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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Lek Pharmaceuticals

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    Lek Pharmaceuticals
    Slovenia Flag
    Country
    Country
    Slovenia
    Address
    Address
    Verovkova 57, 1526 Ljubljana
    Telephone
    Telephone
    +386 1 580 21 11
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    enquiries@pharmacompass.com
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    https://lek.si/en/
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    20765
    Active
    ROSUVASTATIN CALCIUM
    2007-08-09
    CEP/COS

    Caution CEP/COS

    R0-CEP 2016-321 - Rev 01
    Withdrawn by Holder
    Rosuvastatin calcium, Process C
    2019-04-15
    Japanese DMF

    Found JDMF

    228MF10155
    Rosuvastatin calcium at Verovskova ...
    2016-08-08
    Written Confirmation

    Close WC

    Application Number
    20765
    R0-CEP 2016-321 - Rev 01
    228MF10155
    Status
    Active
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium, Process C
    Rosuvastatin calcium at Verovskova ...
    Issue/Submission Date
    2007-08-09
    2019-04-15
    2016-08-08
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    30932
    Active
    ROSUVASTATIN CALCIUM (PROCESS C)
    2016-12-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30932
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    ROSUVASTATIN CALCIUM (PROCESS C)
    Issue/Submission Date
    2016-12-01
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    Rosuvastatin Calcium

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    USDMF

    Caution USDMF

    28022
    Inactive
    ROSUVASTATIN CALCIUM (PROCESS B)
    2014-05-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28022
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ROSUVASTATIN CALCIUM (PROCESS B)
    Issue/Submission Date
    2014-05-08
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