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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Lunan Pharmaceutical to the U.S. FDA. Original Data : FDA Website

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    01 ALFUZOSIN HYDROCHLORIDE (1)

    02 AMINODESACETOXYCEPHALOSPORANIC ACID (7-ADCA) (1)

    03 CARFILZOMIB (1)

    04 CLAVULANATE POTASSIUM (1)

    05 DAUNORUBICIN HYDROCHLORIDE (1)

    06 DILUTED ISOSORBIDE DINITRATE USP (1)

    07 DILUTED ISOSORBIDE MONONITRATE (60%) (1)

    08 DILUTED ISOSORBIDE MONONITRATE (70%) (1)

    09 DILUTED ISOSORBIDE MONONITRATE USP (1)

    10 ELAGOLIX SODIUM (1)

    11 EPIRUBICIN HYDROCHLORIDE (1)

    12 EPIRUBICIN HYDROCHLORIDE USP (1)

    13 ESOMEPRAZOLE SODIUM (1)

    14 GIMERACIL (1)

    15 ISOFLURANE (NON-STERILE BULK) (1)

    16 ISOFLURANE USP (1)

    17 ISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM) (1)

    18 KETOROLAC TROMETHAMINE (NON-STERILE, BULK FORM) (1)

    19 KETOROLAC TROMETHAMINE USP (1)

    20 MILRINONE, USP (1)

    21 MONTELUKAST SODIUM USP (1)

    22 MOSAPRIDE CITRATE (NON-STERILE BULK FORM) (1)

    23 MYCOPHENOLATE MOFETIL (1)

    24 MYCOPHENOLIC ACID (1)

    25 ORLISTAT (1)

    26 OTERACIL POTASSIUM (1)

    27 POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1 (1)

    28 POTASSIUM CLAVULANATE, DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1 (1)

    29 POTASSIUM CLAVULANATE, DILUTED, NON-STERILE BULK FORM (1)

    30 RAPAMYCIN (1)

    31 SEVOFLURANE (NON-STERILE BULK FORM) (1)

    32 SEVOFLURANE USP (1)

    33 SIROLIMUS INTERMEDIATE (1)

    34 SITAGLIPTIN PHOSPHATE USP (1)

    35 TACROLIMUS (1)

    36 TACROLIMUS USP (1)

    37 TADALAFIL (1)

    38 TEGAFUR (1)

    39 ZOLEDRONIC ACID (1)

    40 ZOLEDRONIC ACID MONOHYDRATE (1)

    41 ZOLPIDEM TARTRATE (NON-STERILE BULK FORM) (1)

    42 ZOLPIDEM TARTRATE USP (1)

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    04 SHANDONG NEW TIME PHARMACEUTICAL CO LTD (34)

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      ALFUZOSIN HYDROCHLORIDE

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      SHANDONG NEW TIME PHA...
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      20350
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      2007-03-13
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        AMINODESACETOXYCEPHALOSPORANIC ACID...

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        SHANDONG NEW TIME PHA...
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        21138
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        2007-12-12
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          CARFILZOMIB

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          SHANDONG NEW TIME PHA...
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          38290
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          2023-07-05
          2023-05-15
          2023-05-16
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            CLAVULANATE POTASSIUM

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            25718
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            2012-01-16
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              DAUNORUBICIN HYDROCHLORIDE

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              SHANDONG NEW TIME PHA...
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              38625
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              2023-08-17
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                DILUTED ISOSORBIDE DINITRATE USP

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                SHANDONG NEW TIME PHA...
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                36099
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                2024-03-12
                2024-01-31
                2021-12-05
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                  DILUTED ISOSORBIDE MONONITRATE (60%...

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                  SHANDONG NEW TIME PHA...
                  Active
                  23216
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                  2014-04-28
                  2013-12-24
                  2009-10-21
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                    DILUTED ISOSORBIDE MONONITRATE (70%...

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                    2009-10-21
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                      DILUTED ISOSORBIDE MONONITRATE USP

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                      SHANDONG NEW TIME PHA...
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                      29555
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                      2019-01-22
                      2018-11-26
                      2015-07-17
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                        ELAGOLIX SODIUM

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                        SHANDONG NEW TIME PHA...
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                        37696
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                        2024-01-09
                        2023-09-19
                        2022-12-25
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