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    01 1Medichem S.A

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    Medichem S.A

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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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    Ivacaftor

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    Dosage Form : Film Coated Tablet

    Dosage Strength : 150MG

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    Registration Country : Spain

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    02

    Lupin Ltd

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    Lupin Ltd

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    IVACAFTOR

    Brand Name : IVACAFTOR

    Dosage Form : TABLET; ORAL

    Dosage Strength : 150MG

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    Application Number : 216074

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    Registration Country : USA

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    03

    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

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    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : TABLET;ORAL

    Dosage Strength : 150MG

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    Approval Date : 2012-01-31

    Application Number : 203188

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

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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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    05

    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

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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

    Application Number : 206038

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

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    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 50MG/PACKET

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    Approval Date : 2015-03-17

    Application Number : 207925

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

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    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 75MG/PACKET

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    Approval Date : 2015-03-17

    Application Number : 207925

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 25MG/PACKET

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    Approval Date : 2019-04-29

    Application Number : 207925

    Regulatory Info : RX

    Registration Country : USA

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    09

    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

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    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 5.8MG/PACKET

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    Approval Date : 2023-05-03

    Application Number : 207925

    Regulatory Info : RX

    Registration Country : USA

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    10

    Vertex Pharmaceuticals

    U.S.A
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    Vertex Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 13.4MG/PACKET

    Packaging :

    Approval Date : 2023-05-03

    Application Number : 207925

    Regulatory Info : RX

    Registration Country : USA

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    11

    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    IVACAFTOR; IVACAFTOR, TEZACAFTOR

    Brand Name : SYMDEKO (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 150MG;150MG, 100MG

    Packaging :

    Approval Date : 2018-02-12

    Application Number : 210491

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    IVACAFTOR; IVACAFTOR, TEZACAFTOR

    Brand Name : SYMDEKO (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 75MG;75MG, 50MG

    Packaging :

    Approval Date : 2019-06-21

    Application Number : 210491

    Regulatory Info : RX

    Registration Country : USA

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    13

    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Compamed
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    Regulatory Info : RX

    Registration Country : USA

    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

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

    Packaging :

    Approval Date : 2018-08-07

    Application Number : 211358

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

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

    Packaging :

    Approval Date : 2018-08-07

    Application Number : 211358

    Regulatory Info : RX

    Registration Country : USA

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    15

    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

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

    Packaging :

    Approval Date : 2022-09-02

    Application Number : 211358

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG,75MG,50MG; 150MG

    Packaging :

    Approval Date : 2019-10-21

    Application Number : 212273

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG,37.5MG,25MG; 75MG

    Packaging :

    Approval Date : 2021-06-08

    Application Number : 212273

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : GRANULES;ORAL

    Dosage Strength : 80MG, 60MG, 40MG;59.5MG

    Packaging :

    Approval Date : 2023-04-26

    Application Number : 217660

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : GRANULES;ORAL

    Dosage Strength : 100MG, 75MG, 50MG;75MG

    Packaging :

    Approval Date : 2023-04-26

    Application Number : 217660

    Regulatory Info : RX

    Registration Country : USA

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    Vertex Pharmaceuticals

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    Vertex Pharmaceuticals

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    Regulatory Info :

    Registration Country : Sweden

    ivakaftor

    Brand Name : Kalydeco

    Dosage Form : FILM COATED PILL

    Dosage Strength : 150 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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