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

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    01 7-KETOLITHOCHOLIC ACID (1)

    02 AMINOCAPROIC ACID (1)

    03 AMITRIPTYLINE HYDROCHLORIDE (1)

    04 BUPROPION HCL (1)

    05 CARGLUMIC ACID (1)

    06 CHENODEOXYCHOLIC ACID (1)

    07 CILOSTAZOL (1)

    08 CYCLOBENZAPRINE HCL (1)

    09 CYPROHEPTADINE HCL, USP (1)

    10 DAPSONE (1)

    11 DEXLANSOPRAZOLE AMORPHOUS (1)

    12 DEXLANSOPRAZOLE ANHYDROUS (1)

    13 DICLOFENAC POTASSIUM (1)

    14 DICLOFENAC SODIUM EP/USP (1)

    15 DOXEPIN HCl (1)

    16 EFINACONAZOLE (1)

    17 ENTACAPONE (1)

    18 FESOTERODINE FUMARATE (1)

    19 FEXOFENADINE HYDROCHLORIDE USP (1)

    20 FEXOFENADINE HYDROCHLORIDE USP FORM A (1)

    21 FEXOFENADINE HYDROCHLORIDE USP FORM l (1)

    22 GILBENCLAMIDE/GLYBURIDE (1)

    23 GLYCERIN TRINITRATE (NITROGLYCERIN-NG) (1)

    24 GLYCERYL TRINITRATE SOLUTION (1)

    25 IBUPROFEN LYSINE SALT (1)

    26 ISOSORBIDE DINITRATE (ISDN) (1)

    27 ISOSORBIDE-5-MONONITRATE (5-ISMN) (1)

    28 MIGLUSTAT (1)

    29 MODAFINIL USP (1)

    30 NIFEDIPINE USP (1)

    31 NITISINONE (1)

    32 NORTRIPTYLINE HCL (1)

    33 PIRFENIDONE (1)

    34 PIROXICAM (1)

    35 PROTRIPTYLINE HYDROCHLORIDE (1)

    36 RUFINAMIDE USP (1)

    37 SAPROPTERIN DIHYDROCHLORIDE (1)

    38 SAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS) (1)

    39 SELEGILINE BASE (1)

    40 SELEGILINE HYDROCHLORIDE (1)

    41 TRAMADOL HCL (1)

    42 TRIAMTERENE USP (1)

    43 URSODEOXYCHOLIC ACID (1)

    44 VORTIOXETINE HYDROBROMIDE MONOHYDRATE (1)

    45 ZONISAMIDE (1)

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    01 DIPHARMA FRANCIS SRL (40)

    02 DIPHARMA SA (5)

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    01 Italy (42)

    02 Switzerland (3)

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    01 Active (45)

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    01 Complete (34)

    02 Blank (11)

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    7-KETOLITHOCHOLIC ACID

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    DIPHARMA FRANCIS SRL
    Active
    32475
    N/A
    2018-02-27
    II
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    AMINOCAPROIC ACID

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    DIPHARMA FRANCIS SRL
    Active
    31132
    Complete
    2017-09-21
    2017-07-25
    2016-12-14
    II
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    AMITRIPTYLINE HYDROCHLORIDE

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    DIPHARMA FRANCIS SRL
    Active
    2908
    N/A
    1977-03-18
    II
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    BUPROPION HCL

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    DIPHARMA FRANCIS SRL
    Active
    14534
    Complete
    2015-03-09
    2015-03-04
    1999-11-11
    II
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      CARGLUMIC ACID

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      DIPHARMA SA
      Active
      39329
      Complete
      2024-05-06
      2024-02-01
      2024-02-06
      II
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      CHENODEOXYCHOLIC ACID

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      DIPHARMA FRANCIS SRL
      Active
      34160
      Complete
      2020-11-10
      2020-10-29
      2019-09-30
      II
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      CILOSTAZOL

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      DIPHARMA FRANCIS SRL
      Active
      17050
      Complete
      2019-02-27
      2019-02-25
      2003-12-22
      II
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      CYCLOBENZAPRINE HCL

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      DIPHARMA FRANCIS SRL
      Active
      5864
      Complete
      2015-06-23
      2015-06-17
      1985-06-06
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      CYPROHEPTADINE HCL, USP

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      DIPHARMA FRANCIS SRL
      Active
      3524
      Complete
      2013-04-23
      2013-04-09
      1979-02-08
      II
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      DAPSONE

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      DIPHARMA FRANCIS SRL
      Active
      31521
      Complete
      2020-02-04
      2019-10-30
      2017-06-22
      II
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