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    Approved Marketing Authorisations (MA) containing Mitomycin in Europe. Original Data : EMA Website

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

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    Mitomycin

    ACTIVE PHARMA INGREDIENTS

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    01 2KYOWA KIRIN LIMITED

    02 1Leman SKL SA

    03 1Medac - Gesellschaft für klinische Spezialpräparate Gmbh - Wedel

    04 1Mylan Hospital AS

    05 2Speciality European Pharma Ltd,

    06 2medac Gesellschaft für

    07 2medac GmbH,

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    01

    KYOWA KIRIN LIMITED

    Japan
    Discovery on Target
    Not Confirmed
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    KYOWA KIRIN LIMITED

    Japan
    arrow
    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Italy

    Mitomycin

    Brand Name : Mitomycin C

    Dosage Form : Mitomycin 10Mg 1 Unit Parenteral Use

    Dosage Strength : 1 vial EV 10 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    KYOWA KIRIN LIMITED

    Japan
    Discovery on Target
    Not Confirmed
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    KYOWA KIRIN LIMITED

    Japan
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    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Italy

    Mitomycin

    Brand Name : Mitomycin C

    Dosage Form : Mitomycin 40Mg 1 Unit Parenteral Use

    Dosage Strength : 1 vial EV 40 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    03

    medac GmbH,

    Germany
    Discovery on Target
    Not Confirmed
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    Germany
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    Regulatory Info :

    Registration Country : Sweden

    mitomycin

    Brand Name : Mitomycin medac

    Dosage Form : PULVER OCH VÄTSKA TILL INTRAVESIKAL LÖSNING

    Dosage Strength : 20 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    04

    medac GmbH,

    Germany
    Discovery on Target
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    Germany
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    Regulatory Info :

    Registration Country : Sweden

    mitomycin

    Brand Name : Mitomycin medac

    Dosage Form : PULVER OCH VÄTSKA TILL INTRAVESIKAL LÖSNING

    Dosage Strength : 40 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    05

    Mylan Hospital AS

    U.S.A
    Discovery on Target
    Not Confirmed
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    U.S.A
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    Regulatory Info :

    Registration Country : Sweden

    mitomycin

    Brand Name : Mitomycin Mylan

    Dosage Form : PULVER TILL INJEKTIONS-/INFUSIONSVÄTSKA

    Dosage Strength : 40 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    06

    medac Gesellschaft für

    Country
    Discovery on Target
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    Regulatory Info :

    Registration Country : Sweden

    mitomycin

    Brand Name : Mitomycin

    Dosage Form : PULVER OCH VÄTSKA TILL INTRAVESIKAL

    Dosage Strength : 1 MG/ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    07

    medac Gesellschaft für

    Country
    Discovery on Target
    Not Confirmed
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    medac Gesellschaft für

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    Discovery on Target
    Not Confirmed
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    Regulatory Info :

    Registration Country : Sweden

    mitomycin

    Brand Name : Mitomycin

    Dosage Form : PULVER TILL INFUSIONSVÄTSKA, LÖSNING

    Dosage Strength : --

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    08

    Speciality European Pharma Ltd,

    Country
    Discovery on Target
    Not Confirmed
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    Speciality European Pharma Ltd,

    Country
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    Discovery on Target
    Not Confirmed
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    Regulatory Info :

    Registration Country : Sweden

    mitomycin

    Brand Name : Mitomycin SEP

    Dosage Form : PULVER TILL INJEKTIONS-/INFUSIONSVÄTSKA

    Dosage Strength : 20 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    09

    Speciality European Pharma Ltd,

    Country
    Discovery on Target
    Not Confirmed
    arrow

    Speciality European Pharma Ltd,

    Country
    arrow
    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Sweden

    mitomycin

    Brand Name : Mitomycin SEP

    Dosage Form : PULVER OCH VÄTSKA TILL INTRAVESIKAL

    Dosage Strength : 20 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    10

    Medac - Gesellschaft für klinische Spez...

    Country
    Discovery on Target
    Not Confirmed
    arrow

    Medac - Gesellschaft für klinische Spez...

    Country
    arrow
    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Norway

    Mitomycin

    Brand Name : Mitomycin medac

    Dosage Form : Powder and liquid to intravesikaloppløsning

    Dosage Strength : 40 mg

    Packaging : Set

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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