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

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    • FDA
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    ADENOSINE

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    EUTICALS SPA
    Active
    22232
    Complete
    2013-09-21
    2013-09-17
    2008-11-25
    II
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    AMRINONE, USP

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    ARCHIMICA SPA
    Inactive
    13193
    N/A
    1998-09-22
    II
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    ATENOLOL

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    ARCHIMICA SPA
    Inactive
    8834
    N/A
    1990-10-10
    II
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    AZACITIDINE

    PDF Supplier PDF
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    EUTICALS SPA
    Inactive
    25265
    N/A
    2011-09-07
    II
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    BENDAMUSTINE HYDROCHLORIDE HYDRATE

    PDF Supplier PDF
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    EUTICALS SPA
    Inactive
    25394
    N/A
    2011-10-18
    II
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    BENZOCAINE USP-EP

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    ARCHIMICA SRL
    Inactive
    16638
    N/A
    2003-06-06
    II
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    BROENAC SODIUM

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    ARCHIMICA SPA
    Active
    23704
    Complete
    2013-07-31
    2013-07-18
    2010-04-12
    II
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    BULK CRUDE PROPOFOL

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    ARCHIMICA SPA
    Inactive
    11596
    N/A
    1995-07-25
    II
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    BUSPIRONE HYDROCHLORIDE

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    ARCHIMICA SPA
    Inactive
    10414
    N/A
    1993-08-09
    II
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    BUSULFAN

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    EUTICALS SPA
    Inactive
    25393
    N/A
    2011-10-18
    II
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    CAPECITABINE

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    ARCHIMICA SPA
    Active
    25266
    N/A
    2011-09-07
    II
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    CYTARABINE

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    ARCHIMICA SPA
    Active
    25267
    Complete
    2013-12-18
    2013-01-15
    2011-09-07
    II
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    DESIPRAMINE HYDROCHLORIDE USP

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    ARCHIMICA SPA
    Inactive
    7216
    N/A
    1987-10-28
    II
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    DIACEREIN (PROCESS I)

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    ARCHIMICA SPA
    Active
    23960
    N/A
    2010-07-13
    II
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    DIACEREIN (PROCESS II)

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    EUTICALS SPA
    Active
    23961
    N/A
    2010-07-13
    II
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    DISOPYRAMIDE PHOSPHATE

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    ARCHIMICA SPA
    Active
    14204
    N/A
    1999-06-11
    II
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    DOXYLAMINE SUCCINATE USP

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    ARCHIMICA SPA
    Inactive
    7215
    N/A
    1987-10-28
    II
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    • FDA
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    ERYTHROMYCIN ETHYLSUCCINATE

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    ARCHIFAR LAB
    Inactive
    13600
    N/A
    1998-09-01
    II
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    ERYTHROMYCIN STEARATE

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    ARCHIFAR LAB
    Inactive
    13478
    N/A
    1998-09-01
    II
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    ETHYL-4-N(n-BUTYLAMINO) BENZOATE

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    ARCHIMICA LTD
    Inactive
    8970
    N/A
    1991-02-21
    II
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    FLUDARABINE PHOSPHATE

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    EUTICALS SPA
    Inactive
    17374
    N/A
    2004-05-13
    II
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    GEMCITABINE HYDROCHLORIDE

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    EUTICALS SPA
    Inactive
    23516
    N/A
    2010-02-12
    II
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    HYDRALAZINE HYDROCHLORIDE

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    ARCHIMICA SPA
    Active
    22169
    Complete
    2015-02-27
    2014-04-25
    2008-10-31
    II
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    HYDRALAZINE HYDROCHLORIDE INJECTABL...

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    EUTICALS SPA
    Inactive
    22682
    N/A
    2009-03-20
    II
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    HYDROXYUREA

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    ARCHIMICA SPA
    Active
    12754
    Complete
    2019-02-13
    2019-02-08
    1997-11-14
    II
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    IMIPRAMINE HYDROCHLORIDE

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    ARCHIMICA SPA
    Inactive
    7190
    N/A
    1987-10-18
    II
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    LITHIUM CARBONATE PHARMA GRADE

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    EUTICALS SPA
    Active
    23175
    Complete
    2013-07-08
    2013-03-25
    2009-10-07
    II
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    NITRO-THIAZOLINEBULK

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    ARCHIMICA SPA
    Inactive
    10531
    N/A
    1993-10-19
    II
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    OXCARBAZEPINE

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    ARCHIMICA SPA
    Active
    16588
    Complete
    2013-02-26
    2013-02-06
    2003-05-15
    II
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    PIRENZEPINE BASE PURE

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    ARCHIMICA SPA
    Active
    33591
    N/A
    2019-06-06
    II
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    PIRENZEPINE DIHYDROCHLORIDE

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    ARCHIMICA SPA
    Active
    13831
    N/A
    1998-11-05
    II
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    RIBAVIRIN

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    EUTICALS SPA
    Inactive
    23004
    N/A
    2009-08-03
    II
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    SANCYCLINE

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    ARCHIMICA SPA
    Inactive
    11842
    N/A
    1996-01-26
    II
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    SUCRALFATE

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    ARCHIMICA SPA
    Active
    16589
    Complete
    2014-04-18
    2014-04-09
    2003-05-13
    II
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    SULFAPYRIDINE

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    ARCHIMICA SPA
    Active
    6658
    N/A
    1986-10-29
    II
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    TCC TRICLOCARBAN (3,4,4'-TRICHLORO...

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    ARCHIMICA LTD
    Inactive
    215
    N/A
    1965-05-21
    II
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    TERAZOSIN HYDROCHLORIDE

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    ARCHIMICA SRL
    Inactive
    19480
    N/A
    2006-05-25
    II
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    TETRACYCLINE

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    ARCHIFAR LAB
    Inactive
    13465
    N/A
    1998-09-01
    II
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    TETRACYCLINE HYDROCHLORIDE

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    ARCHIFAR LAB
    Inactive
    13456
    N/A
    1998-09-01
    II
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    • FDA
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    2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOE...

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    ARCHIMICA SPA
    Inactive
    8261
    N/A
    1989-10-12
    II
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    2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOE...

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    ARCHIMICA SPA
    Inactive
    8262
    N/A
    1989-10-12
    II
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    FACILITIES, PERSONNEL, AND GENERAL ...

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    PRIME EUROPEAN THERAP...
    Inactive
    6743
    N/A
    1986-12-19
    II
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    FACILITY IN ORIGGIO (VARESE), ITALY

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    ARCHIMICA SPA
    Inactive
    10048
    N/A
    1993-01-21
    II
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    OP 3300/15

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    ARCHIMICA SPA
    Inactive
    11760
    N/A
    1995-11-28
    II
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