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    01 1Zenara Pharma

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    01

    Zenara Pharma

    India
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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2025-06-11

    Application Number : 218797

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    Dr. Reddy's Laboratories

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2021-06-15

    Application Number : 207685

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    Aucta Pharmaceuticals

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : ZELVYSIA

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    Approval Date : 2025-04-29

    Application Number : 218645

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    Dr. Reddy's Laboratories

    India
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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

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    Approval Date : 2021-03-30

    Application Number : 209452

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    Dr. Reddy's Laboratories

    India
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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

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    Approval Date : 2022-05-13

    Application Number : 215798

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    Aucta Pharmaceuticals

    U.S.A
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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : ZELVYSIA

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    Dosage Strength : 500MG/PACKET

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    Approval Date : 2025-04-29

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    07

    Annora Pharma

    India
    Peptide Process CMC
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    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

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    Approval Date : 2022-08-18

    Application Number : 215420

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    08

    Annora Pharma

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    Dosage Strength : 500MG/PACKET

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    Approval Date : 2022-08-18

    Application Number : 215420

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    09

    Annora Pharma

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    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2022-08-23

    Application Number : 215534

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    10

    Aurobindo Pharma Limited

    India
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    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2025-06-09

    Application Number : 216797

    Regulatory Info : RX

    Registration Country : USA

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    11

    BioMarin Pharmaceutical

    U.S.A
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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : KUVAN

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2007-12-13

    Application Number : 22181

    Regulatory Info : RX

    Registration Country : USA

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    12

    BioMarin Pharmaceutical

    U.S.A
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    U.S.A
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    Brand Name : KUVAN

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

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    Approval Date : 2013-12-19

    Application Number : 205065

    Regulatory Info : RX

    Registration Country : USA

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    13

    BioMarin Pharmaceutical

    U.S.A
    Peptide Process CMC
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    BioMarin Pharmaceutical

    U.S.A
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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : KUVAN

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

    Packaging :

    Approval Date : 2015-10-27

    Application Number : 205065

    Regulatory Info : RX

    Registration Country : USA

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    14

    BioMarin Pharmaceutical

    U.S.A
    Peptide Process CMC
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    Registration Country : Sweden

    sapropterin dihydrochloride

    Brand Name : Kuvan

    Dosage Form : SOLUBLE TABLET

    Dosage Strength : 100 MG

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    Registration Country : Sweden

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    15

    Dipharma

    Italy
    Peptide Process CMC
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    Dipharma

    Italy
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    sapropterin 2HCl

    Brand Name : Diterin

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    Dosage Strength : 100mg

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    Registration Country : Italy

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    16

    PH HEALTH

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2019-05-10

    Application Number : 207200

    Regulatory Info : RX

    Registration Country : USA

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    17

    PH HEALTH

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    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

    Packaging :

    Approval Date : 2019-08-20

    Application Number : 207207

    Regulatory Info : RX

    Registration Country : USA

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    18

    PH HEALTH

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    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

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    Approval Date : 2019-08-20

    Application Number : 210027

    Regulatory Info : RX

    Registration Country : USA

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    Tetrahydrobiopterin

    Brand Name : Kuvan

    Dosage Form : Sapropterina 100Mg 120 Unita' Oral Use

    Dosage Strength : 120 cpr solub 100 mg

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    Country
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    Tetrahydrobiopterin

    Brand Name : Kuvan

    Dosage Form : Sapropterina 100Mg 30 Joined' Oral Use

    Dosage Strength : 30 cpr solub 100 mg

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    Registration Country : Italy

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