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

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    01 Alprostadil (1)

    02 Beraprost Sodium (1)

    03 Betamethasone Acetate (1)

    04 Betamethasone Butyrate Propionate (1)

    05 Betamethasone Dipropionate (1)

    06 Betamethasone Sodium Phosphate (1)

    07 Betamethasone Valerate (1)

    08 Bimatoprost (1)

    09 Budesonide (2)

    10 Ciclesonide (1)

    11 Clobetasol Propionate (1)

    12 Clobetasone Butyrate (1)

    13 Cyproterone Acetate (1)

    14 Deflazacort (1)

    15 Desogestrel (1)

    16 Desonide (1)

    17 Dexamethasone (2)

    18 Dexamethasone Acetate (1)

    19 Dexamethasone Sodium Phosphate (1)

    20 Dienogest (1)

    21 Drospirenone (2)

    22 Flumethasone Pivalate (1)

    23 Fluocinolone Acetonide (1)

    24 Fluocinonide (1)

    25 Fluorometholone (1)

    26 Fluticasone Furoate (1)

    27 Fluticasone Propionate (1)

    28 Gestodene (1)

    29 Hydrocortisone (1)

    30 Hydrocortisone Acetate (1)

    31 Hydrocortisone Butyrate (1)

    32 Hydrocortisone Sodium Succinate (1)

    33 Iloprost (1)

    34 Latanoprost (1)

    35 Loteprednol Etabonate (1)

    36 Meprednisone (2)

    37 Methylprednisolone Acetate (1)

    38 Methylprednisolone Hemisuccinate (1)

    39 Methylprednisolone Sodium Succinate (1)

    40 Mometasone Furoate (3)

    41 Nomegestrol Acetate (1)

    42 Prednicarbate (1)

    43 Prednisolone (1)

    44 Prednisolone Sodium Phosphate (1)

    45 Prednisolone Valerate Acetate (1)

    46 Tibolone (1)

    47 Travoprost (1)

    48 Triamcinolone (1)

    49 Triamcinolone Acetonide (1)

    50 Ulipristal Acetate (1)

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    01 Active (9)

    02 Inactive (5)

    03 Blank (42)

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    01 Expired (1)

    02 Valid (18)

    03 Blank (37)

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    01 217MF10601 (1)

    02 217MF11152 (1)

    03 218MF10277 (1)

    04 219MF10361 (1)

    05 223MF10022 (1)

    06 228MF10196 (1)

    07 229MF10222 (1)

    08 303MF10110 (1)

    09 304MF10120 (1)

    10 Blank (47)

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    01 Blank (56)

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    Budesonide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25319
    Active
    BUDESONIDE MICRONIZED
    2011-08-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-185 - Rev 03
    Valid
    Budesonide, Micronised, non-microni...
    2023-07-20
    Japanese DMF

    Found JDMF

    228MF10196
    Budesonide at Via de Amicis 47, 201...
    2016-10-17
    Written Confirmation

    Close WC

    Application Number
    25319
    R1-CEP 2009-185 - Rev 03
    228MF10196
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    BUDESONIDE MICRONIZED
    Budesonide, Micronised, non-microni...
    Budesonide at Via de Amicis 47, 201...
    Issue/Submission Date
    2011-08-22
    2023-07-20
    2016-10-17
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    Drospirenone

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    USDMF

    Found USDMF

    22802
    Active
    DROSPIRENONE
    2009-05-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-370 - Rev 01
    Valid
    Drospirenone, Micronised, non-micro...
    2023-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22802
    R0-CEP 2021-370 - Rev 01
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    DROSPIRENONE
    Drospirenone, Micronised, non-micro...
    Issue/Submission Date
    2009-05-15
    2023-07-21
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    Drospirenone

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    USDMF

    Found USDMF

    36709
    Active
    DROSPIRENONE EP/USP
    2022-01-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-247 - Rev 01
    Valid
    Drospirenone, Micronised, non-micro...
    2023-08-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36709
    R1-CEP 2015-247 - Rev 01
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    DROSPIRENONE EP/USP
    Drospirenone, Micronised, non-micro...
    Issue/Submission Date
    2022-01-26
    2023-08-01
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    Fluticasone Propionate

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    USDMF

    Found USDMF

    22236
    Active
    FLUTICASONE PROPIONATE MICRONIZED
    2008-11-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-093 - Rev 05
    Valid
    Fluticasone propionate, Micronised,...
    2023-07-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22236
    R1-CEP 2006-093 - Rev 05
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    FLUTICASONE PROPIONATE MICRONIZED
    Fluticasone propionate, Micronised,...
    Issue/Submission Date
    2008-11-21
    2023-07-19
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    Latanoprost

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-368 - Rev 02
    Valid
    Latanoprost
    2023-07-21
    Japanese DMF

    Found JDMF

    229MF10222
    Latanoprost at Via de Amicis 47, 20...
    2017-12-25
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-368 - Rev 02
    229MF10222
    Status
    Valid
     
    Filing Details
    Latanoprost
    Latanoprost at Via de Amicis 47, 20...
    Issue/Submission Date
    2023-07-21
    2017-12-25
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    Methylprednisolone Hemisuccinate

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    USDMF

    Found USDMF

    22575
    Active
    METHYLPREDNISOLONE HEMISUCCINATE
    2009-02-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-185 - Rev 07
    Valid
    Methylprednisolone hydrogen succina...
    2023-07-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22575
    R1-CEP 2005-185 - Rev 07
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    METHYLPREDNISOLONE HEMISUCCINATE
    Methylprednisolone hydrogen succina...
    Issue/Submission Date
    2009-02-26
    2023-07-19
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    Mometasone Furoate

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    USDMF

    Found USDMF

    21993
    Active
    MOMETASONE FUROATE MICRONIZED
    2008-09-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-225 - Rev 03
    Valid
    Mometasone furoate, Micronised, non...
    2023-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21993
    R1-CEP 2007-225 - Rev 03
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    MOMETASONE FUROATE MICRONIZED
    Mometasone furoate, Micronised, non...
    Issue/Submission Date
    2008-09-15
    2023-07-20
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    Triamcinolone Acetonide

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    USDMF

    Found USDMF

    24543
    Active
    TRIAMCINOLONE ACETONIDE MICRONIZED
    2011-01-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-251 - Rev 05
    Valid
    Triamcinolone acetonide, Micronised
    2023-07-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24543
    R1-CEP 2005-251 - Rev 05
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    TRIAMCINOLONE ACETONIDE MICRONIZED
    Triamcinolone acetonide, Micronised
    Issue/Submission Date
    2011-01-07
    2023-07-19
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    Clobetasol Propionate

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    USDMF

    Caution USDMF

    22226
    Inactive
    CLOBETASOL 17-PROPIONATE
    2008-11-20
    CEP/COS

    Found CEP/COS

    CEP 2017-294 - Rev 03
    Valid
    Clobetasol propionate, Micronised
    2023-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22226
    CEP 2017-294 - Rev 03
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CLOBETASOL 17-PROPIONATE
    Clobetasol propionate, Micronised
    Issue/Submission Date
    2008-11-20
    2023-12-19
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    Nomegestrol Acetate

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    USDMF

    Caution USDMF

    22750
    Inactive
    NOMEGESTROL ACETATE
    2009-04-18
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-084 - Rev 01
    Valid
    Nomegestrol acetate
    2023-07-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22750
    R0-CEP 2020-084 - Rev 01
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    NOMEGESTROL ACETATE
    Nomegestrol acetate
    Issue/Submission Date
    2009-04-18
    2023-07-24
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