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    List of All Manufacturers & Suppliers of Indacaterol Maleate Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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    Indacaterol Maleate

    ACTIVE PHARMA INGREDIENTS

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    01 1CHEMO

    02 1Farmaprojects S.A.U

    03 2Novartis Pharmaceuticals Australia Pty Limited

    04 17Novartis Pharmaceuticals Corporation

    05 6Novartis South Africa (Pty) Ltd

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    01

    CHEMO

    Spain
    AAPS 2024
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    CHEMO

    Spain
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    Regulatory Info :

    Registration Country : Spain

    Indacaterol; Glycopyrronium Bromide

    Brand Name :

    Dosage Form : Capsule - Powder for Inhalation

    Dosage Strength : 85MCG; 43MCG

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    Approval Date :

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    Registration Country : Spain

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    02

    Farmaprojects S.A.U

    Spain
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    Farmaprojects S.A.U

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    Regulatory Info :

    Registration Country : Spain

    Indacaterol Maleate; Glycopyrronium Bromide

    Brand Name :

    Dosage Form : Inhalation Powder

    Dosage Strength : 85; 43

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    Registration Country : Spain

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    03

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : DISCN

    Registration Country : USA

    INDACATEROL MALEATE

    Brand Name : ARCAPTA NEOHALER

    Dosage Form : POWDER;INHALATION

    Dosage Strength : EQ 75MCG BASE

    Packaging :

    Approval Date : 2011-07-01

    Application Number : 22383

    Regulatory Info : DISCN

    Registration Country : USA

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    04

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : DISCN

    Registration Country : USA

    GLYCOPYRROLATE; INDACATEROL MALEATE

    Brand Name : UTIBRON

    Dosage Form : POWDER;INHALATION

    Dosage Strength : 15.6MCG/INH;27.5MCG/INH

    Packaging :

    Approval Date : 2015-10-29

    Application Number : 207930

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Novartis Pharmaceuticals Corporatio...

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    Flag Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Indacaterol

    Brand Name : Onbrez Breezhaler

    Dosage Form : Inh Caps

    Dosage Strength : 0.15mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    06

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Novartis Pharmaceuticals Corporatio...

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    Regulatory Info :

    Registration Country : Switzerland

    Indacaterol

    Brand Name : Onbrez Breezhaler

    Dosage Form : Inh Caps

    Dosage Strength : 0.3mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    07

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Novartis Pharmaceuticals Corporatio...

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    Regulatory Info :

    Registration Country : Switzerland

    Indacaterol

    Brand Name : Onbrez Breezhaler

    Dosage Form : Inh Caps

    Dosage Strength : 0.15mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    AAPS 2024
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    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Indacaterol

    Brand Name : Onbrez Breezhaler

    Dosage Form : Inh Caps

    Dosage Strength : 0.3mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    09

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    AAPS 2024
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    Novartis Pharmaceuticals Corporatio...

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    Registration Country : Switzerland

    Indacaterol; Mometasone-17 furoase

    Brand Name : Atectura Breezhaler

    Dosage Form : Inh Kaps

    Dosage Strength : 150mcg/160mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    10

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    AAPS 2024
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    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Indacaterol; Mometasone-17 furoase

    Brand Name : Atectura Breezhaler

    Dosage Form : Inh Kaps

    Dosage Strength : 150mcg/160mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    11

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Registration Country : Switzerland

    Indacaterol; Mometasone-17 furoase

    Brand Name : Atectura Breezhaler

    Dosage Form : Inh Kaps

    Dosage Strength : 150mcg/320mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    12

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Novartis Pharmaceuticals Corporatio...

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    Registration Country : Switzerland

    Indacaterol; Mometasone-17 furoase

    Brand Name : Atectura Breezhaler

    Dosage Form : Inh Kaps

    Dosage Strength : 150mcg/320mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    13

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Novartis Pharmaceuticals Corporatio...

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    Registration Country : Switzerland

    Indacaterol; Mometasone-17 furoase

    Brand Name : Atectura Breezhaler

    Dosage Form : Inh Kaps

    Dosage Strength : 150mcg/80mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    14

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    AAPS 2024
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    Novartis Pharmaceuticals Corporatio...

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    Indacaterol; Mometasone-17 furoase

    Brand Name : Atectura Breezhaler

    Dosage Form : Inh Kaps

    Dosage Strength : 150mcg/80mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    15

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    AAPS 2024
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    Registration Country : Switzerland

    Indacaterolum; Glycopyrronium

    Brand Name : Ultibro Breezhaler

    Dosage Form : Inh Caps

    Dosage Strength : 110mcg/50mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    16

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    AAPS 2024
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    Indacaterolum; Glycopyrronium

    Brand Name : Ultibro Breezhaler

    Dosage Form : Inh Caps

    Dosage Strength : 110mcg/50mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    17

    Novartis Pharmaceuticals Corporatio...

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    Registration Country : Switzerland

    Indacaterolum; Glycopyrronium; Mometasoni-17 furoas

    Brand Name : Enerzair Breezhaler Inha

    Dosage Form : Inh Caps

    Dosage Strength : 150/50/160Mcg

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    18

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    AAPS 2024
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    Novartis Pharmaceuticals Corporatio...

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    Registration Country : Switzerland

    Indacaterolum; Glycopyrronium; Mometasoni-17 furoas

    Brand Name : Enerzair Breezhaler Inha

    Dosage Form : Inh Caps

    Dosage Strength : 150/50/160Mcg

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    19

    Novartis Pharmaceuticals Corporatio...

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    Indacaterolum; Glycopyrronium; Mometasoni-17 furoas

    Brand Name : Enerzair Breezhaler Inha+Sens

    Dosage Form : Inh Caps

    Dosage Strength : 150/50/160Mcg

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    Registration Country : Switzerland

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    Novartis South Africa (Pty) Ltd

    Country
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    Regulatory Info : Originator

    Registration Country : South Africa

    Indacaterol

    Brand Name : Bemrist Breezhaler 150/80

    Dosage Form : CPS

    Dosage Strength : 150mcg

    Packaging : 30X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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