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

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    Chemi SpA
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    Via dei lavoratori 54, 20092 Cinisello Balsamo (Milano)
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    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...

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    CHEMI SPA
    Inactive
    14094
    N/A
    1999-04-23
    II
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    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...

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    CHEMI SPA
    Inactive
    14976
    N/A
    2000-07-28
    II
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    AICA HYDROCHLORIDE

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    CHEMI SPA
    Active
    14013
    N/A
    1999-03-05
    II
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    BUPROPION HCL FV3307

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    CHEMI SPA
    Active
    23208
    N/A
    2009-10-19
    II
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    BUPROPION HYDROCHLORIDE

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    CHEMI SPA
    Active
    11834
    N/A
    1996-01-29
    II
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    CHE001-05 (BUPROPIONE HYDROBROMIDE)

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    CHEMI SPA
    Active
    18922
    N/A
    2005-10-27
    II
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    DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3...

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    CHEMI SPA
    Inactive
    21381
    N/A
    2008-02-20
    II
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    DIFLUNISAL

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    CHEMI SPA
    Active
    7492
    N/A
    1988-05-22
    II
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    DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLI...

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    CHEMI SPA
    Inactive
    12998
    N/A
    1998-05-22
    II
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    DMPC STANDARD

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    CHEMI SPA
    Inactive
    13284
    N/A
    1998-10-20
    II
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    DMPG. NA (DIMYRISTOYL-PHOSPHATIDYLG...

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    CHEMI SPA
    Inactive
    13104
    N/A
    1998-07-31
    II
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    EPTIFIBATIDE

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    CHEMI SPA
    Inactive
    24933
    N/A
    2011-05-11
    II
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    ETODOLAC

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    CHEMI SPA
    Inactive
    11740
    N/A
    1995-11-06
    II
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    FESOTERODINE FUMARATE

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    CHEMI SPA
    Inactive
    26498
    N/A
    2012-09-28
    II
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    GIVINOSTAT HYDROCHLORIDE MONOHYDRAT...

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    CHEMI SPA
    Active
    37344
    N/A
    2023-04-04
    II
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    GOSERELIN ACETATE

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    CHEMI SPA
    Inactive
    17768
    N/A
    2004-10-18
    II
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    HYDROXYZINE HCL.USP. XX 093082

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    CHEMI SPA
    Inactive
    4622
    N/A
    1982-08-11
    II
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    HYDROXYZINE PAMOATE USP. XX

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    CHEMI SPA
    Inactive
    4629
    N/A
    1982-08-11
    II
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    INDOMETHACINE USP XX

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    CHEMI SPA
    Inactive
    4394
    N/A
    1982-01-18
    II
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    LEUPROLIDE ACETATE

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    CHEMI SPA
    Active
    14763
    Complete
    2014-10-20
    2013-01-11
    2000-03-07
    II
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    MESALAMINE CRYSTALLIZED, USP

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    CHEMI SPA
    Active
    25385
    Complete
    2013-12-12
    2013-04-11
    2011-10-13
    II
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    MESALAMINE USP

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    CHEMI SPA
    Active
    11951
    Complete
    2012-12-27
    2012-11-19
    1996-04-29
    II
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    MICONAZOLE BASE

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    CHEMI SPA
    Inactive
    9648
    N/A
    1992-04-16
    II
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    MICONAZOLE NITRATE

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    CHEMI SPA
    Inactive
    9540
    N/A
    1992-02-10
    II
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    NABUMETONE

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    CHEMI SPA
    Inactive
    12296
    N/A
    1996-12-23
    II
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    OCTREOTIDE ACETATE

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    CHEMI SPA
    Active
    19567
    N/A
    2006-06-28
    II
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    OXIRACETAM

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    CHEMI SPA
    Inactive
    8272
    N/A
    1989-10-24
    II
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    PAROXETINE ACETATE

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    CHEMI SPA
    Inactive
    15463
    N/A
    2001-05-29
    II
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    PENTAACETYLIOPAMIDOL INTERMEDIATE

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    CHEMI SPA
    Inactive
    12229
    N/A
    1996-11-13
    II
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    POPC POSITIONAL PURITY 95%

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    CHEMI SPA
    Inactive
    15498
    N/A
    2001-06-22
    II
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    SODIUM ALENDRONATE

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    CHEMI SPA
    Inactive
    15858
    N/A
    2002-02-12
    II
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    SODIUM ALENDRONATE TRIHYDRATE

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    CHEMI SPA
    Inactive
    19934
    N/A
    2006-11-03
    II
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    SODIUM IBANDRONATE MONOHYDRATE

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    CHEMI SPA
    Active
    20427
    N/A
    2007-04-05
    II
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    TERMINAL STERILZATION PROGRAM IN ME...

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    CHEMI SPA
    Inactive
    9454
    N/A
    1991-12-09
    II
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    ZOLEDRONIC ACID HEMIPENTAHYDRATE

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    CHEMI SPA
    Inactive
    25983
    N/A
    2012-04-19
    II
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    5-ASA CRYSTALLIZED

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    CHEMI SPA
    Inactive
    11952
    N/A
    1996-05-02
    II
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    DPPC (DIPALMITOYL-PHOSPHATATIDYLCHO...

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    CHEMI SPA
    Inactive
    12717
    N/A
    1997-10-21
    II
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    • FDA
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    DSPC(1,2-DISTEAROYL-PHOPHATIDYCHOLI...

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    CHEMI SPA
    Inactive
    13912
    N/A
    1998-12-23
    II
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    • FDA
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    MANUFACTURING SITE, FACILITIES, PER...

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    CHEMI SPA
    Inactive
    8203
    N/A
    1989-09-07
    II
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    • FDA
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    POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCER...

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    CHEMI SPA
    Inactive
    14527
    N/A
    1999-11-09
    II
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