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

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    Bandra (East)Mumbai - 400051
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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    24858
    Active
    DOXORUBICIN HYDROCHLORIDE(API)
    2011-04-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-039 - Rev 01
    Valid
    Doxorubicin Hydrochloride
    2020-01-02
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0292
    Expired
    Doxorubicin Hydrochloride (Ph.Eur) ...
    2020-12-18
    Application Number
    24858
    R1-CEP 2012-039 - Rev 01
    Indian CDSCO WC-0292
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2023-12-17
    Filing Details
    DOXORUBICIN HYDROCHLORIDE(API)
    Doxorubicin Hydrochloride
    Doxorubicin Hydrochloride (Ph.Eur) ...
    Issue/Submission Date
    2011-04-05
    2020-01-02
    2020-12-18
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    Lovastatin

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    USDMF

    Found USDMF

    24859
    Active
    LOVASTATIN(API)
    2011-04-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-146 - Rev 00
    Valid
    Lovastatin
    2020-03-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0292
    Expired
    Lovastatin (Ph.Eur) at Jambusar Sta...
    2020-12-18
    Application Number
    24859
    R1-CEP 2014-146 - Rev 00
    Indian CDSCO WC-0292
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2023-12-17
    Filing Details
    LOVASTATIN(API)
    Lovastatin
    Lovastatin (Ph.Eur) at Jambusar Sta...
    Issue/Submission Date
    2011-04-07
    2020-03-16
    2020-12-18
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    Epirubicin Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-349 - Rev 00
    Valid
    Epirubicin hydrochloride
    2022-06-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0292
    Expired
    Epirubicin Hydrochloride (Ph.Eur) a...
    2020-12-18
    Application Number
    R1-CEP 2015-349 - Rev 00
    Indian CDSCO WC-0292
    Status
    Valid
     
    Expired
    2023-12-17
    Filing Details
    Epirubicin hydrochloride
    Epirubicin Hydrochloride (Ph.Eur) a...
    Issue/Submission Date
    2022-06-07
    2020-12-18
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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
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    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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    Daunorubicin HCl

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0292
    Expired
    Daunorubicine Hydrochloride (Ph.Eur...
    2020-12-18
    Application Number
    Indian CDSCO WC-0292
    Status
     
    Expired
    2023-12-17
    Filing Details
    Daunorubicine Hydrochloride (Ph.Eur...
    Issue/Submission Date
    2020-12-18
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    Simvastatin

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    USDMF

    Caution USDMF

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

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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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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    Mycophenolic Acid

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    USDMF

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    CEP/COS

    Close CEP/COS

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