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    Sapropterin Hydrochloride

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    Hopewell`s Generics Sapropterin 2HCl Receives Approval in US
    Hopewell`s Generics Sapropterin 2HCl Receives Approval in US

    03 Sep 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216432

    FDA
    03 Sep 2025
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    Zenara`s Generics Sapropterin Receives Approval in US
    Zenara`s Generics Sapropterin Receives Approval in US

    11 Jun 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218797

    FDA
    11 Jun 2025
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    Enforcement Report - Week of December 18, 2024
    Enforcement Report - Week of December 18, 2024

    18 Dec 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-18-2024-87175.pdf

    FDA
    18 Dec 2024
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    Enforcement Report - Week of May 15, 2024
    Enforcement Report - Week of May 15, 2024

    15 May 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-15-2024-59166.pdf

    FDA
    15 May 2024
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    Health Canada Issues Recall of Dr. Reddy's Sapropterin
    Health Canada Issues Recall of Dr. Reddy's Sapropterin

    03 May 2024

    // HEALTH CANADA

    https://recalls-rappels.canada.ca/en/alert-recall/reddy-sapropterin-color-change-decrease-potency

    HEALTH CANADA
    03 May 2024
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    Health Canada Issues Recall of Dr. Reddy's Lab Canada's Sapropterin
    Health Canada Issues Recall of Dr. Reddy's Lab Canada's Sapropterin

    03 May 2024

    // HEALTH CANADA

    https://recalls-rappels.canada.ca/en/alert-recall/reddy-sapropterin-color-change-decrease-potency

    HEALTH CANADA
    03 May 2024
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