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    European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    Lupin Ltd

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    IVACAFTOR

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    Vertex Pharmaceuticals

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    IVACAFTOR

    Brand Name : KALYDECO

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    Approval Date : 2012-01-31

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    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

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    Approval Date : 2015-07-02

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    Approval Date : 2016-09-28

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    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

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    Approval Date : 2015-03-17

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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

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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

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    Vertex Pharmaceuticals

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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

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    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 13.4MG/PACKET

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    Approval Date : 2023-05-03

    Application Number : 207925

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    Vertex Pharmaceuticals

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    IVACAFTOR; IVACAFTOR, TEZACAFTOR

    Brand Name : SYMDEKO (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 150MG;150MG, 100MG

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    Approval Date : 2018-02-12

    Application Number : 210491

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    IVACAFTOR; IVACAFTOR, TEZACAFTOR

    Brand Name : SYMDEKO (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 75MG;75MG, 50MG

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    Approval Date : 2019-06-21

    Application Number : 210491

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    Brand Name : ORKAMBI

    Dosage Form : GRANULE;ORAL

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

    Packaging :

    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

    Dosage Form : GRANULE;ORAL

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

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    Approval Date : 2022-09-02

    Application Number : 211358

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : TABLET;ORAL

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

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    Approval Date : 2019-10-21

    Application Number : 212273

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : TABLET;ORAL

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

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    Approval Date : 2021-06-08

    Application Number : 212273

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

    Brand Name : TRIKAFTA (COPACKAGED)

    Dosage Form : GRANULES;ORAL

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

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    Approval Date : 2023-04-26

    Application Number : 217660

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