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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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    01 9F. Hoffmann-La Roche

    02 1ORIFARM GROUP AS

    03 1Roche Diagnostics GmbH

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    01

    F. Hoffmann-La Roche

    Switzerland
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    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info : RX

    Registration Country : USA

    VEMURAFENIB

    Brand Name : ZELBORAF

    Dosage Form : TABLET;ORAL

    Dosage Strength : 240MG

    Packaging :

    Approval Date : 2011-08-17

    Application Number : 202429

    Regulatory Info : RX

    Registration Country : USA

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    02

    F. Hoffmann-La Roche

    Switzerland
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    F. Hoffmann-La Roche

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    Regulatory Info :

    Registration Country : Italy

    Plx4032

    Brand Name : Zelboraf

    Dosage Form : Vemurafenib 240Mg 56 Combined Oral Use

    Dosage Strength : 56 cpr riv 240 mg

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    Approval Date :

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    Regulatory Info :

    Registration Country : Italy

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    03

    F. Hoffmann-La Roche

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    Regulatory Info :

    Registration Country : Norway

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    Brand Name : Zelboraf

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 240 mg

    Packaging : Blister, endose

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    Regulatory Info :

    Registration Country : Norway

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    04

    F. Hoffmann-La Roche

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    Regulatory Info : Approved

    Registration Country : Sweden

    Vemurafenib

    Brand Name : Zelboraf

    Dosage Form : Film Coated Tablet

    Dosage Strength : 240mg

    Packaging :

    Approval Date : 17/02/2012

    Application Number : 20110507000015

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    F. Hoffmann-La Roche

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Vemurafenibum

    Brand Name : Zelboraf

    Dosage Form : Film Coated Tablet

    Dosage Strength : 240mg

    Packaging :

    Approval Date : 18/10/2011

    Application Number : 62139

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    06

    F. Hoffmann-La Roche

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    F. Hoffmann-La Roche

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    Regulatory Info : Prescription

    Registration Country : Canada

    VEMURAFENIB

    Brand Name : ZELBORAF

    Dosage Form : TABLET

    Dosage Strength : 240MG

    Packaging : 56

    Approval Date :

    Application Number : 2380242

    Regulatory Info : Prescription

    Registration Country : Canada

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    07

    F. Hoffmann-La Roche

    Switzerland
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    F. Hoffmann-La Roche

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    Regulatory Info : Originator

    Registration Country : South Africa

    Vemurafenib

    Brand Name : Zelboraf

    Dosage Form : FCT

    Dosage Strength : 240mg

    Packaging : 56X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    08

    F. Hoffmann-La Roche

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    Regulatory Info :

    Registration Country : Australia

    Vemurafenib

    Brand Name : Zelboraf

    Dosage Form :

    Dosage Strength :

    Packaging : 56

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    09

    F. Hoffmann-La Roche

    Switzerland
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    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info :

    Registration Country : Australia

    Vemurafenib

    Brand Name : Zelboraf

    Dosage Form :

    Dosage Strength :

    Packaging : 56

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    10

    ORIFARM GROUP AS

    Denmark
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    ORIFARM GROUP AS

    Denmark
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    Regulatory Info :

    Registration Country : Norway

    Plx4032

    Brand Name : Zelboraf

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 240 mg

    Packaging : Blister, endose

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    11

    Roche Diagnostics GmbH

    Germany
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    Roche Diagnostics GmbH

    Germany
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    Regulatory Info : Authorized

    Registration Country : Spain

    Vemurafenib

    Brand Name : Zelboraf

    Dosage Form : Film Coated Tablet

    Dosage Strength : 240MG

    Packaging :

    Approval Date : 2012-03-27

    Application Number : 12751001

    Regulatory Info : Authorized

    Registration Country : Spain

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