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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Kyowa Hakko Bio Co Ltd by EDQM. Original Data: EDQM Database

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    01 Alanine (1)

    02 Arginine (1)

    03 Arginine hydrochloride (1)

    04 Aspartic Acid (1)

    05 Dexpanthenol (1)

    06 Dinoprostone (1)

    07 Glutathione (2)

    08 Histidine (1)

    09 Histidine Hydrochloride Monohydrate (1)

    10 Isoleucine (1)

    11 Latanoprost (1)

    12 Leucine (1)

    13 Lysine Hydrochloride (1)

    14 Lysine acetate (1)

    15 Phenylalanine (1)

    16 Pravastatin sodium (1)

    17 Proline (1)

    18 Serine (1)

    19 Threonine (1)

    20 Tranexamic acid (1)

    21 Tryptophan (1)

    22 Valine (1)

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    01 Daiichi Fine Chemical Co., Ltd. Takaoka JP (1)

    02 KYOWA HAKKO BIO CO., LTD. Tokyo JP (19)

    03 KYOWA PHARMA CHEMICAL CO., LTD. Takaoka JP (3)

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    01 Japan (23)

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    01 Expired (1)

    02 Valid (19)

    03 Withdrawn by Holder (3)

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    Alanine

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    KYOWA HAKKO BIO CO., LT...
    Valid
    R1-CEP 1999-013 - Rev 02
    Chemical
    2014-07-30
    752
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    Arginine

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    KYOWA HAKKO BIO CO., LT...
    Valid
    R1-CEP 1998-109 - Rev 05
    Chemical
    2022-03-18
    806
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    Arginine hydrochloride

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    KYOWA HAKKO BIO CO., LT...
    Valid
    R1-CEP 1999-028 - Rev 04
    Chemical
    2022-06-20
    805
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    Aspartic Acid

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    KYOWA HAKKO BIO CO., LT...
    Withdrawn by Holder
    R1-CEP 1999-190 - Rev 01
    Chemical
    2010-03-08
    2018-01-23
    797
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    Dexpanthenol

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    Daiichi Fine Chemical C...
    Withdrawn by Holder
    R1-CEP 2006-108 - Rev 00
    Chemical
    2013-02-18
    2020-12-15
    761
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    Dinoprostone

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    KYOWA PHARMA CHEMICAL C...
    Valid
    R1-CEP 2003-029 - Rev 02
    Chemical
    2022-08-09
    1311
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    Glutathione

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    KYOWA HAKKO BIO CO., LT...
    Withdrawn by Holder
    R0-CEP 2014-174 - Rev 00
    Chemical
    2016-06-09
    2021-05-28
    1670
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    Glutathione

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    KYOWA HAKKO BIO CO., LT...
    Valid
    R0-CEP 2020-328 - Rev 00
    Chemical
    2023-01-13
    1670
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    Histidine

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    KYOWA HAKKO BIO CO., LT...
    Valid
    R1-CEP 1999-027 - Rev 04
    Chemical
    2022-05-20
    911
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    Histidine Hydrochloride Monohydrate

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    KYOWA HAKKO BIO CO., LT...
    Valid
    R1-CEP 1999-026 - Rev 05
    Chemical
    2022-06-03
    910
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