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    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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    xyz-pharma-m-2024-10-07

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    With Fermion, start the journey of your innovative API.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    Kalydeco

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    01 1LUPIN LTD

    02 1VERTEX PHARMS

    03 16VERTEX PHARMS INC

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    01

    VERTEX PHARMS

    U.S.A
    Antibody Engineering
    Not Confirmed
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    VERTEX PHARMS

    U.S.A
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    Antibody Engineering
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    RLD : Yes

    TE Code :

    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : TABLET;ORAL

    Dosage Strength : 150MG

    Approval Date : 2012-01-31

    Application Number : 203188

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    02

    VERTEX PHARMS INC

    U.S.A
    Antibody Engineering
    Not Confirmed
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    VERTEX PHARMS INC

    U.S.A
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code :

    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : TABLET;ORAL

    Dosage Strength : 125MG;200MG

    Approval Date : 2015-07-02

    Application Number : 206038

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    03

    VERTEX PHARMS INC

    U.S.A
    Antibody Engineering
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    VERTEX PHARMS INC

    U.S.A
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    Antibody Engineering
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    RLD : Yes

    TE Code :

    IVACAFTOR; LUMACAFTOR

    Brand Name : ORKAMBI

    Dosage Form : TABLET;ORAL

    Dosage Strength : 125MG;100MG

    Approval Date : 2016-09-28

    Application Number : 206038

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    VERTEX PHARMS INC

    U.S.A
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    Antibody Engineering
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    RLD : Yes

    TE Code :

    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 50MG/PACKET

    Approval Date : 2015-03-17

    Application Number : 207925

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    05

    VERTEX PHARMS INC

    U.S.A
    Antibody Engineering
    Not Confirmed
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    VERTEX PHARMS INC

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    Antibody Engineering
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    RLD : Yes

    TE Code :

    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 75MG/PACKET

    Approval Date : 2015-03-17

    Application Number : 207925

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    06

    VERTEX PHARMS INC

    U.S.A
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    Not Confirmed
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    VERTEX PHARMS INC

    U.S.A
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    Antibody Engineering
    Not Confirmed
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    RLD : Yes

    TE Code :

    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 25MG/PACKET

    Approval Date : 2019-04-29

    Application Number : 207925

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    07

    VERTEX PHARMS INC

    U.S.A
    Antibody Engineering
    Not Confirmed
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    VERTEX PHARMS INC

    U.S.A
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    Antibody Engineering
    Not Confirmed
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    • EDQM
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    RLD : Yes

    TE Code :

    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 5.8MG/PACKET

    Approval Date : 2023-05-03

    Application Number : 207925

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    08

    VERTEX PHARMS INC

    U.S.A
    Antibody Engineering
    Not Confirmed
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    VERTEX PHARMS INC

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    Antibody Engineering
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    RLD : Yes

    TE Code :

    IVACAFTOR

    Brand Name : KALYDECO

    Dosage Form : GRANULE;ORAL

    Dosage Strength : 13.4MG/PACKET

    Approval Date : 2023-05-03

    Application Number : 207925

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    09

    VERTEX PHARMS INC

    U.S.A
    Antibody Engineering
    Not Confirmed
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    VERTEX PHARMS INC

    U.S.A
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    RLD : Yes

    TE Code :

    IVACAFTOR; IVACAFTOR, TEZACAFTOR

    Brand Name : SYMDEKO (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 150MG;150MG, 100MG

    Approval Date : 2018-02-12

    Application Number : 210491

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    10

    VERTEX PHARMS INC

    U.S.A
    Antibody Engineering
    Not Confirmed
    arrow

    VERTEX PHARMS INC

    U.S.A
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    RLD : Yes

    TE Code :

    IVACAFTOR; IVACAFTOR, TEZACAFTOR

    Brand Name : SYMDEKO (COPACKAGED)

    Dosage Form : TABLET;ORAL

    Dosage Strength : 75MG;75MG, 50MG

    Approval Date : 2019-06-21

    Application Number : 210491

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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