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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    Niraparib

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    01 2GlaxoSmithKline (Ireland) Limited

    02 2Glaxosmithkline (Ireland) Limited

    03 2Glaxosmithkline Ag

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    01

    GlaxoSmithKline (Ireland) Limited

    United Kingdom
    The MedTech Conference
    Not Confirmed
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    GlaxoSmithKline (Ireland) Limited

    United Kingdom
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    The MedTech Conference
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    Regulatory Info :

    Registration Country : Norway

    Niraparibtosilatmonohydrat

    Brand Name : Zejula

    Dosage Form : Tablet, film-coated

    Dosage Strength : 100 mg

    Packaging : Blisterpakning 56item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    02

    GlaxoSmithKline (Ireland) Limited

    United Kingdom
    The MedTech Conference
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    GlaxoSmithKline (Ireland) Limited

    United Kingdom
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    The MedTech Conference
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    Regulatory Info :

    Registration Country : Norway

    Niraparibtosilatmonohydrat

    Brand Name : Zejula

    Dosage Form : Tablet, film-coated

    Dosage Strength : 100 mg

    Packaging : Blisterpakning 84item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    03

    Glaxosmithkline Ag

    United Kingdom
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    Glaxosmithkline Ag

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Niraparibum

    Brand Name : Zejula capsules

    Dosage Form : Capsule

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 03/10/2018

    Application Number : 66763

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    04

    Glaxosmithkline Ag

    United Kingdom
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    Glaxosmithkline Ag

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Niraparibum

    Brand Name : Zejula

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 20/01/2023

    Application Number : 68652

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    05

    Glaxosmithkline (Ireland) Limited

    United Kingdom
    The MedTech Conference
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    Glaxosmithkline (Ireland) Limited

    United Kingdom
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    The MedTech Conference
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    Regulatory Info : Authorized

    Registration Country : Spain

    Niraparib Tosylate Monohydrate

    Brand Name : Zejula

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2024-04-12

    Application Number : 1171235006

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Glaxosmithkline (Ireland) Limited

    United Kingdom
    The MedTech Conference
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    Glaxosmithkline (Ireland) Limited

    United Kingdom
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    The MedTech Conference
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    Regulatory Info : Authorized

    Registration Country : Spain

    Niraparib Tosylate Monohydrate

    Brand Name : Zejula

    Dosage Form : Hard Capsule

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2018-03-08

    Application Number : 1171235001

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Janssen-Cilag Ag

    Italy
    The MedTech Conference
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    Janssen-Cilag Ag

    Italy
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Niraparib; Abiraterone Acetate

    Brand Name : Akeega mg

    Dosage Form : Film Coated Tablet

    Dosage Strength : 50mg;500mg

    Packaging :

    Approval Date : 18/04/2024

    Application Number : 68977

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    08

    Janssen-Cilag Ag

    Italy
    The MedTech Conference
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    Janssen-Cilag Ag

    Italy
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    The MedTech Conference
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Niraparib; Abiraterone Acetate

    Brand Name : Akeega mg

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg;500mg

    Packaging :

    Approval Date : 18/04/2024

    Application Number : 68977

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    09

    Janssen-Cilag International N.V.

    Italy
    The MedTech Conference
    Not Confirmed
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    Janssen-Cilag International N.V.

    Italy
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : Authorized

    Registration Country : Spain

    Abiraterone Acetate; Niraparib Tosylate Monohydrate

    Brand Name : Akeega

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100MG; 500 MG

    Packaging :

    Approval Date : 2023-04-27

    Application Number : 1231722002

    Regulatory Info : Authorized

    Registration Country : Spain

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    10

    Janssen-Cilag International N.V.

    Italy
    The MedTech Conference
    Not Confirmed
    arrow

    Janssen-Cilag International N.V.

    Italy
    arrow
    The MedTech Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Regulatory Info : Authorized

    Registration Country : Spain

    Abiraterone Acetate; Niraparib Tosylate Monohydrate

    Brand Name : Akeega

    Dosage Form : Film Coated Tablet

    Dosage Strength : 50MG; 500 MG

    Packaging :

    Approval Date : 2023-04-27

    Application Number : 1231722001

    Regulatory Info : Authorized

    Registration Country : Spain

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