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

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    Heraeus Holding
    Germany Flag
    Country
    Country
    Germany
    Address
    Address
    Heraeus Deutschland GmbH & Co. KG, Heraeusstrasse 12-14, 63450 Hanau
    Telephone
    Telephone
    +49 61 81 355 443
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.heraeus-pharma.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/heraeus/
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    Twitter
    https://twitter.com/Heraeus

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    Carboplatin

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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

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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

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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

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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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    Epirubicin Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-086 - Rev 03
    Expired
    Epirubicin hydrochloride, Crystalli...
    2015-06-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2012-086 - Rev 03
    Status
    Expired
     
    Filing Details
    Epirubicin hydrochloride, Crystalli...
    Issue/Submission Date
    2015-06-12
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