Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Sterling Biotech

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    Simvastatin

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    USDMF

    Caution USDMF

    30836
    Inactive
    SIMVASTATIN AMMONIUM SALT (INTERMED...
    2016-07-18
    CEP/COS

    Caution CEP/COS

    R0-CEP 2015-300 - Rev 00
    Withdrawn by Holder
    Simvastatin
    2016-10-27
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    Application Number
    30836
    R0-CEP 2015-300 - Rev 00
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    SIMVASTATIN AMMONIUM SALT (INTERMED...
    Simvastatin
    Issue/Submission Date
    2016-07-18
    2016-10-27
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    • WHO-GMP
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    Simvastatin

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    USDMF

    Caution USDMF

    30837
    Inactive
    SIMVASTATIN USP
    2016-07-20
    CEP/COS

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    Japanese DMF

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    Application Number
    30837
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    SIMVASTATIN USP
    Issue/Submission Date
    2016-07-20
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