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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zach System Sa

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    01 4-Methoxy-2 3 6-Trimethylbenzaldehyde (1)

    02 Abiraterone Acetate (1)

    03 Acetylcysteine (1)

    04 Acitretin (1)

    05 Bosentan Hydrate (1)

    06 Fosfomycin (1)

    07 Loteprednol Etabonate (1)

    08 Pioglitazone Hydrochloride (1)

    09 Safinamide Mesylate (1)

    10 Trimebutine Maleate (1)

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    01 Active (5)

    02 Blank (5)

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    01 Valid (3)

    02 Blank (7)

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    01 218MF10499 (1)

    02 304MF10141 (1)

    03 Blank (8)

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    01 Blank (10)

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    4-Methoxy-2 3 6-Trimethylbenzaldehyde

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    USDMF

    Found USDMF

    9158
    Active
    4-METHOXY-2,3,6-TRIMETHYLBENZALDEHY...
    1991-05-03
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    9158
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    4-METHOXY-2,3,6-TRIMETHYLBENZALDEHY...
    Issue/Submission Date
    1991-05-03
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    Abiraterone Acetate

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    NA Not Available For Sales
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    USDMF

    Found USDMF

    28412
    Active
    ABIRATERONE ACETATE
    2014-07-07
    CEP/COS

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    Japanese DMF

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    Application Number
    28412
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ABIRATERONE ACETATE
    Issue/Submission Date
    2014-07-07
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    Acetylcysteine

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    NA Not Available For Sales
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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2016-311 - Rev 00
    Valid
    Acetylcysteine
    2022-02-07
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2016-311 - Rev 00
    Status
    Valid
     
    Filing Details
    Acetylcysteine
    Issue/Submission Date
    2022-02-07
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    Acitretin

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    USDMF

    Found USDMF

    21113
    Active
    METHOXY-C15-WITTIG SALT (TGN05), IN...
    2007-12-03
    CEP/COS

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    Japanese DMF

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    Application Number
    21113
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METHOXY-C15-WITTIG SALT (TGN05), IN...
    Issue/Submission Date
    2007-12-03
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    Bosentan Hydrate

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    USDMF

    Found USDMF

    24929
    Active
    BOSENTAN MONOHYDRATE
    2011-05-09
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    24929
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BOSENTAN MONOHYDRATE
    Issue/Submission Date
    2011-05-09
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    Fosfomycin

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    NA Not Available For Sales
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-370 - Rev 02
    Valid
    Fosfomycin trometamol
    2023-07-03
    Japanese DMF

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    Written Confirmation

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    Application Number
    R0-CEP 2020-370 - Rev 02
    Status
    Valid
     
    Filing Details
    Fosfomycin trometamol
    Issue/Submission Date
    2023-07-03
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    Loteprednol Etabonate

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    USDMF

    Found USDMF

    11105
    Active
    LOTEPREDNOL ETABONATE
    1994-09-26
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    11105
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LOTEPREDNOL ETABONATE
    Issue/Submission Date
    1994-09-26
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    Pioglitazone Hydrochloride

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    NA Not Available For Sales
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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    218MF10499
    Pioglitazone hydrochloride at Z. I....
    2006-05-15
    Written Confirmation

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    Application Number
    218MF10499
    Status
     
    Filing Details
    Pioglitazone hydrochloride at Z. I....
    Issue/Submission Date
    2006-05-15
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    Safinamide Mesylate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10141
    Safinamide Mesylate at Z. I. La Cro...
    2022-10-12
    Written Confirmation

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    Application Number
    304MF10141
    Status
     
    Filing Details
    Safinamide Mesylate at Z. I. La Cro...
    Issue/Submission Date
    2022-10-12
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    Trimebutine Maleate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-207 - Rev 00
    Valid
    Trimebutine maleate
    2019-08-30
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2013-207 - Rev 00
    Status
    Valid
     
    Filing Details
    Trimebutine maleate
    Issue/Submission Date
    2019-08-30
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