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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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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    26540
    Active
    ROSUVASTATIN CALCIUM
    2012-10-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-040 - Rev 00
    Valid
    Rosuvastatin calcium
    2020-12-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Rosuvastatin Calcium
    2022-04-13
    Application Number
    26540
    R1-CEP 2015-040 - Rev 00
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium
    Rosuvastatin Calcium
    Issue/Submission Date
    2012-10-11
    2020-12-10
    2022-04-13
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    • FDA
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    27675
    Active
    ROSUVASTATIN CALCIUM (PRODUCT CODE ...
    2013-10-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-114 - Rev 02
    Valid
    Rosuvastatin calcium, Process I
    2023-01-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038
    Expired
    Rosuvastatin Calcium IH/USP/EP
    2019-09-09
    Application Number
    27675
    R1-CEP 2015-114 - Rev 02
    Indian CDSCO WC-0038
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-04
    Filing Details
    ROSUVASTATIN CALCIUM (PRODUCT CODE ...
    Rosuvastatin calcium, Process I
    Rosuvastatin Calcium IH/USP/EP
    Issue/Submission Date
    2013-10-08
    2023-01-27
    2019-09-09
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