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    CAS-69056-38-8

    ACTIVE PHARMA INGREDIENTS

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    01 1AUROBINDO PHARMA ITALIA SRL

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    04 2BIOMARIN INTERNATIONAL LIMITED

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    06 10Biomarin International Limited

    07 3DIPHARMA ARZNEIMITTEL GMBH

    08 4Dipharma Arzneimittel GmbH

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    AUROBINDO PHARMA ITALIA SRL

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    Sapropterin

    Brand Name : SAPROPTERINA AUROBINDO

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    Regulatory Info : Deregistered

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    Sapropterin Dihydrochloride

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    Approval Date : 19/04/2023

    Application Number : 20220104000049

    Regulatory Info : Deregistered

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    Brand Name : Kuvan

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    Regulatory Info : Approved

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    Sapropterin Dihydrochloride

    Brand Name : The Cow

    Dosage Form : Orodispersible Tablet

    Dosage Strength : 100mg

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    Approval Date : 02/12/2008

    Application Number : 20071130000080

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    Regulatory Info : Approved

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    Sapropterin Dihydrochloride

    Brand Name : The Cow

    Dosage Form : Powder For Oral Solution

    Dosage Strength : 100mg

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    Approval Date : 13/07/2017

    Application Number : 20161109000071

    Regulatory Info : Approved

    Registration Country : Sweden

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    Biomarin International Limited

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    Regulatory Info : Approved

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    Sapropterin Dihydrochloride

    Brand Name : The Cow

    Dosage Form : Powder For Oral Solution

    Dosage Strength : 500mg

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    Approval Date : 13/07/2017

    Application Number : 20161109000088

    Regulatory Info : Approved

    Registration Country : Sweden

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    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

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    Approval Date : 23-03-2023

    Application Number : 88742

    Regulatory Info : Authorized

    Registration Country : Spain

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