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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Brightgene Bio-medical Technology Co.,ltd to the U.S. FDA. Original Data : FDA Website

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    01 ((3S,5R)-5-((1H-1,2,4-TRIAZOL-1-YL)METHYL)-5-(2,4-DIFLUOROPHENYL)TETRAHYDROFURAN-3-YL)METHYL 4-METHYLBENZENESULFONATE(POSACONAZOLE INTERMEDIATE POA) (1)

    02 2-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4-(BENZYLOXY)-3-(BENZYLOXYMETHYL)-2-METHYLENE CYCLOPENTYL]-6H-PURINE-6-ONE(ET1) (1)

    03 2-[(1S,2S)-1-ETHY1-2-BEZYLOXYPROPYL]-2,4-DIHYDRO-4-[4-[4-(4-HYDROXYPHENYL) -1-PIPERAZINYL]PHENYL]- 3H-1,2,4-TRIAZOL-3-ONE (POSACONAZOLE INTERMEDIATE POB) (1)

    04 ANIDULAFUNGIN (NON-STERILE API) (1)

    05 ANSAMITOCIN P-3 (1)

    06 ARGATROBAN (1)

    07 CARBOPROST TROMETHAMINE (1)

    08 CASPOFUNGIN ACETATE (DKB) (1)

    09 DALBAVANCIN HYDROCHLORIDE (1)

    10 DALBAVANCIN HYDROCHLORIDE (DB) (1)

    11 DALBAVANCIN PRECURSOR A40926 (1)

    12 DALBAVANCIN PRECURSOR A40926 (CBR48) (1)

    13 ENTECAVIR MONOHYDRATE (1)

    14 ERIBULIN MESYLATE (1)

    15 EVEROLIMUS (0.2%BHT) (1)

    16 EVEROLIMUS (NON-STERILE API) (1)

    17 EXATECAN MESYLATE (1)

    18 FERRIC CARBOXYMALTOSE (1)

    19 FIDAXOMICIN (1)

    20 FIDAXOMICIN CRYSTALLINE (1)

    21 FONDAPARINUX INTERMEDIATE FSC (1)

    22 FONDAPARINUX SODIUM (NON-STERILE, API) (1)

    23 FONDAPARINUX SODIUM USP (1)

    24 ISAVUCONAZONIUM SULFATE (1)

    25 LURBINECTEDIN (1)

    26 MERTANSINE (MTB) (1)

    27 MERTANSINE (MTS) (1)

    28 MICAFUNGIN SODIUM (NON-STERILE, API) (1)

    29 MICAFUNGIN SODIUM INTERMEDIATE A (1)

    30 MICAFUNGIN SODIUM INTERMEDIATE MCB (1)

    31 MIDOSTAURIN (1)

    32 MOLNUPIRAVIR (1)

    33 OBETICHOLIC ACID (1)

    34 OSELTAMIVIR PHOSPHATE (1)

    35 PEMETREXED ACID PMC (1)

    36 PIMECROLIMUS (NON-STERILE, API) (1)

    37 PIMECROLIMUS INTERMEDIATE ASCOMYCIN (1)

    38 PNEUMOCANDIN B0 (1)

    39 POSACONAZOLE (NON STERILE API) (1)

    40 POSACONAZOLE CRYSTALLINE I (NON-STERILE, API) (1)

    41 POSACONAZOLE CRYSTALLINE III (1)

    42 POSACONAZOLE FORM I (1)

    43 SIROLIMUS (1)

    44 SPINOSAD (1)

    45 STAUROSPORINE (1)

    46 SUGAMMADEX SODIUM (NON-STERILE, API) (1)

    47 TRABECTEDIN (1)

    48 TRIENTINE HYDROCHLORIDE USP (1)

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    01 BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD (47)

    02 BRIGHTGENE FERMENTATION TECHNOLOGY CO LTD (1)

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    ((3S,5R)-5-((1H-1,2,4-TRIAZOL-1-YL)...

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    2018-10-16
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    2-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4...

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    2012-08-12
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    2-[(1S,2S)-1-ETHY1-2-BEZYLOXYPROPYL...

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    2018-10-09
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    ANIDULAFUNGIN (NON-STERILE API)

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    2017-08-28
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    ANSAMITOCIN P-3

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    BRIGHTGENE FERMENTATI...
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    2019-12-23
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    ARGATROBAN

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    2021-10-01
    2021-04-14
    2020-12-26
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    CARBOPROST TROMETHAMINE

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    2022-08-31
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    CASPOFUNGIN ACETATE (DKB)

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    2019-09-12
    2019-09-29
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    DALBAVANCIN HYDROCHLORIDE

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    DALBAVANCIN HYDROCHLORIDE (DB)

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