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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Yonezawa Hamari Chemicals, Ltd.

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    YONEZAWA HAMARI CHEMICALS, LTD.

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    Yonezawa Hamari Chemicals, Ltd.
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    Luliconazole

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    USDMF

    Found USDMF

    23196
    Active
    LULICONAZOLE
    2009-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10131
    Luliconazole "hamari Y" at 1-19-40 ...
    2008-05-20
    Written Confirmation

    Close WC

    Application Number
    23196
    220MF10131
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LULICONAZOLE
    Luliconazole "hamari Y" at 1-19-40 ...
    Issue/Submission Date
    2009-10-18
    2008-05-20
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    Ketoprofen

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2008-209 - Rev 01
    Expired
    Ketoprofen
    2010-09-16
    Japanese DMF

    Found JDMF

    217MF10854
    Japanese Pharmacopoeia ketoprofen (...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2008-209 - Rev 01
    217MF10854
    Status
    Expired
     
    Filing Details
    Ketoprofen
    Japanese Pharmacopoeia ketoprofen (...
    Issue/Submission Date
    2010-09-16
    2005-11-01
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    1190-53-0

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10139
    Buformin hydrochloride \"hamari Y\"...
    2010-04-14
    Written Confirmation

    Close WC

    Application Number
    222MF10139
    Status
     
    Filing Details
    Buformin hydrochloride \"hamari Y\"...
    Issue/Submission Date
    2010-04-14
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    Benfotiamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10852
    Benfotiamine \"Yonezawa\" at 1-19-4...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    217MF10852
    Status
     
    Filing Details
    Benfotiamine \"Yonezawa\" at 1-19-4...
    Issue/Submission Date
    2005-11-01
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    Bucillamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10135
    Bucillamine \"hamari Y\" at 1-19-40...
    2010-04-13
    Written Confirmation

    Close WC

    Application Number
    222MF10135
    Status
     
    Filing Details
    Bucillamine \"hamari Y\" at 1-19-40...
    Issue/Submission Date
    2010-04-13
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    Bucillamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10858
    Outsiders regulations bucillamine (...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    217MF10858
    Status
     
    Filing Details
    Outsiders regulations bucillamine (...
    Issue/Submission Date
    2005-11-01
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    CAS 111011-76-8

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10082
    Efonidipine hydrochloride ethanolat...
    2011-06-17
    Written Confirmation

    Close WC

    Application Number
    223MF10082
    Status
     
    Filing Details
    Efonidipine hydrochloride ethanolat...
    Issue/Submission Date
    2011-06-17
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    Edaravone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10269
    Edaravone at 1-19-40 Nankokita, Sum...
    2009-12-07
    Written Confirmation

    Close WC

    Application Number
    221MF10269
    Status
     
    Filing Details
    Edaravone at 1-19-40 Nankokita, Sum...
    Issue/Submission Date
    2009-12-07
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    Fursultiamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10856
    Japanese Pharmacopoeia hydrochloric...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    217MF10856
    Status
     
    Filing Details
    Japanese Pharmacopoeia hydrochloric...
    Issue/Submission Date
    2005-11-01
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    Guaifenesin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10885
    Japanese Pharmacopoeia guaifenesin ...
    2005-11-07
    Written Confirmation

    Close WC

    Application Number
    217MF10885
    Status
     
    Filing Details
    Japanese Pharmacopoeia guaifenesin ...
    Issue/Submission Date
    2005-11-07
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    • FDA
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    Losartan Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10275
    Losartan potassium at 1-19-40 Nank...
    2010-12-17
    Written Confirmation

    Close WC

    Application Number
    222MF10275
    Status
     
    Filing Details
    Losartan potassium at 1-19-40 Nank...
    Issue/Submission Date
    2010-12-17
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    Loxoprofen Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10105
    Loxoprofensodium hydrate at 1-19-40...
    2015-04-09
    Written Confirmation

    Close WC

    Application Number
    227MF10105
    Status
     
    Filing Details
    Loxoprofensodium hydrate at 1-19-40...
    Issue/Submission Date
    2015-04-09
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    NCGC00181764-01

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10860
    Porapurejinku \"hamari Y\" at 1-19-...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    217MF10860
    Status
     
    Filing Details
    Porapurejinku \"hamari Y\" at 1-19-...
    Issue/Submission Date
    2005-11-01
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    Tamsulosin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10156
    Japanese Pharmacopoeia Tamsulosin H...
    2018-11-14
    Written Confirmation

    Close WC

    Application Number
    230MF10156
    Status
     
    Filing Details
    Japanese Pharmacopoeia Tamsulosin H...
    Issue/Submission Date
    2018-11-14
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    Voglibose

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10861
    Voglibose \"hamari Y\" at 1-19-40 N...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    217MF10861
    Status
     
    Filing Details
    Voglibose \"hamari Y\" at 1-19-40 N...
    Issue/Submission Date
    2005-11-01
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    YH-0915

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10253
    YH-0915 at 1-19-40 Nankokita, Sumin...
    2015-10-09
    Written Confirmation

    Close WC

    Application Number
    227MF10253
    Status
     
    Filing Details
    YH-0915 at 1-19-40 Nankokita, Sumin...
    Issue/Submission Date
    2015-10-09
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    • FDA
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    U bit \"Hamariwai\"

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10851
    U bit \"Hamariwai\" at 1-19-40 Nank...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    217MF10851
    Status
     
    Filing Details
    U bit \"Hamariwai\" at 1-19-40 Nank...
    Issue/Submission Date
    2005-11-01
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    YH-0614

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10141
    YH-0614 at 1-19-40 Nankokita, Sumin...
    2014-07-31
    Written Confirmation

    Close WC

    Application Number
    226MF10141
    Status
     
    Filing Details
    YH-0614 at 1-19-40 Nankokita, Sumin...
    Issue/Submission Date
    2014-07-31
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    Diclofenac Sodium

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    USDMF

    Caution USDMF

    8688
    Inactive
    DICLOFENAC SODIUM
    1990-08-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8688
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    DICLOFENAC SODIUM
    Issue/Submission Date
    1990-08-08
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    Ibuprofen

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    USDMF

    Caution USDMF

    5392
    Inactive
    IBUPROFEN
    1984-05-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5392
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    IBUPROFEN
    Issue/Submission Date
    1984-05-21
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    Levocarnitine

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    USDMF

    Caution USDMF

    5388
    Inactive
    L-CARNITINE
    1984-05-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5388
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    L-CARNITINE
    Issue/Submission Date
    1984-05-17
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    Levocarnitine

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    USDMF

    Caution USDMF

    17647
    Inactive
    L-CARNITINE
    2004-08-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17647
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    L-CARNITINE
    Issue/Submission Date
    2004-08-30
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    • FDA
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    Polaprezinc

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    USDMF

    Caution USDMF

    21259
    Inactive
    POLAPREZINC
    2008-01-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21259
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    POLAPREZINC
    Issue/Submission Date
    2008-01-14
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    [(S)-1,2,3,4-TETRAHYDRO-3-ISO-QUINOLINECARBOXYLIC

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    USDMF

    Caution USDMF

    8541
    Inactive
    [(S)-1,2,3,4-TETRAHYDRO-3-ISO-QUINO...
    1990-04-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8541
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    [(S)-1,2,3,4-TETRAHYDRO-3-ISO-QUINO...
    Issue/Submission Date
    1990-04-24
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    MANUFACTURING SITE, FACILITY PERSONNEL AND GENERAL OPER...

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    USDMF

    Caution USDMF

    11437
    Inactive
    MANUFACTURING SITE, FACILITY PERSON...
    1995-04-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11437
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITY PERSON...
    Issue/Submission Date
    1995-04-06
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    FARGA-3

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    USDMF

    Caution USDMF

    17085
    Inactive
    FARGA-3
    2003-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17085
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FARGA-3
    Issue/Submission Date
    2003-12-29
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