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    List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Kyowa Pharma Chemical Co Ltd to the Review Authority in Japan (PMDA). Original Data : PMDA

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    01 Bimatoprost (production only) (1)

    02 Dinoprostone (1)

    03 Dinopuron -EM (1)

    04 Istradefylline (production only) (1)

    05 Japan Pharmaceutical Codex sugar-containing iron oxide (production only) (1)

    06 Japanese Pharmacopoeia Pirushikainido hydrochloride hydrate (production only) (1)

    07 Japanese Pharmacopoeia alprostadil alpha dexfenfluramine (production only) (1)

    08 Japanese Pharmacopoeia benidipine hydrochloride (production only) (1)

    09 Japanese Pharmacopoeia calcium pantothenate (production only) (1)

    10 Japanese Pharmacopoeia cetraxate hydrochloride (production only) (1)

    11 Japanese Pharmacopoeia dopamine hydrochloride (production only) (1)

    12 Japanese Pharmacopoeia olopatadine hydrochloride (production only) (1)

    13 Japanese Pharmacopoeia procaine hydrochloride (production only) (1)

    14 Japanese Pharmacopoeia riboflavin butyric acid ester (production only) (1)

    15 Japanese Pharmacopoeia sodium valproate (production only) (1)

    16 Japanese Pharmacopoeia tranexamic acid (production only) (1)

    17 Japanese Pharmacopoeia valsartan (production only) (1)

    18 Latanoprost (1)

    19 Lubiprostone (for manufacturing only) (1)

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    01 Kyowa Pharma Chemical Co., Ltd. (19)

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    01 Japan (19)

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    Bimatoprost (production only)

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    Kyowa Pharma Chemical Co....
    2023-02-08
    2012-04-13
    224MF10081
    530 Chokeiji, Takaoka, To...
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    Dinoprostone

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    Kyowa Pharma Chemical Co....
    2018-06-07
    2018-06-07
    230MF10070
    530 Chokeiji, Takaoka, To...
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    Istradefylline (production only)

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    Kyowa Pharma Chemical Co....
    2017-02-08
    2017-02-08
    229MF10036
    530 Chokeiji, Takaoka, To...
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    Japan Pharmaceutical Codex sugar-containing iron oxide ...

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    Kyowa Pharma Chemical Co....
    2009-04-08
    2005-05-24
    217MF10117
    530 Chokeiji, Takaoka, To...
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    Japanese Pharmacopoeia alprostadil alpha dexfenfluramin...

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    Kyowa Pharma Chemical Co....
    2006-11-24
    2006-11-24
    218MF10946
    530 Chokeiji, Takaoka, To...
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    Japanese Pharmacopoeia benidipine hydrochloride (produc...

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    Kyowa Pharma Chemical Co....
    2013-11-14
    2013-11-14
    225MF10209
    530 Chokeiji, Takaoka, To...
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    Japanese Pharmacopoeia calcium pantothenate (production...

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    Kyowa Pharma Chemical Co....
    2006-10-20
    2005-05-24
    217MF10114
    530 Chokeiji, Takaoka, To...
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    Japanese Pharmacopoeia cetraxate hydrochloride (product...

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    Kyowa Pharma Chemical Co....
    2010-02-22
    2010-02-22
    222MF10065
    530 Chokeiji, Takaoka, To...
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    Japanese Pharmacopoeia dopamine hydrochloride (producti...

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    Kyowa Pharma Chemical Co....
    2016-12-05
    2010-09-30
    222MF10235
    530 Chokeiji, Takaoka, To...
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    Japanese Pharmacopoeia olopatadine hydrochloride (produ...

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    Kyowa Pharma Chemical Co....
    2016-06-06
    2014-07-31
    226MF10140
    530 Chokeiji, Takaoka, To...
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