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

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    01 6-ALPHA METHYLPREDNISOLONE (1)

    02 6-AMINOPENICILLANIC ACID (1)

    03 ACEBUTOLOL HYDROCHLORIDE (1)

    04 ACYCLOVIR (1)

    05 AMOXICILLIN TRIHYDRATE (1)

    06 APREMILAST (1)

    07 APREMILAST (PROCESS II) (1)

    08 ASTEMIZOLE (1)

    09 AZITHROMYCIN HYDROGENCITRATE (1)

    10 BECLOMETHASONE DIPROPIONATE USP (1)

    11 BENAZEPRIL HYDROCHLORIDE (1)

    12 BENZNIDAZOLE (1)

    13 BETAMETHASONE ACETATE (1)

    14 BETAMETHASONE BASE USP XX (1)

    15 BETAMETHASONE DIPROPIONATE (1)

    16 BETAMETHASONE SODIUM PHOSPHATE (1)

    17 BETAMETHASONE VALERATE USP XX (1)

    18 BUMETANIDE (1)

    19 BUSPIRONE (1)

    20 BUTOCONAZOLE NITRATE (1)

    21 CAPTOPRIL (1)

    22 CHLORAMPHENICOL (1)

    23 CHLORAMPHENICOL PALMITATE (1)

    24 CIMETIDINE USP XXII (1)

    25 CINOXACIN USP XXII (1)

    26 CIPROFLOXACIN (1)

    27 CIPROFLOXACIN HYDROCHLORIDE (2)

    28 DEXAMETHASONE BASE, USP XX (1)

    29 DROXIDOPA (1)

    30 EDARAVONE (1)

    31 ELTROMBOPAG OLAMINE (1)

    32 ETODOLAC (1)

    33 FACIL, PERSONNEL AND GENL OPERATING PROCEDURES AT MADRID,SPAIN (1)

    34 FAMOTIDINE (2)

    35 FLUCONAZOLE (1)

    36 FLUOXETINE HYDROCHLORIDE (1)

    37 FOSFOMYCIN TROMETHAMINE (1)

    38 FOSINOPRIL SODIUM (1)

    39 GUANFACINE HYDROCHLORIDE (1)

    40 HYDROCORTISONE HEMISUCCINATE (1)

    41 INDAPAMIDE (1)

    42 IRBESARTAN (1)

    43 ITRACONAZOLE (2)

    44 KETOCONAZOLE (3)

    45 KETOROLAC TROMETHAMINE (1)

    46 KETOTIFEN FUMERATE (1)

    47 LANZOPRAZOLE (1)

    48 LEVOFLOXACIN (2)

    49 LEVOMILNACIPRAN HYDROCHLORIDE (1)

    50 LOPERAMIDE HCL (1)

    51 LORATADINE (2)

    52 MECLOFENAMATE SODIUM USP (1)

    53 MEDROXY PROGESTERONE ACETATE (1)

    54 MEFENAMIC ACID (1)

    55 MELOXICAM (1)

    56 MICONAZOLE NITRATE (1)

    57 NORFLOXACIN USP XXII (1)

    58 OFLOXACIN (1)

    59 OMEPRAZOLE (1)

    60 PANTOPRAZOLE SODIUM (1)

    61 POSACONAZOLE (1)

    62 PREDNISOLONE SODIUM PHOSPHATE, USP XX (1)

    63 RANITIDINE HCL FORM 1 (1)

    64 RANITIDINE HYDROCHLORIDE (1)

    65 SUMATRIPTAN (1)

    66 SUMATRIPTAN SUCCINATE (1)

    67 TERBINAFINE HYDROCHLORIDE (1)

    68 TERCONAZOLE (1)

    69 TERFENADINE (1)

    70 TRIAMCINOLONE ACETONIDE USPXX (1)

    71 ZOLPIDEM TARTRATE (1)

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    01 COMPANIA ESPANOLA DE SINTESIS QUIMICA SA (12)

    02 QUIMICA FINA FARMEX SA DE CV (2)

    03 QUIMICA SINTETICA SA (62)

    04 SINTESIS QUIMICA (1)

    05 SINTESIS QUIMICA SA (1)

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    02 Inactive (47)

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    01 Complete (21)

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    6-ALPHA METHYLPREDNISOLONE

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    COMPANIA ESPANOLA DE ...
    Inactive
    6725
    N/A
    1986-12-15
    II
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    6-AMINOPENICILLANIC ACID

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    SINTESIS QUIMICA SA
    Inactive
    11167
    N/A
    1994-10-26
    II
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    ACEBUTOLOL HYDROCHLORIDE

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    QUIMICA SINTETICA SA
    Inactive
    8874
    N/A
    1990-12-04
    II
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    ACYCLOVIR

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    QUIMICA SINTETICA SA
    Active
    8584
    Complete
    2014-02-07
    2014-01-29
    1990-05-25
    II
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    AMOXICILLIN TRIHYDRATE

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    SINTESIS QUIMICA
    Inactive
    13215
    N/A
    1998-04-30
    II
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    APREMILAST

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    QUIMICA SINTETICA SA
    Active
    32119
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    2018-02-02
    2017-11-06
    2017-10-10
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    APREMILAST (PROCESS II)

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    QUIMICA SINTETICA SA
    Active
    34915
    Complete
    2020-09-04
    2020-07-14
    2020-06-17
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    ASTEMIZOLE

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    QUIMICA SINTETICA SA
    Inactive
    9443
    N/A
    1991-11-11
    II
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    AZITHROMYCIN HYDROGENCITRATE

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    QUIMICA SINTETICA SA
    Inactive
    17951
    N/A
    2004-12-29
    II
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    BECLOMETHASONE DIPROPIONATE USP

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    COMPANIA ESPANOLA DE ...
    Inactive
    6084
    N/A
    1985-11-04
    II
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