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

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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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    GATTEX KIT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

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    01 1NPS Pharma Holdings Ltd,

    02 1Olon S.p.A

    03 1SHIRE PLC

    04 2Takeda Pharmaceutical

    05 6Takeda Pharmaceuticals Australia Pty. Ltd.

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    01

    Olon S.p.A

    Italy
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    Olon S.p.A

    Italy
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    Regulatory Info : Available Dossier- US

    Registration Country : Italy

    Teduglutide Recombinant

    Brand Name :

    Dosage Form : Lyophilizate

    Dosage Strength : 5MG

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info : Available Dossier- US

    Registration Country : Italy

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    02

    SHIRE PLC

    Ireland
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    SHIRE PLC

    Ireland
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    Regulatory Info :

    Registration Country : Norway

    Teduglutide Recombinant

    Brand Name : Revestive

    Dosage Form : Powder and liquid to the injection fluid, resolution

    Dosage Strength : 5 mg

    Packaging : Set

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    03

    Takeda Pharmaceutical

    Japan
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    Takeda Pharmaceutical

    Japan
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    Regulatory Info : RX

    Registration Country : USA

    TEDUGLUTIDE

    Brand Name : GATTEX KIT

    Dosage Form : POWDER;SUBCUTANEOUS

    Dosage Strength : 5MG/VIAL

    Packaging :

    Approval Date : 2012-12-21

    Application Number : 203441

    Regulatory Info : RX

    Registration Country : USA

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    04

    Takeda Pharmaceutical

    Japan
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    Takeda Pharmaceutical

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    Regulatory Info : Prescription

    Registration Country : Canada

    TEDUGLUTIDE

    Brand Name : REVESTIVE

    Dosage Form : KIT

    Dosage Strength : 5MG/VIAL

    Packaging : 28X5MG VIALS & 28X0.5ML PFS

    Approval Date :

    Application Number : 2445727

    Regulatory Info : Prescription

    Registration Country : Canada

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    05

    NPS Pharma Holdings Ltd,

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    NPS Pharma Holdings Ltd,

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    Regulatory Info :

    Registration Country : Sweden

    teduglutid

    Brand Name : Revestive

    Dosage Form : PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA

    Dosage Strength : 5 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    06

    Takeda Pharmaceuticals Australia Pt...

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    Regulatory Info :

    Registration Country : Australia

    teduglutide

    Brand Name : Revestive

    Dosage Form :

    Dosage Strength :

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    07

    Takeda Pharmaceuticals Australia Pt...

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    Takeda Pharmaceuticals Australia Pt...

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    Regulatory Info :

    Registration Country : Australia

    teduglutide

    Brand Name : Revestive

    Dosage Form :

    Dosage Strength :

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    08

    Takeda Pharmaceuticals Australia Pt...

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    Takeda Pharmaceuticals Australia Pt...

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    Regulatory Info :

    Registration Country : Australia

    teduglutide

    Brand Name : Revestive

    Dosage Form :

    Dosage Strength :

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    09

    Takeda Pharmaceuticals Australia Pt...

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    Takeda Pharmaceuticals Australia Pt...

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    Regulatory Info :

    Registration Country : Australia

    teduglutide

    Brand Name : Revestive

    Dosage Form :

    Dosage Strength :

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    10

    Takeda Pharmaceuticals Australia Pt...

    Country
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    Takeda Pharmaceuticals Australia Pt...

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    Regulatory Info :

    Registration Country : Australia

    teduglutide

    Brand Name : Revestive

    Dosage Form :

    Dosage Strength :

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    11

    Takeda Pharmaceuticals Australia Pt...

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    Takeda Pharmaceuticals Australia Pt...

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    Regulatory Info :

    Registration Country : Australia

    teduglutide

    Brand Name : Revestive

    Dosage Form :

    Dosage Strength :

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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