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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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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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    Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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    Vertex Pharmaceuticals

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : TABLET;ORAL

    Dosage Strength : 125MG;200MG

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    Approval Date : 2015-07-02

    Application Number : 206038

    Regulatory Info : RX

    Registration Country : USA

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    02

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : TABLET;ORAL

    Dosage Strength : 125MG;100MG

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    Approval Date : 2016-09-28

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    03

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 125MG/PACKET;100MG/PACKET

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    Approval Date : 2018-08-07

    Application Number : 211358

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 188MG/PACKET;150MG/PACKET

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    Approval Date : 2018-08-07

    Application Number : 211358

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

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    Dosage Strength : 94MG/PACKET;75MG/PACKET

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    Approval Date : 2022-09-02

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    07

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    Regulatory Info : Marketed

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    Lumacaftor; Ivacaftor

    Brand Name : Orkambi

    Dosage Form : Granules

    Dosage Strength : 150mg; 188mg

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    Registration Country : Norway

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    08

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    Regulatory Info : Marketed

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    Lumacaftor; Ivacaftor

    Brand Name : Orkambi

    Dosage Form : Granules

    Dosage Strength : 75mg; 94mg

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    Regulatory Info : Marketed

    Registration Country : Norway

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    09

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    Regulatory Info : Marketed

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    Lumacaftor; Ivacaftor

    Brand Name : Orkambi

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg; 125mg

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    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    10

    Vertex Pharmaceuticals

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    Regulatory Info : Marketed

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    Lumacaftor; Ivacaftor

    Brand Name : Orkambi

    Dosage Form : Film Coated Tablet

    Dosage Strength : 200mg; 125mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    11

    Vertex Pharmaceuticals

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Ivacaftor; Lumacaftor

    Brand Name : Orkambi

    Dosage Form : Granule In Sachet

    Dosage Strength : 125mg; 100mg

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    12

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Ivacaftor; Lumacaftor

    Brand Name : Orkambi

    Dosage Form : Film-Coated Tablet

    Dosage Strength : 125mg; 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    13

    Vertex Pharmaceuticals

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    SCOPE Summit
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Ivacaftor; Lumacaftor

    Brand Name : Orkambi

    Dosage Form : Film-Coated Tablet

    Dosage Strength : 125mg; 200mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    14

    Vertex Pharmaceuticals

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Ivacaftor; Lumacaftor

    Brand Name : Orkambi

    Dosage Form : Granule In Sachet

    Dosage Strength : 188mg; 150mg

    Packaging :

    Approval Date :

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    15

    Vertex Pharmaceuticals

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Ivacaftor; Lumacaftor

    Brand Name : Orkambi

    Dosage Form : Granule In Sachet

    Dosage Strength : 94mg; 75mg

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    16

    Vertex Pharmaceuticals

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    Regulatory Info : Authorized

    Registration Country : Spain

    Ivacaftor; Lumacaftor

    Brand Name : Orcambi

    Dosage Form : Granule In Sachet

    Dosage Strength : 150MG; 188 MG

    Packaging :

    Approval Date : 28-02-2019

    Application Number : 1151059007

    Regulatory Info : Authorized

    Registration Country : Spain

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    17

    Vertex Pharmaceuticals

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    Regulatory Info : Authorized

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    Ivacaftor; Lumacaftor

    Brand Name : Orcambi

    Dosage Form : Granule In Sachet

    Dosage Strength : 75MG; 94 MG

    Packaging :

    Approval Date : 26-07-2023

    Application Number : 1151059008

    Regulatory Info : Authorized

    Registration Country : Spain

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    18

    Vertex Pharmaceuticals

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    Regulatory Info : Authorized

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    Ivacaftor; Lumacaftor

    Brand Name : Orcambi

    Dosage Form : Film Coated Tablet

    Dosage Strength : 200MG; 125 MG

    Packaging :

    Approval Date : 07-07-2016

    Application Number : 1151059001

    Regulatory Info : Authorized

    Registration Country : Spain

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    19

    Vertex Pharmaceuticals

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    Ivacaftor; Lumacaftor

    Brand Name : Orcambi

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100MG; 125 MG

    Packaging :

    Approval Date : 05-04-2018

    Application Number : 1151059005

    Regulatory Info : Authorized

    Registration Country : Spain

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    Vertex Pharmaceuticals

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    Regulatory Info : Authorized

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    Ivacaftor; Lumacaftor

    Brand Name : Orcambi

    Dosage Form : Granule In Sachet

    Dosage Strength : 100MG; 125 MG

    Packaging :

    Approval Date : 28-02-2019

    Application Number : 1151059006

    Regulatory Info : Authorized

    Registration Country : Spain

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