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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by NEWCHEM SPA

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    NEWCHEM SPA
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    Italy
    Address
    Address
    Via E. De Amicis, 47 20123 Milano
    Telephone
    Telephone
    +39 02 58.15.16
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    enquiries@pharmacompass.com
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    • FDA
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    Budesonide

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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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    • FDA
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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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    • FDA
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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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    • FDA
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    Latanoprost

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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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    Beraprost Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10120
    Beraprost Sodium at Via San Vittore...
    2022-08-17
    Written Confirmation

    Close WC

    Application Number
    304MF10120
    Status
     
    Filing Details
    Beraprost Sodium at Via San Vittore...
    Issue/Submission Date
    2022-08-17
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    • FDA
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    Betamethasone Dipropionate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10277
    Betamethasone Butyrate Propionate a...
    2006-02-28
    Written Confirmation

    Close WC

    Application Number
    218MF10277
    Status
     
    Filing Details
    Betamethasone Butyrate Propionate a...
    Issue/Submission Date
    2006-02-28
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    • FDA
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    Betamethasone Sodium Phosphate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10601
    Betamethasone sodium phosphate at V...
    2005-09-14
    Written Confirmation

    Close WC

    Application Number
    217MF10601
    Status
     
    Filing Details
    Betamethasone sodium phosphate at V...
    Issue/Submission Date
    2005-09-14
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    • FDA
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    Ciclesonide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-060 - Rev 02
    Valid
    Ciclesonide, Micronised
    2023-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-060 - Rev 02
    Status
    Valid
     
    Filing Details
    Ciclesonide, Micronised
    Issue/Submission Date
    2023-07-21
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    • FDA
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    Clobetasone Butyrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10361
    Clobetasone butyric acid ester at V...
    2007-12-13
    Written Confirmation

    Close WC

    Application Number
    219MF10361
    Status
     
    Filing Details
    Clobetasone butyric acid ester at V...
    Issue/Submission Date
    2007-12-13
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    • FDA
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    Cyproterone Acetate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-365 - Rev 02
    Valid
    Cyproterone acetate, Micronised
    2023-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-365 - Rev 02
    Status
    Valid
     
    Filing Details
    Cyproterone acetate, Micronised
    Issue/Submission Date
    2023-07-20
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    • FDA
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    Deflazacort

    PDF Supplier PDF
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    USDMF

    Found USDMF

    38357
    Active
    DEFLAZACORT
    2023-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38357
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DEFLAZACORT
    Issue/Submission Date
    2023-05-19
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    • FDA
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    Dienogest

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2016-155 - Rev 01
    Valid
    Dienogest, Micronised, non-micronis...
    2023-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2016-155 - Rev 01
    Status
    Valid
     
    Filing Details
    Dienogest, Micronised, non-micronis...
    Issue/Submission Date
    2023-10-13
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    • FDA
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    Fluorometholone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10110
    Fluorometholone at Via de Amicis 47...
    2021-07-16
    Written Confirmation

    Close WC

    Application Number
    303MF10110
    Status
     
    Filing Details
    Fluorometholone at Via de Amicis 47...
    Issue/Submission Date
    2021-07-16
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    • FDA
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    Gestodene

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-174 - Rev 02
    Valid
    Gestodene, Micronised
    2023-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-174 - Rev 02
    Status
    Valid
     
    Filing Details
    Gestodene, Micronised
    Issue/Submission Date
    2023-07-20
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    • FDA
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    Hydrocortisone Acetate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2022-101 - Rev 00
    Valid
    Hydrocortisone acetate, Micronised
    2023-11-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2022-101 - Rev 00
    Status
    Valid
     
    Filing Details
    Hydrocortisone acetate, Micronised
    Issue/Submission Date
    2023-11-29
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    Hydrocortisone Butyrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10022
    Hydrocortisone butyrate at Via de A...
    2011-02-08
    Written Confirmation

    Close WC

    Application Number
    223MF10022
    Status
     
    Filing Details
    Hydrocortisone butyrate at Via de A...
    Issue/Submission Date
    2011-02-08
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    Mometasone Furoate

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-103 - Rev 01
    Valid
    Mometasone furoate monohydrate
    2023-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-103 - Rev 01
    Status
    Valid
     
    Filing Details
    Mometasone furoate monohydrate
    Issue/Submission Date
    2023-07-21
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    • FDA
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    Prednicarbate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-364 - Rev 01
    Valid
    Prednicarbate, Micronised
    2023-07-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-364 - Rev 01
    Status
    Valid
     
    Filing Details
    Prednicarbate, Micronised
    Issue/Submission Date
    2023-07-19
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    • FDA
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    Prednisolone Valerate Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11152
    Prednisolone Valerate Acetate at Vi...
    2005-12-12
    Written Confirmation

    Close WC

    Application Number
    217MF11152
    Status
     
    Filing Details
    Prednisolone Valerate Acetate at Vi...
    Issue/Submission Date
    2005-12-12
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    • FDA
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    Tibolone

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-329 - Rev 02
    Valid
    Tibolone
    2023-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-329 - Rev 02
    Status
    Valid
     
    Filing Details
    Tibolone
    Issue/Submission Date
    2023-07-20
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    • FDA
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    Ulipristal Acetate

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    USDMF

    Found USDMF

    32234
    Active
    ULIPRISTAL ACETATE
    2017-11-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32234
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    ULIPRISTAL ACETATE
    Issue/Submission Date
    2017-11-17
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