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    Sapropterin Hydrochloride

    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 1BioMarin International Limited

    06 4Biomarin International Limited

    07 3DIPHARMA ARZNEIMITTEL GMBH

    08 4Dipharma Arzneimittel GmbH

    09 6Dipharma Arzneimittel Gmbh

    10 3Dipharma Sa

    11 1Drac Ag

    12 1Nobel Pharma Schweiz Ag

    13 1Orifarm AS

    14 1PIAM FARMACEUTICI SPA

    15 1Spirig Healthcare Ag

    16 1Stada Pharmaceuticals Ag

    17 1Stada Sl Laboratory

    18 1Tarbis Farma Sl

    19 1Teva Gmbh

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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

    BioMarin International Limited

    U.S.A
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    Regulatory Info :

    Registration Country : Norway

    Sapropterin Dihydrochloride

    Brand Name : Kuvan

    Dosage Form : Soluble Antic-Calc tablet

    Dosage Strength : 100 mg

    Packaging : Bottle

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    Regulatory Info :

    Registration Country : Norway

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    03

    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 : 120 UNITS 100 MG - ORAL USE

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    Registration Country : Italy

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    04

    BIOMARIN INTERNATIONAL LIMITED

    U.S.A
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    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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    Regulatory Info :

    Registration Country : Italy

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    05

    DIPHARMA ARZNEIMITTEL GMBH

    Italy
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    Italy
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    Registration Country : Italy

    Sapropterin

    Brand Name : SAPROPTERIN DIPHARMA

    Dosage Form : Powder For Oral Solution Oral

    Dosage Strength : 100 mg

    Packaging : 30 UNITS 100 MG - ORAL USE

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    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    06

    DIPHARMA ARZNEIMITTEL GMBH

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Sapropterin

    Brand Name : SAPROPTERIN DIPHARMA

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 120 UNITS 100 MG - ORAL USE

    Approval Date :

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    Regulatory Info :

    Registration Country : Italy

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    07

    DIPHARMA ARZNEIMITTEL GMBH

    Italy
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    DIPHARMA ARZNEIMITTEL GMBH

    Italy
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    Sapropterin

    Brand Name : SAPROPTERIN DIPHARMA

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 30 UNITS 100 MG - ORAL USE

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    Registration Country : Italy

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    PIAM FARMACEUTICI SPA

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    Registration Country : Italy

    Sapropterin

    Brand Name : ARPETRAN

    Dosage Form : Soluble Tablets

    Dosage Strength : 100 mg

    Packaging : 120 UNITS 100 MG - ORAL USE

    Approval Date :

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    Regulatory Info :

    Registration Country : Italy

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    Country
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    Registration Country : Italy

    Tetrahydrobiopterin

    Brand Name : Kuvan

    Dosage Form : Sapropterina 100Mg 120 Unita' Oral Use

    Dosage Strength : 120 cpr solub 100 mg

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    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

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    Approval Date :

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    Regulatory Info :

    Registration Country : Italy

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