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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Heraeus Holding

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    01 Aminolevulinic Acid HCl (1)

    02 Arsenic Trioxide (1)

    03 Bendamustine Hydrochloride (1)

    04 Carboplatin (1)

    05 Cisplatin (1)

    06 Dacarbazine (1)

    07 Epirubicin Hydrochloride (2)

    08 Oxaliplatin (2)

    09 Thiotepa (1)

    filter

    01 Active (9)

    02 Blank (2)

    filter

    01 Expired (1)

    02 Valid (5)

    03 Withdrawn by Holder (1)

    04 Blank (4)

    filter

    01 218MF10212 (1)

    02 218MF10722 (1)

    03 224MF10077 (1)

    04 224MF10095 (1)

    05 225MF10122 (1)

    06 229MF10141 (1)

    07 302MF10088 (1)

    08 Blank (4)

    filter

    01 Blank (11)

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    Carboplatin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15147
    Active
    CARBOPLATIN USP
    2000-11-17
    CEP/COS

    Found CEP/COS

    CEP 2002-091 - Rev 08
    Valid
    Carboplatin
    2023-10-02
    Japanese DMF

    Found JDMF

    218MF10722
    Carboplatin at Heraeusstr. 12-14;63...
    2006-09-06
    Written Confirmation

    Close WC

    Application Number
    15147
    CEP 2002-091 - Rev 08
    218MF10722
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CARBOPLATIN USP
    Carboplatin
    Carboplatin at Heraeusstr. 12-14;63...
    Issue/Submission Date
    2000-11-17
    2023-10-02
    2006-09-06
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    Cisplatin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    6662
    Active
    CISPLATIN USP
    1986-11-01
    CEP/COS

    Found CEP/COS

    CEP 2003-075 - Rev 04
    Valid
    Cisplatin
    2023-10-04
    Japanese DMF

    Found JDMF

    218MF10212
    Cisplatin at Heraeusstr. 12-14;6345...
    2006-03-20
    Written Confirmation

    Close WC

    Application Number
    6662
    CEP 2003-075 - Rev 04
    218MF10212
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CISPLATIN USP
    Cisplatin
    Cisplatin at Heraeusstr. 12-14;6345...
    Issue/Submission Date
    1986-11-01
    2023-10-04
    2006-03-20
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    Oxaliplatin

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    USDMF

    Found USDMF

    19633
    Active
    OXALIPLATIN
    2006-07-28
    CEP/COS

    Found CEP/COS

    CEP 2003-278 - Rev 08
    Valid
    Oxaliplatin, Process HER-1
    2023-10-02
    Japanese DMF

    Found JDMF

    225MF10122
    Oxaliplatin at Heraeusstr. 12-14;63...
    2013-06-18
    Written Confirmation

    Close WC

    Application Number
    19633
    CEP 2003-278 - Rev 08
    225MF10122
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXALIPLATIN
    Oxaliplatin, Process HER-1
    Oxaliplatin at Heraeusstr. 12-14;63...
    Issue/Submission Date
    2006-07-28
    2023-10-02
    2013-06-18
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    Aminolevulinic Acid HCl

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    USDMF

    Found USDMF

    24359
    Active
    5-AMINOLEVULINIC ACID HYDROCHLORIDE
    2010-11-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10095
    5-Aminolevulinic acid hydrochloride...
    2012-04-27
    Written Confirmation

    Close WC

    Application Number
    24359
    224MF10095
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    5-AMINOLEVULINIC ACID HYDROCHLORIDE
    5-Aminolevulinic acid hydrochloride...
    Issue/Submission Date
    2010-11-12
    2012-04-27
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    Arsenic Trioxide

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    USDMF

    Found USDMF

    20033
    Active
    ARSENIC TRIOXIDE USP
    2006-12-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10077
    Arsenic trioxide at Heraeusstr. 12-...
    2012-04-08
    Written Confirmation

    Close WC

    Application Number
    20033
    224MF10077
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ARSENIC TRIOXIDE USP
    Arsenic trioxide at Heraeusstr. 12-...
    Issue/Submission Date
    2006-12-13
    2012-04-08
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    Bendamustine Hydrochloride

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    USDMF

    Found USDMF

    25512
    Active
    BENDAMUSTINE HYDROCHLORIDE MONOHYDR...
    2011-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10088
    Bendamustine Hydrochloride Monohydr...
    2020-07-29
    Written Confirmation

    Close WC

    Application Number
    25512
    302MF10088
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BENDAMUSTINE HYDROCHLORIDE MONOHYDR...
    Bendamustine Hydrochloride Monohydr...
    Issue/Submission Date
    2011-11-18
    2020-07-29
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    Dacarbazine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12862
    Active
    DACARBAZINE, USP
    1998-02-13
    CEP/COS

    Found CEP/COS

    CEP 2008-036 - Rev 03
    Valid
    Dacarbazine
    2023-10-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12862
    CEP 2008-036 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DACARBAZINE, USP
    Dacarbazine
    Issue/Submission Date
    1998-02-13
    2023-10-02
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    Oxaliplatin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20054
    Active
    OXALIPLATIN PROCESS HER-2 USP
    2006-12-19
    CEP/COS

    Found CEP/COS

    CEP 2006-137 - Rev 05
    Valid
    Oxaliplatin, Process HER-2
    2023-10-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20054
    CEP 2006-137 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXALIPLATIN PROCESS HER-2 USP
    Oxaliplatin, Process HER-2
    Issue/Submission Date
    2006-12-19
    2023-10-02
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    Thiotepa

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    USDMF

    Found USDMF

    13911
    Active
    THIOTEPA USP
    1998-12-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10141
    Thiotepa at Heraeusstr. 12-14;63450...
    2017-07-25
    Written Confirmation

    Close WC

    Application Number
    13911
    229MF10141
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    THIOTEPA USP
    Thiotepa at Heraeusstr. 12-14;63450...
    Issue/Submission Date
    1998-12-24
    2017-07-25
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    Epirubicin Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-229 - Rev 02
    Withdrawn by Holder
    Epirubicin hydrochloride
    2012-04-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2010-229 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Epirubicin hydrochloride
    Issue/Submission Date
    2012-04-17
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