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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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    Trastuzumab Emtansine

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    01

    F. Hoffmann-La Roche

    Switzerland
    PEGS Boston Summit
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    Regulatory Info : Allowed

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    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 100mg

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    Approval Date : 02/05/2013

    Application Number : 62892

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    02

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    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 160mg

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    Approval Date : 02/05/2013

    Application Number : 62892

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    03

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    Trastuzumabemtansin

    Brand Name : Kadcyla

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    Trastuzumabemtansin

    Brand Name : Kadcyla

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    05

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Trastuzumab emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

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    06

    F. Hoffmann-La Roche

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Trastuzumab emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 160mg

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    Registration Country : Estonia

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    07

    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info : Prescription

    Registration Country : Denmark

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 100mg

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    Approval Date : 15-11-2013

    Application Number : 28105143712

    Regulatory Info : Prescription

    Registration Country : Denmark

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    08

    F. Hoffmann-La Roche

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 160mg

    Packaging :

    Approval Date : 15-11-2013

    Application Number : 28105143812

    Regulatory Info : Prescription

    Registration Country : Denmark

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    09

    F. Hoffmann-La Roche

    Switzerland
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    Switzerland
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    Regulatory Info : Approved

    Registration Country : Sweden

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 15-11-2013

    Application Number : 2.01E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    10

    F. Hoffmann-La Roche

    Switzerland
    PEGS Boston Summit
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    Switzerland
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    PEGS Boston Summit
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 160mg

    Packaging :

    Approval Date : 15-11-2013

    Application Number : 2.01E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    11

    F. Hoffmann-La Roche

    Switzerland
    PEGS Boston Summit
    Not Confirmed
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    Switzerland
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    Regulatory Info : PRESCRIPTION

    Registration Country : Canada

    TRASTUZUMAB EMTANSINE

    Brand Name : KADCYLA

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 100MG/VIAL

    Packaging : 15ML/20ML

    Approval Date :

    Application Number : 2412365

    Regulatory Info : PRESCRIPTION

    Registration Country : Canada

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    12

    F. Hoffmann-La Roche

    Switzerland
    PEGS Boston Summit
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    Switzerland
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    Regulatory Info : PRESCRIPTION

    Registration Country : Canada

    TRASTUZUMAB EMTANSINE

    Brand Name : KADCYLA

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 160MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 2473224

    Regulatory Info : PRESCRIPTION

    Registration Country : Canada

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    13

    F. Hoffmann-La Roche

    Switzerland
    PEGS Boston Summit
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    Switzerland
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    Regulatory Info : Originator

    Registration Country : South Africa

    Trastuzumab Emtansine

    Brand Name : Kadcyla 100

    Dosage Form : INF

    Dosage Strength : 100mg

    Packaging : 5X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    14

    F. Hoffmann-La Roche

    Switzerland
    PEGS Boston Summit
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    Switzerland
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    Regulatory Info : Originator

    Registration Country : South Africa

    Trastuzumab Emtansine

    Brand Name : Kadcyla 160

    Dosage Form : INF

    Dosage Strength : 160mg

    Packaging : 8X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    15

    Roche Diagnostics GmbH

    Germany
    PEGS Boston Summit
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    Roche Diagnostics GmbH

    Germany
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    Regulatory Info : Authorized

    Registration Country : Spain

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 26-12-2013

    Application Number : 113885001

    Regulatory Info : Authorized

    Registration Country : Spain

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    16

    Roche Diagnostics GmbH

    Germany
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    Regulatory Info : Authorized

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    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 160MG

    Packaging :

    Approval Date : 03-11-2020

    Application Number : 113885002IP

    Regulatory Info : Authorized

    Registration Country : Spain

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    17

    Roche Diagnostics GmbH

    Germany
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    Regulatory Info : Authorized

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    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 22-05-2024

    Application Number : 113885001IP1

    Regulatory Info : Authorized

    Registration Country : Spain

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    18

    Roche Diagnostics GmbH

    Germany
    PEGS Boston Summit
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    Roche Diagnostics GmbH

    Germany
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    Regulatory Info : Authorized

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    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 160MG

    Packaging :

    Approval Date : 22-05-2024

    Application Number : 113885002IP1

    Regulatory Info : Authorized

    Registration Country : Spain

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    19

    Roche Diagnostics GmbH

    Germany
    PEGS Boston Summit
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    Germany
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    PEGS Boston Summit
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    Regulatory Info : Authorized

    Registration Country : Spain

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 160MG

    Packaging :

    Approval Date : 26-12-2013

    Application Number : 113885002

    Regulatory Info : Authorized

    Registration Country : Spain

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    20

    Roche Diagnostics GmbH

    Germany
    PEGS Boston Summit
    Not Confirmed
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    Roche Diagnostics GmbH

    Germany
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    PEGS Boston Summit
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 03-11-2020

    Application Number : 113885001IP

    Regulatory Info : Authorized

    Registration Country : Spain

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