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    01 1ALFRED E TIEFENBACHER GmbH & Co KG

    02 1ACTELION REGISTRATION LTD

    03 1Acte Lion Registration Ltd

    04 1Actelion Pharmaceuticals Ltd

    05 1Clonmel Healthcare Limited

    06 1Devatis Gmbh

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    ALFRED E TIEFENBACHER GmbH & Co KG

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    Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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    Regulatory Info : EU Dossier Readiness-Q4 2023

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    Dosage Form : Film Coated Tablet

    Dosage Strength : 10MG

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    Regulatory Info : EU Dossier Readiness-Q4 2023

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    Devatis Gmbh

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    Regulatory Info : Approved

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    Brand Name : Macitentan Devatis

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    Approval Date : 03/07/2025

    Application Number : 20240314000073

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    Glenmark Arzneimittel Gmbh

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    Regulatory Info : Approved

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    Brand Name : Macitentan Glenmark

    Dosage Form : Film Coated Tablet

    Dosage Strength : 10mg

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    Approval Date : 24/03/2025

    Application Number : 20231221000157

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    Janssen-Cilag International Nv

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    Regulatory Info : Approved

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    Brand Name : Opsumit

    Dosage Form : Film Coated Tablet

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    Approval Date : 20/12/2013

    Application Number : 20121211000079

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    Janssen-Cilag International Nv

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    Regulatory Info : Approved

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    Brand Name : Opsumit

    Dosage Form : Dispersible Tablet

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    Approval Date : 04/10/2024

    Application Number : 20231009000171

    Regulatory Info : Approved

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    ACTELION REGISTRATION LTD

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    ACTELION REGISTRATION LTD

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    Brand Name : Opsumit

    Dosage Form : Macitentan 10Mg 30 Joined' Oral Use

    Dosage Strength : 30 cpr riv 10 mg

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    Acte Lion Registration Ltd

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    Brand Name : Opsumit

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 10 mg

    Packaging : Blister

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    Actelion Pharmaceuticals Ltd

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    Regulatory Info : Allowed

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    Brand Name : Opsumit

    Dosage Form : Film Coated Tablet

    Dosage Strength : 10mg

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    Approval Date : 06/02/2014

    Application Number : 61863

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Teva Gmbh

    Israel
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    Regulatory Info : Approved

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    Brand Name : Macitentan Teva

    Dosage Form : Film Coated Tablet

    Dosage Strength : 10mg

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    Approval Date : 09/05/2025

    Application Number : 20231228000105

    Regulatory Info : Approved

    Registration Country : Sweden

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    Newbury Pharmaceuticals Ab

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    Regulatory Info : Approved

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    Brand Name : Macitentan Newbury

    Dosage Form : Film Coated Tablet

    Dosage Strength : 10mg

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    Approval Date : 27/03/2025

    Application Number : 20231221000010

    Regulatory Info : Approved

    Registration Country : Sweden

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