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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Topharman Shandong Co Ltd

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    TOPHARMAN SHANDONG CO LTD

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    PharmaCompass

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    01 Aripiprazole (1)

    02 Brexpiprazole (1)

    03 Dapoxetine Hydrochloride (1)

    04 Efinaconazole (1)

    05 Neratinib (1)

    06 Rivaroxaban (1)

    07 Sofosbuvir (1)

    08 Tadalafil (1)

    09 Telmisartan (1)

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    01 Active (9)

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    01 Valid (1)

    02 Blank (8)

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    01 228MF10071 (1)

    02 231MF10002 (1)

    03 303MF10143 (1)

    04 Blank (6)

    filter

    01 Blank (9)

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    Tadalafil

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    USDMF

    Found USDMF

    33012
    Active
    TADALAFIL
    2018-08-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-179 - Rev 01
    Valid
    Tadalafil
    2020-09-03
    Japanese DMF

    Found JDMF

    231MF10002
    Tadalafil at 49 Wenshuibeilu, Xin'...
    2019-01-10
    Written Confirmation

    Close WC

    Application Number
    33012
    R0-CEP 2018-179 - Rev 01
    231MF10002
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    TADALAFIL
    Tadalafil
    Tadalafil at 49 Wenshuibeilu, Xin'...
    Issue/Submission Date
    2018-08-10
    2020-09-03
    2019-01-10
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    Aripiprazole

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    USDMF

    Found USDMF

    28563
    Active
    ARIPIPRAZOLE
    2014-09-16
    CEP/COS

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    Japanese DMF

    Found JDMF

    303MF10143
    Aripiprazole at 49 Wenshuibeilu, X...
    2021-09-02
    Written Confirmation

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    Application Number
    28563
    303MF10143
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    ARIPIPRAZOLE
    Aripiprazole at 49 Wenshuibeilu, X...
    Issue/Submission Date
    2014-09-16
    2021-09-02
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    Telmisartan

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    USDMF

    Found USDMF

    28309
    Active
    TELMISARTAN
    2014-05-22
    CEP/COS

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    Japanese DMF

    Found JDMF

    228MF10071
    Telmisartan at 49 Wenshuibeilu, Xi...
    2016-03-02
    Written Confirmation

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    Application Number
    28309
    228MF10071
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    TELMISARTAN
    Telmisartan at 49 Wenshuibeilu, Xi...
    Issue/Submission Date
    2014-05-22
    2016-03-02
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    Brexpiprazole

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    USDMF

    Found USDMF

    36360
    Active
    BREXPIPRAZOLE
    2022-06-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    36360
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    BREXPIPRAZOLE
    Issue/Submission Date
    2022-06-15
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    Dapoxetine Hydrochloride

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    USDMF

    Found USDMF

    37627
    Active
    DAPOXETINE HYDROCHLORIDE
    2022-10-26
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    37627
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DAPOXETINE HYDROCHLORIDE
    Issue/Submission Date
    2022-10-26
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    Efinaconazole

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    USDMF

    Found USDMF

    32479
    Active
    EFINACONAZOLE
    2018-02-02
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    32479
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    EFINACONAZOLE
    Issue/Submission Date
    2018-02-02
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    Neratinib

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    USDMF

    Found USDMF

    37407
    Active
    NERATINIB MALEATE
    2022-08-29
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    37407
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    NERATINIB MALEATE
    Issue/Submission Date
    2022-08-29
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    Rivaroxaban

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    USDMF

    Found USDMF

    35602
    Active
    RIVAROXABAN
    2021-02-04
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    35602
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    RIVAROXABAN
    Issue/Submission Date
    2021-02-04
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    Sofosbuvir

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    USDMF

    Found USDMF

    29576
    Active
    1-((2R,3R,4R,5R)-3-FLUORO-4-HYDROXY...
    2015-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    29576
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    1-((2R,3R,4R,5R)-3-FLUORO-4-HYDROXY...
    Issue/Submission Date
    2015-08-31
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