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    List of All Manufacturers & Suppliers of Nitisinone Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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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

    DEVELOPMENTS

    PRICE INFORMATION

    FINISHED DOSAGE FORMULATIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

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    01 3CYCLE PHARMACEUTICALS LTD.

    02 3Cycle Pharmaceuticals

    03 7Dipharma

    04 4Eton Pharmaceuticals

    05 4MEDUNIK CANADA

    06 3Mendeli Kabs

    07 2Nobel Ilac Sanayii Ve Ticaret A.S.

    08 3Novitium Pharma LLC

    09 27Swedish Orphan Biovitrum AB

    10 4Torrent Pharmaceuticals Limited

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    01

    Cycle Pharmaceuticals

    United Kingdom
    Discovery on Target
    Not Confirmed
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    Cycle Pharmaceuticals

    United Kingdom
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    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITYR

    Dosage Form : TABLET;ORAL

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2017-07-26

    Application Number : 209449

    Regulatory Info : RX

    Registration Country : USA

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    02

    Cycle Pharmaceuticals

    United Kingdom
    Discovery on Target
    Not Confirmed
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    Cycle Pharmaceuticals

    United Kingdom
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    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITYR

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2017-07-26

    Application Number : 209449

    Regulatory Info : RX

    Registration Country : USA

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    03

    Cycle Pharmaceuticals

    United Kingdom
    Discovery on Target
    Not Confirmed
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    Cycle Pharmaceuticals

    United Kingdom
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    Discovery on Target
    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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    Flag United Kingdom
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITYR

    Dosage Form : TABLET;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2017-07-26

    Application Number : 209449

    Regulatory Info : RX

    Registration Country : USA

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    04

    Eton Pharmaceuticals

    U.S.A
    Discovery on Target
    Not Confirmed
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    Eton Pharmaceuticals

    U.S.A
    arrow
    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2023-05-25

    Application Number : 216201

    Regulatory Info : RX

    Registration Country : USA

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    05

    MEDUNIK CANADA

    Canada
    Discovery on Target
    Not Confirmed
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    MEDUNIK CANADA

    Canada
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    Discovery on Target
    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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    Flag Canada
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2022-05-26

    Application Number : 212390

    Regulatory Info : RX

    Registration Country : USA

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    06

    MEDUNIK CANADA

    Canada
    Discovery on Target
    Not Confirmed
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    MEDUNIK CANADA

    Canada
    arrow
    Discovery on Target
    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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    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2022-05-26

    Application Number : 212390

    Regulatory Info : RX

    Registration Country : USA

    blank

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    07

    MEDUNIK CANADA

    Canada
    Discovery on Target
    Not Confirmed
    arrow

    MEDUNIK CANADA

    Canada
    arrow
    Discovery on Target
    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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    Flag Canada
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2022-05-26

    Application Number : 212390

    Regulatory Info : RX

    Registration Country : USA

    blank

    Portfolio PDF

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    08

    MEDUNIK CANADA

    Canada
    Discovery on Target
    Not Confirmed
    arrow

    MEDUNIK CANADA

    Canada
    arrow
    Discovery on Target
    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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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 2023-04-27

    Application Number : 212390

    Regulatory Info : RX

    Registration Country : USA

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    09

    Novitium Pharma LLC

    U.S.A
    Discovery on Target
    Not Confirmed
    arrow

    Novitium Pharma LLC

    U.S.A
    arrow
    Discovery on Target
    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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    Flag U.S.A
    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2019-08-26

    Application Number : 211041

    Regulatory Info : RX

    Registration Country : USA

    blank

    Portfolio PDF

    Product Web Link

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    Digital Content

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    10

    Novitium Pharma LLC

    U.S.A
    Discovery on Target
    Not Confirmed
    arrow

    Novitium Pharma LLC

    U.S.A
    arrow
    Discovery on Target
    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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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2019-08-26

    Application Number : 211041

    Regulatory Info : RX

    Registration Country : USA

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    11

    Novitium Pharma LLC

    U.S.A
    Discovery on Target
    Not Confirmed
    arrow

    Novitium Pharma LLC

    U.S.A
    arrow
    Discovery on Target
    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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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2019-08-26

    Application Number : 211041

    Regulatory Info : RX

    Registration Country : USA

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    12

    Swedish Orphan Biovitrum AB

    Sweden
    Discovery on Target
    Not Confirmed
    arrow

    Swedish Orphan Biovitrum AB

    Sweden
    arrow
    Discovery on Target
    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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    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2002-01-18

    Application Number : 21232

    Regulatory Info : RX

    Registration Country : USA

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    Portfolio PDF

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    13

    Swedish Orphan Biovitrum AB

    Sweden
    Discovery on Target
    Not Confirmed
    arrow

    Swedish Orphan Biovitrum AB

    Sweden
    arrow
    Discovery on Target
    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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    Flag Sweden
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2002-01-18

    Application Number : 21232

    Regulatory Info : RX

    Registration Country : USA

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    Portfolio PDF

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    14

    Swedish Orphan Biovitrum AB

    Sweden
    Discovery on Target
    Not Confirmed
    arrow

    Swedish Orphan Biovitrum AB

    Sweden
    arrow
    Discovery on Target
    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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    Flag Sweden
    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2002-01-18

    Application Number : 21232

    Regulatory Info : RX

    Registration Country : USA

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    Portfolio PDF

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    Digital Content

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    15

    Swedish Orphan Biovitrum AB

    Sweden
    Discovery on Target
    Not Confirmed
    arrow

    Swedish Orphan Biovitrum AB

    Sweden
    arrow
    Discovery on Target
    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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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 2016-06-13

    Application Number : 21232

    Regulatory Info : RX

    Registration Country : USA

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    16

    Swedish Orphan Biovitrum AB

    Sweden
    Discovery on Target
    Not Confirmed
    arrow

    Swedish Orphan Biovitrum AB

    Sweden
    arrow
    Discovery on Target
    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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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : ORFADIN

    Dosage Form : SUSPENSION;ORAL

    Dosage Strength : 4MG/ML

    Packaging :

    Approval Date : 2016-04-22

    Application Number : 206356

    Regulatory Info : RX

    Registration Country : USA

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    17

    Torrent Pharmaceuticals Limited

    India
    Discovery on Target
    Not Confirmed
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    Torrent Pharmaceuticals Limited

    India
    arrow
    Discovery on Target
    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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    Regulatory Info : DISCN

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2023-01-09

    Application Number : 215908

    Regulatory Info : DISCN

    Registration Country : USA

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    18

    Torrent Pharmaceuticals Limited

    India
    Discovery on Target
    Not Confirmed
    arrow

    Torrent Pharmaceuticals Limited

    India
    arrow
    Discovery on Target
    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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    Virtual Booth Virtual Booth
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    Regulatory Info : DISCN

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2023-01-09

    Application Number : 215908

    Regulatory Info : DISCN

    Registration Country : USA

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    19

    Torrent Pharmaceuticals Limited

    India
    Discovery on Target
    Not Confirmed
    arrow

    Torrent Pharmaceuticals Limited

    India
    arrow
    Discovery on Target
    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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    Regulatory Info : DISCN

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2023-01-09

    Application Number : 215908

    Regulatory Info : DISCN

    Registration Country : USA

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    20

    Torrent Pharmaceuticals Limited

    India
    Discovery on Target
    Not Confirmed
    arrow

    Torrent Pharmaceuticals Limited

    India
    arrow
    Discovery on Target
    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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    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info : DISCN

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 2023-01-09

    Application Number : 215908

    Regulatory Info : DISCN

    Registration Country : USA

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