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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Evonik Health Care is the innovation hub for leading life science companies

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

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    tetrahydro-6-biopterin

    ACTIVE PHARMA INGREDIENTS

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    01 1AUROBINDO PHARMA ITALIA SRL

    02 1Aurobindo Pharma (Malta) Limited

    03 1Aurovitas Spain, Sau

    04 2BIOMARIN INTERNATIONAL LIMITED

    05 2BioMarin International Limited

    06 10Biomarin International Limited

    07 3DIPHARMA ARZNEIMITTEL GMBH

    08 4Dipharma Arzneimittel GmbH

    09 12Dipharma Arzneimittel Gmbh

    10 3Dipharma Sa

    11 1Drac Ag

    12 1Nobel Pharma Schweiz Ag

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    14 1Sandoz A/S

    15 1Spirig Healthcare Ag

    16 2Stada Pharmaceuticals Ag

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    01

    AUROBINDO PHARMA ITALIA SRL

    India
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    AUROBINDO PHARMA ITALIA SRL

    India
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    Regulatory Info :

    Registration Country : Italy

    Sapropterin

    Brand Name : SAPROPTERINA AUROBINDO

    Dosage Form : Soluble Tablets

    Dosage Strength : 100 mg

    Packaging : 120 UNITS 100 MG - ORAL USE

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    Regulatory Info :

    Registration Country : Italy

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    02

    Aurobindo Pharma (Malta) Limited

    India
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    Aurobindo Pharma (Malta) Limited

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Sapropterin Dihydrochloride

    Brand Name : Sapropterin Aurobindo

    Dosage Form : Orodispersible Tablet

    Dosage Strength : 100mg

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    Approval Date : 19-04-2023

    Application Number : 2.02E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    03

    BIOMARIN INTERNATIONAL LIMITED

    U.S.A
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    BIOMARIN INTERNATIONAL LIMITED

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    Regulatory Info :

    Registration Country : Italy

    Sapropterin

    Brand Name : KUVAN

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 120 UNITS 100 MG - ORAL USE

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    Regulatory Info :

    Registration Country : Italy

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    04

    BIOMARIN INTERNATIONAL LIMITED

    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    Sapropterin

    Brand Name : KUVAN

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 30 UNITS 100 MG - ORAL USE

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    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    05

    BioMarin International Limited

    U.S.A
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    Regulatory Info : Not Marketed

    Registration Country : Norway

    Sapropterin dihydrochloride

    Brand Name : Kuvan

    Dosage Form : Orodispersible Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Not Marketed

    Registration Country : Norway

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    06

    BioMarin International Limited

    U.S.A
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    Regulatory Info : Not Marketed

    Registration Country : Norway

    Sapropterin dihydrochloride

    Brand Name : Kuvan

    Dosage Form : Orodispersible Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Not Marketed

    Registration Country : Norway

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    07

    Biomarin International Limited

    U.S.A
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    Biomarin International Limited

    U.S.A
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Sapropterin

    Brand Name : Kuvan

    Dosage Form : Orodispersible Tablet

    Dosage Strength : 100mg

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    Approval Date :

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    Regulatory Info :

    Registration Country : Italy

    Tetrahydrobiopterin

    Brand Name : Kuvan

    Dosage Form : Sapropterina 100Mg 120 Unita' Oral Use

    Dosage Strength : 120 cpr solub 100 mg

    Packaging :

    Approval Date :

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    Regulatory Info :

    Registration Country : Italy

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    09

    Country
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    Regulatory Info :

    Registration Country : Italy

    Tetrahydrobiopterin

    Brand Name : Kuvan

    Dosage Form : Sapropterina 100Mg 30 Joined' Oral Use

    Dosage Strength : 30 cpr solub 100 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Aurovitas Spain, Sau

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    Regulatory Info : Authorized

    Registration Country : Spain

    Sapropterin Hydrochloride

    Brand Name : Sapropterina Aurovitas

    Dosage Form : Soluble Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 23-03-2023

    Application Number : 88742

    Regulatory Info : Authorized

    Registration Country : Spain

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