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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Brightgene Bio-medical Technology Co.,ltd

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    BrightGene Bio-Medical Technology Co.,Ltd

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    01 Amphotericin B (1)

    02 Anidulafungin (1)

    03 Ansamitocin P3 (1)

    04 Apalutamide (1)

    05 Argatroban (4)

    06 CAS 184177-83-1 (1)

    07 CAS-149809-43-8 (1)

    08 Cabergoline (1)

    09 Carboprost Tromethamine (1)

    10 Caspofungin (1)

    11 Dalbavancin (4)

    12 Dienogest (1)

    13 Doramectin (1)

    14 Dydrogesterone (1)

    15 Eldecalcitol (1)

    16 Emodepside (1)

    17 Entecavir (1)

    18 Entecavir Intermediate VIII Isomer (1)

    19 Entecavir Monohydrate (1)

    20 Eribulin (1)

    21 Everolimus (2)

    22 Exatecan (1)

    23 Ferric Carboxymaltose (1)

    24 Ferric Pyrophosphate Citrate (1)

    25 Fidaxomicin (2)

    26 Fluralaner (1)

    27 Fondaparinux Sodium (3)

    28 Gadobutrol (1)

    29 Hydroxy Echinocandin (1)

    30 Ibrexafungerp Citrate (1)

    31 Iodixanol (1)

    32 Iomeprol (1)

    33 Iopromide (1)

    34 Iron Sucrose (1)

    35 Isavuconazonium Sulfate (1)

    36 Josamycin (1)

    37 Laninamivir Octanoate (1)

    38 Lurbinectedin (1)

    39 Maytansinoid DM1 (2)

    40 Micafungin (3)

    41 Midostaurin (1)

    42 Molnupiravir (1)

    43 Mycophenolate Sodium (1)

    44 Nicergoline (2)

    45 Nystatin (1)

    46 Obeticholic Acid (1)

    47 Omadacycline (1)

    48 Oritavancin (1)

    49 Oseltamivir Phosphate (1)

    50 Pemetrexed (1)

    51 Pimecrolimus (2)

    52 Posaconazole (4)

    53 Regadenoson Monohydrate (1)

    54 Relugolix (1)

    55 Sirolimus (1)

    56 Spinosyn D (1)

    57 Staurosporine (1)

    58 Sugammadex Sodium (1)

    59 Tacrolimus (1)

    60 Trabectedin (1)

    61 Trientine Hydrochloride (1)

    62 Voclosporin (1)

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    01 Active (48)

    02 Blank (32)

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    01 Valid (5)

    02 Blank (75)

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    01 228MF10118 (1)

    02 230MF10023 (1)

    03 230MF10028 (1)

    04 230MF10169 (1)

    05 302MF10033 (1)

    06 303MF10069 (1)

    07 304MF10018 (1)

    08 304MF10030 (1)

    09 305MF10018 (1)

    10 305MF10140 (1)

    11 Blank (70)

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    01 Blank (80)

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    • FDA
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    Entecavir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31949
    Active
    ENTECAVIR MONOHYDRATE
    2017-08-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-283 - Rev 00
    Valid
    Entecavir monohydrate
    2020-06-19
    Japanese DMF

    Found JDMF

    228MF10118
    Entecavir intermediate (ET1) at Bui...
    2016-06-24
    Written Confirmation

    Close WC

    Application Number
    31949
    R0-CEP 2018-283 - Rev 00
    228MF10118
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ENTECAVIR MONOHYDRATE
    Entecavir monohydrate
    Entecavir intermediate (ET1) at Bui...
    Issue/Submission Date
    2017-08-23
    2020-06-19
    2016-06-24
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    Everolimus

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    USDMF

    Found USDMF

    32020
    Active
    EVEROLIMUS (NON-STERILE API)
    2017-09-20
    CEP/COS

    Found CEP/COS

    CEP 2022-367 - Rev 00
    Valid
    Everolimus, Butylated hydroxytoluen...
    2024-02-15
    Japanese DMF

    Found JDMF

    230MF10023
    Everolimus at Building C25-C28, No....
    2018-02-14
    Written Confirmation

    Close WC

    Application Number
    32020
    CEP 2022-367 - Rev 00
    230MF10023
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EVEROLIMUS (NON-STERILE API)
    Everolimus, Butylated hydroxytoluen...
    Everolimus at Building C25-C28, No....
    Issue/Submission Date
    2017-09-20
    2024-02-15
    2018-02-14
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    Argatroban

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    USDMF

    Found USDMF

    35491
    Active
    ARGATROBAN
    2020-12-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10140
    Argatroban at Building C25-C28, No....
    2023-12-22
    Written Confirmation

    Close WC

    Application Number
    35491
    305MF10140
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARGATROBAN
    Argatroban at Building C25-C28, No....
    Issue/Submission Date
    2020-12-26
    2023-12-22
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    Eribulin

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    USDMF

    Found USDMF

    35118
    Active
    ERIBULIN MESYLATE
    2020-10-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10030
    Eribulin Mesylate at Building C25-C...
    2022-02-10
    Written Confirmation

    Close WC

    Application Number
    35118
    304MF10030
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERIBULIN MESYLATE
    Eribulin Mesylate at Building C25-C...
    Issue/Submission Date
    2020-10-28
    2022-02-10
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    Micafungin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30028
    Active
    MICAFUNGIN SODIUM INTERMEDIATE A
    2015-11-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10169
    MICAFUNGIN SODIUM at Building C25-C...
    2018-12-19
    Written Confirmation

    Close WC

    Application Number
    30028
    230MF10169
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MICAFUNGIN SODIUM INTERMEDIATE A
    MICAFUNGIN SODIUM at Building C25-C...
    Issue/Submission Date
    2015-11-11
    2018-12-19
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    Micafungin

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    USDMF

    Found USDMF

    31449
    Active
    MICAFUNGIN SODIUM (NON-STERILE, API...
    2017-03-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10069
    Micafungin Sodium (TMC) at Building...
    2021-04-19
    Written Confirmation

    Close WC

    Application Number
    31449
    303MF10069
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MICAFUNGIN SODIUM (NON-STERILE, API...
    Micafungin Sodium (TMC) at Building...
    Issue/Submission Date
    2017-03-03
    2021-04-19
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    Oseltamivir Phosphate

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    USDMF

    Found USDMF

    35876
    Active
    OSELTAMIVIR PHOSPHATE
    2021-04-29
    CEP/COS

    Found CEP/COS

    CEP 2022-488 - Rev 00
    Valid
    Oseltamivir phosphate
    2024-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35876
    CEP 2022-488 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OSELTAMIVIR PHOSPHATE
    Oseltamivir phosphate
    Issue/Submission Date
    2021-04-29
    2024-03-07
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    Sugammadex Sodium

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    USDMF

    Found USDMF

    33904
    Active
    SUGAMMADEX SODIUM (NON-STERILE, API...
    2019-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10018
    Sugammadex Sodium at Building C25-C...
    2023-02-02
    Written Confirmation

    Close WC

    Application Number
    33904
    305MF10018
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUGAMMADEX SODIUM (NON-STERILE, API...
    Sugammadex Sodium at Building C25-C...
    Issue/Submission Date
    2019-06-06
    2023-02-02
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    Anidulafungin

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    USDMF

    Found USDMF

    32010
    Active
    ANIDULAFUNGIN (NON-STERILE API)
    2017-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32010
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ANIDULAFUNGIN (NON-STERILE API)
    Issue/Submission Date
    2017-08-28
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    Ansamitocin P3

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    USDMF

    Found USDMF

    34434
    Active
    ANSAMITOCIN P-3
    2019-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34434
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ANSAMITOCIN P-3
    Issue/Submission Date
    2019-12-23
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