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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Fresenius Kabi Oncology Limited by EDQM. Original Data: EDQM Database

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    Fresenius Kabi Oncology Limited

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    APIs // Active Pharmaceutical Ingredients

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    01 Bicalutamide (1)

    02 Buflomedil Hydrochloride (1)

    03 Busulfan (1)

    04 Carboplatin (1)

    05 Cisplatin (1)

    06 Docetaxel (1)

    07 Docetaxel trihydrate (1)

    08 Gemcitabine hydrochloride (1)

    09 Gemcitabine hydrochloride, Alternate Process-2 (1)

    10 Gemcitabine hydrochloride, Alternate process (1)

    11 Irinotecan hydrochloride trihydrate (1)

    12 Letrozole (1)

    13 Oxaliplatin (1)

    14 Paclitaxel, Semi-synthetic process (1)

    15 Ropivacaine hydrochloride monohydrate (1)

    16 Ropivacaine hydrochloride monohydrate, Alternate process (1)

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    01 FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN (16)

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    01 India (16)

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    01 Valid (13)

    02 Withdrawn by Holder (3)

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    Bicalutamide

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    FRESENIUS KABI ONCOLOGY...
    Valid
    R1-CEP 2012-369 - Rev 00
    Chemical
    2021-05-20
    2196
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    Buflomedil Hydrochloride

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    FRESENIUS KABI ONCOLOGY...
    Withdrawn by Holder
    R0-CEP 2010-346 - Rev 00
    Chemical
    2013-04-04
    2015-11-24
    1398
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    Busulfan

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    FRESENIUS KABI ONCOLOGY...
    Valid
    CEP 2010-374 - Rev 07
    Chemical
    2023-10-13
    542
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    Carboplatin

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    FRESENIUS KABI ONCOLOGY...
    Valid
    R1-CEP 2001-282 - Rev 13
    Chemical
    2022-03-07
    1081
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    Cisplatin

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    FRESENIUS KABI ONCOLOGY...
    Withdrawn by Holder
    R1-CEP 2001-281 - Rev 01
    Chemical
    2009-05-15
    2016-08-10
    599
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    Docetaxel

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    FRESENIUS KABI ONCOLOGY...
    Valid
    CEP 2012-293 - Rev 02
    Chemical
    2023-11-17
    2593
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    Docetaxel trihydrate

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    FRESENIUS KABI ONCOLOGY...
    Valid
    R1-CEP 2011-189 - Rev 04
    Chemical
    2023-02-16
    2449
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    Gemcitabine hydrochloride

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    FRESENIUS KABI ONCOLOGY...
    Valid
    R1-CEP 2008-131 - Rev 04
    Chemical
    2022-02-11
    2306
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    Gemcitabine hydrochloride, Alternate process

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    FRESENIUS KABI ONCOLOGY...
    Valid
    R1-CEP 2012-080 - Rev 01
    Chemical
    2019-10-08
    2306
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    Gemcitabine hydrochloride, Alternate Process-2

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    FRESENIUS KABI ONCOLOGY...
    Valid
    CEP 2023-271 - Rev 00
    Chemical
    2023-12-06
    2306
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