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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Ningbo Menovo Pharmaceutical

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    01 Apixaban (1)

    02 Atorvastatin (1)

    03 Esomeprazole Magnesium (2)

    04 Fipronil (1)

    05 Losartan Potassium (1)

    06 Perindopril Erbumine (1)

    07 Rosuvastatin Calcium (2)

    08 Valsartan (2)

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    01 Active (2)

    02 Inactive (3)

    03 Blank (6)

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    01 Valid (9)

    02 Withdrawn by Holder (1)

    03 Blank (1)

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    01 227MF10137 (1)

    02 304MF10130 (1)

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    01 Blank (11)

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    Valsartan

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    USDMF

    Caution USDMF

    33254
    Inactive
    VALSARTAN
    2018-10-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-258 - Rev 00
    Valid
    Valsartan
    2021-02-05
    Japanese DMF

    Found JDMF

    304MF10130
    Valsartan at 12B/F, Building 1, Nin...
    2022-09-08
    Written Confirmation

    Close WC

    Application Number
    33254
    R0-CEP 2019-258 - Rev 00
    304MF10130
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    VALSARTAN
    Valsartan
    Valsartan at 12B/F, Building 1, Nin...
    Issue/Submission Date
    2018-10-10
    2021-02-05
    2022-09-08
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    Perindopril Erbumine

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2022-207 - Rev 00
    Valid
    Perindopril tert-butylamine
    2024-02-28
    Japanese DMF

    Found JDMF

    227MF10137
    Perindopril erbumine at 12B/F, Buil...
    2015-05-14
    Written Confirmation

    Close WC

    Application Number
    CEP 2022-207 - Rev 00
    227MF10137
    Status
    Valid
     
    Filing Details
    Perindopril tert-butylamine
    Perindopril erbumine at 12B/F, Buil...
    Issue/Submission Date
    2024-02-28
    2015-05-14
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    38661
    Active
    ROSUVASTATIN CALCIUM INTERMEDIATE
    2023-08-18
    CEP/COS

    Found CEP/COS

    CEP 2023-095 - Rev 01
    Valid
    Rosuvastatin calcium, Process II
    2023-11-17
    Japanese DMF

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    Written Confirmation

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    Application Number
    38661
    CEP 2023-095 - Rev 01
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    ROSUVASTATIN CALCIUM INTERMEDIATE
    Rosuvastatin calcium, Process II
    Issue/Submission Date
    2023-08-18
    2023-11-17
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    Esomeprazole Magnesium

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    USDMF

    Caution USDMF

    33253
    Inactive
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    2018-10-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-166 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    33253
    R1-CEP 2016-166 - Rev 00
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    Esomeprazole magnesium dihydrate
    Issue/Submission Date
    2018-10-10
    2022-08-24
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    Rosuvastatin Calcium

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    USDMF

    Caution USDMF

    33481
    Inactive
    ROSUVASTATIN CALCIUM
    2019-01-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-012 - Rev 03
    Valid
    Rosuvastatin calcium
    2021-03-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33481
    R0-CEP 2019-012 - Rev 03
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium
    Issue/Submission Date
    2019-01-15
    2021-03-26
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    Apixaban

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    USDMF

    Found USDMF

    34071
    Active
    APIXABAN
    2019-09-30
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    34071
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2019-09-30
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-013 - Rev 00
    Valid
    Atorvastatin calcium
    2020-09-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-013 - Rev 00
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium
    Issue/Submission Date
    2020-09-24
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    Esomeprazole Magnesium

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2018-001 - Rev 01
    Valid
    Esomeprazole magnesium trihydrate
    2019-09-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2018-001 - Rev 01
    Status
    Valid
     
    Filing Details
    Esomeprazole magnesium trihydrate
    Issue/Submission Date
    2019-09-05
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    Fipronil

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-020 - Rev 00
    Valid
    Fipronil for veterinary use
    2022-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-020 - Rev 00
    Status
    Valid
     
    Filing Details
    Fipronil for veterinary use
    Issue/Submission Date
    2022-12-14
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    Losartan Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-344 - Rev 00
    Valid
    Losartan potassium, New process
    2022-03-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-344 - Rev 00
    Status
    Valid
     
    Filing Details
    Losartan potassium, New process
    Issue/Submission Date
    2022-03-04
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