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    All Manufacturers, Suppliers, Distributors and Exporters of Kalydeco with approved FDA Orange Book of Finished Dosage Form listed on PharmaCompass.com

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    LUPIN LTD

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    IVACAFTOR

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    TABLET; ORAL
    150MG
    216074
    IVACAFTOR
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    VERTEX PHARMS

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    IVACAFTOR

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    TABLET;ORAL
    150MG
    2012-01-31
    203188
    KALYDECO
    RX
    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR; LUMACAFTOR

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    TABLET;ORAL
    125MG;200MG
    2015-07-02
    206038
    ORKAMBI
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    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR; LUMACAFTOR

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    TABLET;ORAL
    125MG;100MG
    2016-09-28
    206038
    ORKAMBI
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    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR

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    GRANULE;ORAL
    50MG/PACKET
    2015-03-17
    207925
    KALYDECO
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    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR

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    GRANULE;ORAL
    75MG/PACKET
    2015-03-17
    207925
    KALYDECO
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    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR

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    GRANULE;ORAL
    25MG/PACKET
    2019-04-29
    207925
    KALYDECO
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    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR

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    GRANULE;ORAL
    5.8MG/PACKET
    2023-05-03
    207925
    KALYDECO
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    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR

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    GRANULE;ORAL
    13.4MG/PACKET
    2023-05-03
    207925
    KALYDECO
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    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR; IVACAFTOR, TEZACAFTOR

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    TABLET;ORAL
    150MG;150MG, 100MG
    2018-02-12
    210491
    SYMDEKO (COPACKAGED)
    RX
    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR; IVACAFTOR, TEZACAFTOR

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    TABLET;ORAL
    75MG;75MG, 50MG
    2019-06-21
    210491
    SYMDEKO (COPACKAGED)
    RX
    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR; LUMACAFTOR

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    GRANULE;ORAL
    125MG/PACKET;100MG/PACKET
    2018-08-07
    211358
    ORKAMBI
    RX
    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR; LUMACAFTOR

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    GRANULE;ORAL
    188MG/PACKET;150MG/PACKET
    2018-08-07
    211358
    ORKAMBI
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    Yes
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    VERTEX PHARMS INC

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    IVACAFTOR; LUMACAFTOR

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    GRANULE;ORAL
    94MG/PACKET;75MG/PACKET
    2022-09-02
    211358
    ORKAMBI
    RX
    Yes
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    VERTEX PHARMS INC

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

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    TABLET;ORAL
    100MG,75MG,50MG; 150MG
    2019-10-21
    212273
    TRIKAFTA (COPACKAGED)
    RX
    Yes
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    VERTEX PHARMS INC

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

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    TABLET;ORAL
    50MG,37.5MG,25MG; 75MG
    2021-06-08
    212273
    TRIKAFTA (COPACKAGED)
    RX
    Yes
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    VERTEX PHARMS INC

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

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    GRANULES;ORAL
    80MG, 60MG, 40MG;59.5MG
    2023-04-26
    217660
    TRIKAFTA (COPACKAGED)
    RX
    Yes
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    VERTEX PHARMS INC

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    ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

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    GRANULES;ORAL
    100MG, 75MG, 50MG;75MG
    2023-04-26
    217660
    TRIKAFTA (COPACKAGED)
    RX
    Yes
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