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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Biocon Limited

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    Hosur Road,Electronics City,Bangalore
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    Simvastatin

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    USDMF

    Found USDMF

    18449
    Active
    SIMVASTATIN
    2005-06-23
    CEP/COS

    Found CEP/COS

    CEP 2012-337 - Rev 03
    Valid
    Simvastatin
    2024-01-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Simvastatin (Ph.Eur/USP)
    2019-07-22
    Application Number
    18449
    CEP 2012-337 - Rev 03
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    SIMVASTATIN
    Simvastatin
    Simvastatin (Ph.Eur/USP)
    Issue/Submission Date
    2005-06-23
    2024-01-26
    2019-07-22
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    Simvastatin

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    USDMF

    Caution USDMF

    16094
    Inactive
    SIMVASTATIN USP
    2002-08-12
    CEP/COS

    Found CEP/COS

    CEP 2003-131 - Rev 12
    Valid
    Simvastatin, Butylated Hydroxyaniso...
    2023-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Simvastatin (EP/USP)
    2022-04-13
    Application Number
    16094
    CEP 2003-131 - Rev 12
    Indian CDSCO WC-0109
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    SIMVASTATIN USP
    Simvastatin, Butylated Hydroxyaniso...
    Simvastatin (EP/USP)
    Issue/Submission Date
    2002-08-12
    2023-11-08
    2022-04-13
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    Simvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-388 - Rev 02
    Withdrawn by Holder
    Simvastatin
    2012-11-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0109A3
    Expired
    Simvastatin EP/USP
    2019-10-30
    Application Number
    R1-CEP 2001-388 - Rev 02
    Indian CDSCO WC-0109A3
    Status
    Withdrawn by Holder
     
    Expired
    2022-07-02
    Filing Details
    Simvastatin
    Simvastatin EP/USP
    Issue/Submission Date
    2012-11-22
    2019-10-30
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    Simvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-243 - Rev 00
    Withdrawn by Holder
    Simvastatin, Butylated hydroxyaniso...
    2012-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-243 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Simvastatin, Butylated hydroxyaniso...
    Issue/Submission Date
    2012-02-28
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