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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Kyowa Pharma Chemical Co Ltd

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    KYOWA PHARMA CHEMICAL CO LTD

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    Kyowa Pharma Chemical Co Ltd
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    Country
    Country
    Japan
    Address
    Address
    530 CHOKEIJI, TAKAOKA, TOYAMA
    Telephone
    Telephone
    +81-766-21-3456
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    enquiries@pharmacompass.com
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    Dinoprostone

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    USDMF

    Found USDMF

    11274
    Active
    DINOPROSTONE DRUG SUBSTANCE
    1994-12-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-029 - Rev 02
    Valid
    Dinoprostone
    2022-08-09
    Japanese DMF

    Found JDMF

    230MF10070
    Dinoprostone at 530 Chokeiji, Takao...
    2018-06-07
    Written Confirmation

    Close WC

    Application Number
    11274
    R1-CEP 2003-029 - Rev 02
    230MF10070
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DINOPROSTONE DRUG SUBSTANCE
    Dinoprostone
    Dinoprostone at 530 Chokeiji, Takao...
    Issue/Submission Date
    1994-12-27
    2022-08-09
    2018-06-07
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    Latanoprost

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    USDMF

    Found USDMF

    32989
    Active
    LATANOPROST
    2018-08-07
    CEP/COS

    Found CEP/COS

    CEP 2022-107 - Rev 01
    Valid
    Latanoprost
    2024-01-29
    Japanese DMF

    Found JDMF

    220MF10069
    Latanoprost at 530 Chokeiji, Takaok...
    2008-02-25
    Written Confirmation

    Close WC

    Application Number
    32989
    CEP 2022-107 - Rev 01
    220MF10069
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LATANOPROST
    Latanoprost
    Latanoprost at 530 Chokeiji, Takaok...
    Issue/Submission Date
    2018-08-07
    2024-01-29
    2008-02-25
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    Tranexamic Acid

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    USDMF

    Found USDMF

    26128
    Active
    TRANEXAMIC ACID DRUG SUBSTANCE
    2012-06-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-271 - Rev 02
    Valid
    Tranexamic acid
    2022-09-14
    Japanese DMF

    Found JDMF

    224MF10082
    Japanese Pharmacopoeia tranexamic a...
    2012-04-13
    Written Confirmation

    Close WC

    Application Number
    26128
    R1-CEP 2012-271 - Rev 02
    224MF10082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRANEXAMIC ACID DRUG SUBSTANCE
    Tranexamic acid
    Japanese Pharmacopoeia tranexamic a...
    Issue/Submission Date
    2012-06-05
    2022-09-14
    2012-04-13
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    Bimatoprost

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    USDMF

    Found USDMF

    21681
    Active
    BIMATOPROST DRUG SUBSTANCE
    2008-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10081
    Bimatoprost (production only) at 53...
    2012-04-13
    Written Confirmation

    Close WC

    Application Number
    21681
    224MF10081
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BIMATOPROST DRUG SUBSTANCE
    Bimatoprost (production only) at 53...
    Issue/Submission Date
    2008-06-10
    2012-04-13
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    • FDA
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    Olopatadine Hydrochloride

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    USDMF

    Found USDMF

    28389
    Active
    OLOPATADINE HYDROCHLORIDE DRUG SUBS...
    2014-06-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10140
    Japanese Pharmacopoeia olopatadine ...
    2014-07-31
    Written Confirmation

    Close WC

    Application Number
    28389
    226MF10140
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OLOPATADINE HYDROCHLORIDE DRUG SUBS...
    Japanese Pharmacopoeia olopatadine ...
    Issue/Submission Date
    2014-06-16
    2014-07-31
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    Alprostadil Alfadex

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10946
    Japanese Pharmacopoeia alprostadil ...
    2006-11-24
    Written Confirmation

    Close WC

    Application Number
    218MF10946
    Status
     
    Filing Details
    Japanese Pharmacopoeia alprostadil ...
    Issue/Submission Date
    2006-11-24
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    Benidipine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10209
    Japanese Pharmacopoeia benidipine h...
    2013-11-14
    Written Confirmation

    Close WC

    Application Number
    225MF10209
    Status
     
    Filing Details
    Japanese Pharmacopoeia benidipine h...
    Issue/Submission Date
    2013-11-14
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    Benzamidine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10058
    Japanese Pharmacopoeia Pirushikaini...
    2015-03-06
    Written Confirmation

    Close WC

    Application Number
    227MF10058
    Status
     
    Filing Details
    Japanese Pharmacopoeia Pirushikaini...
    Issue/Submission Date
    2015-03-06
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    Cetraxate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10065
    Japanese Pharmacopoeia cetraxate hy...
    2010-02-22
    Written Confirmation

    Close WC

    Application Number
    222MF10065
    Status
     
    Filing Details
    Japanese Pharmacopoeia cetraxate hy...
    Issue/Submission Date
    2010-02-22
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    • FDA
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    Chloroprocaine HCl

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10113
    Japanese Pharmacopoeia procaine hyd...
    2010-03-23
    Written Confirmation

    Close WC

    Application Number
    222MF10113
    Status
     
    Filing Details
    Japanese Pharmacopoeia procaine hyd...
    Issue/Submission Date
    2010-03-23
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    • FDA
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    Dopamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10235
    Japanese Pharmacopoeia dopamine hyd...
    2010-09-30
    Written Confirmation

    Close WC

    Application Number
    222MF10235
    Status
     
    Filing Details
    Japanese Pharmacopoeia dopamine hyd...
    Issue/Submission Date
    2010-09-30
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    • FDA
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    Istradefylline

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10036
    Istradefylline (production only) at...
    2017-02-08
    Written Confirmation

    Close WC

    Application Number
    229MF10036
    Status
     
    Filing Details
    Istradefylline (production only) at...
    Issue/Submission Date
    2017-02-08
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    Lubiprostone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10149
    Lubiprostone (for manufacturing onl...
    2022-11-30
    Written Confirmation

    Close WC

    Application Number
    304MF10149
    Status
     
    Filing Details
    Lubiprostone (for manufacturing onl...
    Issue/Submission Date
    2022-11-30
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    • FDA
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    Oxoiron

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10117
    Japan Pharmaceutical Codex sugar-co...
    2005-05-24
    Written Confirmation

    Close WC

    Application Number
    217MF10117
    Status
     
    Filing Details
    Japan Pharmaceutical Codex sugar-co...
    Issue/Submission Date
    2005-05-24
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    • FDA
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    Pantothenic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10114
    Japanese Pharmacopoeia calcium pant...
    2005-05-24
    Written Confirmation

    Close WC

    Application Number
    217MF10114
    Status
     
    Filing Details
    Japanese Pharmacopoeia calcium pant...
    Issue/Submission Date
    2005-05-24
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    • FDA
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    Riboflavin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10100
    Japanese Pharmacopoeia riboflavin b...
    2009-05-27
    Written Confirmation

    Close WC

    Application Number
    221MF10100
    Status
     
    Filing Details
    Japanese Pharmacopoeia riboflavin b...
    Issue/Submission Date
    2009-05-27
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    • FDA
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    Sodium Valproate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10202
    Japanese Pharmacopoeia sodium valpr...
    2016-10-31
    Written Confirmation

    Close WC

    Application Number
    228MF10202
    Status
     
    Filing Details
    Japanese Pharmacopoeia sodium valpr...
    Issue/Submission Date
    2016-10-31
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    • FDA
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    Valsartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10008
    Japanese Pharmacopoeia valsartan (p...
    2013-01-18
    Written Confirmation

    Close WC

    Application Number
    225MF10008
    Status
     
    Filing Details
    Japanese Pharmacopoeia valsartan (p...
    Issue/Submission Date
    2013-01-18
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    • FDA
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    Dinopuron -EM

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10211
    Dinopuron -EM at 530 Chokeiji, Taka...
    2016-11-09
    Written Confirmation

    Close WC

    Application Number
    228MF10211
    Status
     
    Filing Details
    Dinopuron -EM at 530 Chokeiji, Taka...
    Issue/Submission Date
    2016-11-09
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    Adenosine

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    USDMF

    Caution USDMF

    22824
    Inactive
    GP531T DRUG SUBSTANCE
    2009-05-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22824
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GP531T DRUG SUBSTANCE
    Issue/Submission Date
    2009-05-29
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    D-Panthenol

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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-108 - Rev 00
    Withdrawn by Holder
    Dexpanthenol
    2013-02-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-108 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Dexpanthenol
    Issue/Submission Date
    2013-02-18
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    Misoprostol

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    15044
    Inactive
    MISOPROSTOL DRUG SUBSTANCE
    2000-09-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15044
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MISOPROSTOL DRUG SUBSTANCE
    Issue/Submission Date
    2000-09-13
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    Misoprostol

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    USDMF

    Caution USDMF

    15068
    Inactive
    MISOPROSTOL HPMC DISPERSION
    2000-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15068
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MISOPROSTOL HPMC DISPERSION
    Issue/Submission Date
    2000-09-28
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    • FDA
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    Sulfadimethoxine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    5995
    Inactive
    SULFADIMETHOXINE
    1985-08-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5995
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SULFADIMETHOXINE
    Issue/Submission Date
    1985-08-13
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    Sulfadimethoxine Sodium

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    USDMF

    Caution USDMF

    6003
    Inactive
    SODIUM SULFADIMETHOXINE
    1985-08-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6003
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SODIUM SULFADIMETHOXINE
    Issue/Submission Date
    1985-08-13
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