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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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    Fluvastatin Sodium

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    USDMF

    Found USDMF

    18493
    Active
    FLUVASTATIN SODIUM AMORPHOUS
    2005-07-07
    CEP/COS

    Found CEP/COS

    CEP 2018-182 - Rev 02
    Valid
    Fluvastatin sodium, Crystalline
    2024-03-25
    Japanese DMF

    Found JDMF

    225MF10102
    Fluvastatin sodium at 20th K. M. Ho...
    2013-05-13
    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Fluvastatin Sodium (EP)
    2022-04-13
    Application Number
    18493
    CEP 2018-182 - Rev 02
    225MF10102
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FLUVASTATIN SODIUM AMORPHOUS
    Fluvastatin sodium, Crystalline
    Fluvastatin sodium at 20th K. M. Ho...
    Fluvastatin Sodium (EP)
    Issue/Submission Date
    2005-07-07
    2024-03-25
    2013-05-13
    2022-04-13
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    Fluvastatin Sodium

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    USDMF

    Found USDMF

    18762
    Active
    FLUVASTATIN SODIUM
    2005-09-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-130 - Rev 01
    Valid
    Fluvastatin sodium, Crystalline-2
    2022-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18762
    R0-CEP 2022-130 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLUVASTATIN SODIUM
    Fluvastatin sodium, Crystalline-2
    Issue/Submission Date
    2005-09-13
    2022-06-23
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    Fluvastatin Sodium

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    USDMF

    Found USDMF

    36735
    Active
    FLUVASTATIN SODIUM
    2022-02-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-139 - Rev 01
    Valid
    Fluvastatin sodium, Amorphous-2
    2022-08-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36735
    R0-CEP 2022-139 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUVASTATIN SODIUM
    Fluvastatin sodium, Amorphous-2
    Issue/Submission Date
    2022-02-28
    2022-08-08
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    Fluvastatin Sodium

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    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-075 - Rev 00
    Valid
    Fluvastatin sodium, Amorphous
    2022-10-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-075 - Rev 00
    Status
    Valid
     
    Filing Details
    Fluvastatin sodium, Amorphous
    Issue/Submission Date
    2022-10-14
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