not Confirmed
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    Travere Therapeutics

    U.S.A
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    FNCE
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    • fda
    • EDQM
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Cholsyra

    Brand Name : Kolbam

    Dosage Form : Capsule

    Dosage Strength : 50mg

    Packaging :

    Approval Date : 04/04/2014

    Application Number : 20120406000030

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    09

    World Medicine

    Turkey
    FNCE
    Not Confirmed
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    World Medicine

    Turkey
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    FNCE
    Not Confirmed
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    Regulatory Info :

    Registration Country : Turkey

    Cholic Acid

    Brand Name : CHOLUDEXAN

    Dosage Form : SUSPENSION

    Dosage Strength : 250MG/5ML

    Packaging : 100 ML OR 250 ML/BOTTLE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Turkey

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    10

    World Medicine

    Turkey
    FNCE
    Not Confirmed
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    World Medicine

    Turkey
    arrow
    FNCE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Turkey

    Cholic Acid

    Brand Name : CHOLUDEXAN

    Dosage Form : CAPSULE

    Dosage Strength : 150MG

    Packaging : 10 OR 20 OR 50 OR 100 CAPSULES

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Turkey

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    11

    World Medicine

    Turkey
    FNCE
    Not Confirmed
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    World Medicine

    Turkey
    arrow
    FNCE
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info :

    Registration Country : Turkey

    Cholic Acid

    Brand Name : CHOLUDEXAN

    Dosage Form : CAPSULE

    Dosage Strength : 250MG

    Packaging : 10 OR 20 OR 50 OR 100 CAPSULES

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Turkey

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    12

    World Medicine

    Turkey
    FNCE
    Not Confirmed
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    World Medicine

    Turkey
    arrow
    FNCE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Turkey

    Cholic Acid

    Brand Name : CHOLUDEXAN

    Dosage Form : CAPSULE

    Dosage Strength : 300MG

    Packaging : 10 OR 20 OR 50 OR 100 CAPSULES

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Turkey

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