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    Approved Drug Products containing Nitisinone listed in the FDA Orange Book. Original Data : FDA Website

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    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Bora Pharmaceuticals- Making success more certain.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Nitisinone

    ACTIVE PHARMA INGREDIENTS

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    01 3CYCLE

    02 4ETON

    03 4MEDUNIK

    04 3NOVITIUM PHARMA

    05 5SWEDISH ORPHAN

    06 4TORRENT

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    01

    CYCLE

    United Kingdom
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    Not Confirmed
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    CYCLE

    United Kingdom
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    RLD : Yes

    TE Code :

    NITISINONE

    Brand Name : NITYR

    Dosage Form : TABLET;ORAL

    Dosage Strength : 2MG

    Approval Date : 2017-07-26

    Application Number : 209449

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    02

    CYCLE

    United Kingdom
    Discovery on Target
    Not Confirmed
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    CYCLE

    United Kingdom
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    RLD : Yes

    TE Code :

    NITISINONE

    Brand Name : NITYR

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Approval Date : 2017-07-26

    Application Number : 209449

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    CYCLE

    United Kingdom
    Discovery on Target
    Not Confirmed
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    CYCLE

    United Kingdom
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    RLD : Yes

    TE Code :

    NITISINONE

    Brand Name : NITYR

    Dosage Form : TABLET;ORAL

    Dosage Strength : 10MG

    Approval Date : 2017-07-26

    Application Number : 209449

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    NOVITIUM PHARMA

    U.S.A
    Discovery on Target
    Not Confirmed
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    U.S.A
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    RLD : No

    TE Code : AB

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2MG

    Approval Date : 2019-08-26

    Application Number : 211041

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    05

    NOVITIUM PHARMA

    U.S.A
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    Not Confirmed
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    RLD : No

    TE Code : AB

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Approval Date : 2019-08-26

    Application Number : 211041

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    06

    SWEDISH ORPHAN

    Sweden
    Discovery on Target
    Not Confirmed
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    SWEDISH ORPHAN

    Sweden
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    RLD : Yes

    TE Code : AB

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2MG

    Approval Date : 2002-01-18

    Application Number : 21232

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    07

    SWEDISH ORPHAN

    Sweden
    Discovery on Target
    Not Confirmed
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    SWEDISH ORPHAN

    Sweden
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    Discovery on Target
    Not Confirmed
    • fda
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    RLD : Yes

    TE Code : AB

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Approval Date : 2002-01-18

    Application Number : 21232

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    08

    SWEDISH ORPHAN

    Sweden
    Discovery on Target
    Not Confirmed
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    SWEDISH ORPHAN

    Sweden
    arrow
    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code : AB

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Approval Date : 2002-01-18

    Application Number : 21232

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    09

    SWEDISH ORPHAN

    Sweden
    Discovery on Target
    Not Confirmed
    arrow

    SWEDISH ORPHAN

    Sweden
    arrow
    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code : AB

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 20MG

    Approval Date : 2016-06-13

    Application Number : 21232

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    10

    SWEDISH ORPHAN

    Sweden
    Discovery on Target
    Not Confirmed
    arrow

    SWEDISH ORPHAN

    Sweden
    arrow
    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code :

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : SUSPENSION;ORAL

    Dosage Strength : 4MG/ML

    Approval Date : 2016-04-22

    Application Number : 206356

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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