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

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    Kyowa Hakko Bio
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    Ohtemachi Building, 1-6-1,Ohtemachi,Chiyoda-ku, Tokyo, 100-8185, Japan
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    81-3-3282-0974
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    http://www.kyowahakko-bio.co.jp/
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    • FDA
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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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    Dried aluminum hydroxide gel fine "Kyowa Chemical"

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    Kyowa Chemical Industry C...
    2010-02-12
    2005-11-01
    217MF10837
    305 Yashimanishimachi, Ta...
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    Gurishinaru

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    Kyowa Chemical Industry C...
    2009-11-30
    2009-11-30
    221MF10256
    305 Yashimanishimachi, Ta...
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    Heavy Magnesium Oxide JP

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    Kyowa Chemical Industry C...
    2010-01-07
    2010-01-07
    222MF10009
    305 Yashimanishimachi, Ta...
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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 hydrogen phosphate hydra...

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    Kyowa Chemical Industry C...
    2009-04-08
    2009-04-08
    221MF10072
    305 Yashimanishimachi, Ta...
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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 citicoline (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2017-04-14
    2005-06-15
    217MF10245
    1-6-1 Otemachi, Chiyoda-k...
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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 dried aluminum hydroxide gel (pr...

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    Kyowa Chemical Industry C...
    2009-02-09
    2009-02-09
    221MF10033
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia dried aluminum hydroxide gel (pr...

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    Kyowa Chemical Industry C...
    2009-02-09
    2009-02-09
    221MF10030
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia dried aluminum hydroxide gel (pr...

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    Kyowa Chemical Industry C...
    2009-02-09
    2009-02-09
    221MF10031
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia dried aluminum hydroxide gel (pr...

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    Kyowa Chemical Industry C...
    2009-02-09
    2009-02-09
    221MF10032
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia flavin adenine dinucleotide sodi...

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    Kyowa Hakko Bio Co., Ltd.
    2006-06-09
    2005-06-15
    217MF10264
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia flavin adenine dinucleotide sodi...

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    Kyowa Hakko Bio Co., Ltd.
    2016-11-09
    2016-11-09
    228MF10210
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- alanine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2010-10-28
    2010-10-28
    222MF10247
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- arginine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2008-03-14
    2006-08-11
    218MF10702
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- arginine hydrochloride (produ...

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    Kyowa Hakko Bio Co., Ltd.
    2007-06-08
    2007-06-08
    219MF10190
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- aspartic acid (production onl...

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    Kyowa Hakko Bio Co., Ltd.
    2007-06-08
    2007-06-08
    219MF10189
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- glutamine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2015-02-18
    2008-12-04
    220MF10245
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- histidine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2012-01-18
    2012-01-18
    224MF10011
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- histidine hydrochloride hydra...

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    Kyowa Hakko Bio Co., Ltd.
    2012-01-18
    2012-01-18
    224MF10014
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- isoleucine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2006-11-15
    2005-06-15
    217MF10221
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- leucine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2006-11-15
    2005-06-15
    217MF10235
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- lysine acetate (production on...

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    Kyowa Hakko Bio Co., Ltd.
    2012-01-18
    2012-01-18
    224MF10013
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- lysine hydrochloride (product...

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    Kyowa Hakko Bio Co., Ltd.
    2012-01-18
    2012-01-18
    224MF10009
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- phenylalanine (production onl...

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    Kyowa Hakko Bio Co., Ltd.
    2006-11-15
    2005-06-15
    217MF10232
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- proline (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2017-02-08
    2017-02-08
    229MF10028
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- proline (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2012-01-18
    2012-01-18
    224MF10012
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- serine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2008-12-04
    2008-12-04
    220MF10244
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- serine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2016-12-07
    2016-12-07
    228MF10226
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- threonine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2006-11-15
    2005-06-15
    217MF10229
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- threonine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2014-01-08
    2014-01-08
    226MF10004
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- tryptophan (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2006-11-15
    2005-06-15
    217MF10228
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia L- valine (production only)

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    Kyowa Hakko Bio Co., Ltd.
    2006-11-15
    2005-06-15
    217MF10230
    1-6-1 Otemachi, Chiyoda-k...
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    Japanese Pharmacopoeia magnesium carbonate (production ...

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    Kyowa Chemical Industry C...
    2009-10-19
    2009-10-19
    221MF10225
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia magnesium carbonate (production ...

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    Kyowa Chemical Industry C...
    2009-10-19
    2009-10-19
    221MF10226
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia Magnesium Oxide (for manufacturi...

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    Kyowa Chemical Industry C...
    2019-10-18
    2019-10-18
    301MF10078
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia Magnesium Oxide (for manufacturi...

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    Kyowa Chemical Industry C...
    2019-10-18
    2019-10-18
    301MF10079
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia magnesium oxide (production only...

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    Kyowa Chemical Industry C...
    2010-01-07
    2010-01-07
    222MF10004
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia magnesium oxide (production only...

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    Kyowa Chemical Industry C...
    2010-01-07
    2010-01-07
    222MF10005
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia magnesium oxide (production only...

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    Kyowa Chemical Industry C...
    2010-01-07
    2010-01-07
    222MF10006
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia magnesium oxide (production only...

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    Kyowa Chemical Industry C...
    2010-01-07
    2010-01-07
    222MF10007
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia magnesium oxide (production only...

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    Kyowa Chemical Industry C...
    2007-08-06
    2007-08-06
    219MF10258
    305 Yashimanishimachi, Ta...
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    Japanese Pharmacopoeia magnesium oxide (production only...

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    Kyowa Chemical Industry C...
    2010-01-07
    2010-01-07
    222MF10008
    305 Yashimanishimachi, Ta...
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