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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Chemi Spa

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    01 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride (1)

    02 Alendronate Sodium (2)

    03 Benserazide Hydrochloride (1)

    04 Bupropion Hydrobromide (1)

    05 Bupropion Hydrochloride (2)

    06 Diarachidonyl Phosphatidylcholine (1)

    07 Diflunisal (1)

    08 Dimyristoyl Lecithin (2)

    09 Dimyristoylphosphatidylglycerol (1)

    10 Eptifibatide (1)

    11 Etodolac (1)

    12 Fesoterodine (1)

    13 Flunarizine (1)

    14 Givinostat (1)

    15 Goserelin Acetate (1)

    16 Hydroxyzine Dihydrochloride (1)

    17 Hydroxyzine Pamoate (1)

    18 Ibandronate Sodium (1)

    19 Indomethacin (1)

    20 Iopamidol (1)

    21 Leuprolide Acetate (1)

    22 Mesalazine (3)

    23 Miconazole (1)

    24 Miconazole Nitrate (1)

    25 Nabumetone (1)

    26 Octreotide Acetate (1)

    27 Oxiracetam (1)

    28 POPC (1)

    29 POPG (2)

    30 Paroxetine Hydrochloride (1)

    31 Ypo0Ntk49O (1)

    32 Zoledronic Acid (1)

    33 Blank (5)

    filter

    01 Active (11)

    02 Inactive (29)

    03 Blank (3)

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    01 Valid (7)

    02 Blank (36)

    filter

    01 219MF10131 (1)

    02 224MF10109 (1)

    03 224MF10177 (1)

    04 225MF10022 (1)

    05 226MF10055 (1)

    06 Blank (38)

    filter

    01 Blank (43)

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    • FDA
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    Leuprolide Acetate

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    USDMF

    Found USDMF

    14763
    Active
    LEUPROLIDE ACETATE
    2000-03-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-115 - Rev 04
    Valid
    Leuprorelin
    2022-03-10
    Japanese DMF

    Found JDMF

    224MF10177
    Leuprorelin acetate at Via dei Labo...
    2012-08-17
    Written Confirmation

    Close WC

    Application Number
    14763
    R1-CEP 2008-115 - Rev 04
    224MF10177
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEUPROLIDE ACETATE
    Leuprorelin
    Leuprorelin acetate at Via dei Labo...
    Issue/Submission Date
    2000-03-07
    2022-03-10
    2012-08-17
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    Mesalazine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    9454
    Inactive
    TERMINAL STERILZATION PROGRAM IN ME...
    1991-12-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-046 - Rev 03
    Valid
    Mesalazine, Product codes: FV0945, ...
    2020-03-17
    Japanese DMF

    Found JDMF

    219MF10131
    Mesalazine at Via dei Laboratori 54...
    2007-04-18
    Written Confirmation

    Close WC

    Application Number
    9454
    R1-CEP 2008-046 - Rev 03
    219MF10131
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TERMINAL STERILZATION PROGRAM IN ME...
    Mesalazine, Product codes: FV0945, ...
    Mesalazine at Via dei Laboratori 54...
    Issue/Submission Date
    1991-12-09
    2020-03-17
    2007-04-18
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    Nabumetone

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    USDMF

    Caution USDMF

    12296
    Inactive
    NABUMETONE
    1996-12-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-002 - Rev 01
    Valid
    Nabumetone, FV 4074
    2014-03-10
    Japanese DMF

    Found JDMF

    224MF10109
    Nabumetone at Viale dei Laboratori ...
    2012-06-22
    Written Confirmation

    Close WC

    Application Number
    12296
    R1-CEP 2007-002 - Rev 01
    224MF10109
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    NABUMETONE
    Nabumetone, FV 4074
    Nabumetone at Viale dei Laboratori ...
    Issue/Submission Date
    1996-12-23
    2014-03-10
    2012-06-22
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    Mesalazine

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    USDMF

    Found USDMF

    11951
    Active
    MESALAMINE USP
    1996-04-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-188 - Rev 06
    Valid
    Mesalazine, Products codes: FV 0950...
    2020-03-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11951
    R1-CEP 2003-188 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE USP
    Mesalazine, Products codes: FV 0950...
    Issue/Submission Date
    1996-04-29
    2020-03-31
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    Octreotide Acetate

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    USDMF

    Found USDMF

    19567
    Active
    OCTREOTIDE ACETATE
    2006-06-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10055
    Octreotide acetate "CHEMI" at Viale...
    2014-03-06
    Written Confirmation

    Close WC

    Application Number
    19567
    226MF10055
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OCTREOTIDE ACETATE
    Octreotide acetate "CHEMI" at Viale...
    Issue/Submission Date
    2006-06-28
    2014-03-06
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    Goserelin Acetate

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    USDMF

    Caution USDMF

    17768
    Inactive
    GOSERELIN ACETATE
    2004-10-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-276 - Rev 02
    Valid
    Goserelin
    2017-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17768
    R1-CEP 2005-276 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GOSERELIN ACETATE
    Goserelin
    Issue/Submission Date
    2004-10-18
    2017-01-31
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    Zoledronic Acid

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    USDMF

    Caution USDMF

    25983
    Inactive
    ZOLEDRONIC ACID HEMIPENTAHYDRATE
    2012-04-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10022
    Zoledronic acid "CHEMI" at Viale de...
    2013-02-06
    Written Confirmation

    Close WC

    Application Number
    25983
    225MF10022
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ZOLEDRONIC ACID HEMIPENTAHYDRATE
    Zoledronic acid "CHEMI" at Viale de...
    Issue/Submission Date
    2012-04-19
    2013-02-06
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    1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride

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    USDMF

    Found USDMF

    14013
    Active
    AICA HYDROCHLORIDE
    1999-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    14013
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AICA HYDROCHLORIDE
    Issue/Submission Date
    1999-03-05
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    Bupropion Hydrobromide

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    USDMF

    Found USDMF

    18922
    Active
    CHE001-05 (BUPROPIONE HYDROBROMIDE)
    2005-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18922
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHE001-05 (BUPROPIONE HYDROBROMIDE)
    Issue/Submission Date
    2005-10-27
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    Bupropion Hydrochloride

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    USDMF

    Found USDMF

    11834
    Active
    BUPROPION HYDROCHLORIDE
    1996-01-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11834
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BUPROPION HYDROCHLORIDE
    Issue/Submission Date
    1996-01-29
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