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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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    Bedaquiline Fumarate

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    01

    Janssen-Cilag

    Italy
    OPRD
    Not Confirmed
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    Janssen-Cilag

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Bedaquiline

    Brand Name : Sirturo

    Dosage Form : Bedaquilina 100Mg 188 Unita' Oral Use

    Dosage Strength : 188 CPR 100 mg bottle

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    Janssen-Cilag

    Italy
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    Janssen-Cilag

    Italy
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    Regulatory Info :

    Registration Country : Norway

    Bedaquiline

    Brand Name : Sirturo

    Dosage Form : Antic-calc Tablet

    Dosage Strength : 100 mg

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    03

    Janssen-Cilag

    Italy
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    Janssen-Cilag

    Italy
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    Regulatory Info : Approved

    Registration Country : Sweden

    Bedaquiline Fumarate

    Brand Name : Sirturo

    Dosage Form : Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 05/03/2014

    Application Number : 20120908000088

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    Janssen-Cilag

    Italy
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    Regulatory Info : Approved

    Registration Country : Sweden

    Bedaquiline Fumarate

    Brand Name : Sirturo

    Dosage Form : Tablet

    Dosage Strength : 20mg

    Packaging :

    Approval Date : 26/03/2021

    Application Number : 20191127000036

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    Janssen-Cilag

    Italy
    OPRD
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    Janssen-Cilag

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    Regulatory Info : Authorized

    Registration Country : Spain

    Bedaquiline Fumarate

    Brand Name : Sirturo

    Dosage Form : Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2015-09-10

    Application Number : 113901002

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Janssen-Cilag

    Italy
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    Regulatory Info : Authorized

    Registration Country : Spain

    Bedaquiline Fumarate

    Brand Name : Sirturo

    Dosage Form : Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2014-09-18

    Application Number : 113901001

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Johnson & Johnson Innovative Medici...

    U.S.A
    Luxepack
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    Johnson & Johnson Innovative Medici...

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BEDAQUILINE FUMARATE

    Brand Name : SIRTURO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 100MG BASE

    Packaging :

    Approval Date : 2012-12-28

    Application Number : 204384

    Regulatory Info : RX

    Registration Country : USA

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    08

    Johnson & Johnson Innovative Medici...

    U.S.A
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    Johnson & Johnson Innovative Medici...

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BEDAQUILINE FUMARATE

    Brand Name : SIRTURO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 20MG BASE

    Packaging :

    Approval Date : 2020-05-27

    Application Number : 204384

    Regulatory Info : RX

    Registration Country : USA

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    09

    Johnson & Johnson Innovative Medici...

    U.S.A
    OPRD
    Not Confirmed
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    Johnson & Johnson Innovative Medici...

    U.S.A
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    OPRD
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    Regulatory Info : Originator

    Registration Country : South Africa

    Bedaquiline

    Brand Name : SIRTURO

    Dosage Form : CAP

    Dosage Strength : 100mg

    Packaging : 188X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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