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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Kaneka Corporation to the U.S. FDA. Original Data : FDA Website

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    01 (4S,6S)-5, 6-DIHYDRO-4-HYDROXY-6-METHYL-4H-THIENO[2,3-B]THIOPYRAN 7,7-DIOXIDE ("HSOT") (1)

    02 HPG DANE SALT (1)

    03 KPM-1648 (1)

    04 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT TAKASAGO-SHI HYOGO, JAPAN (1)

    05 N-2-[1-(S)-ETHOXYCARBONYL]-N-6-TRIFLUOROACETYL-1-LYSYL-N-2-CARBOXY ANHYDRIDE(EPTL) (1)

    06 N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANINE (ALE) (1)

    07 N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANYL-N-CARBOXY ANHYDRIDE (1)

    08 N2-[1-(S)-ETHOXYCARBONYL 1-3-PHENYLPROPYL]-N6-TRIFLUOROACETYL-L-LYSYL-L-PROLINE. (1)

    09 PCE (1)

    10 PRODUCTION OF PLASMID DNA (1)

    11 PRODUCTION OF PLASMID DNA (DRUG SUBSTANCE, VERSION 2) (1)

    12 PRODUCTION OF PLASMID DNA VERSION 3 (1)

    13 PRODUCTION OF PLASMID DNA VERSION 4 (1)

    14 PRODUCTION OF PLASMID DNA, VERSION 5 (1)

    15 UBIDECARENONE (2)

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    01 KANEKA AMERICA CORP (1)

    02 KANEKA AMERICA LLC (1)

    03 KANEKA CORP (3)

    04 KANEKA CORPORATION JAPAN (5)

    05 KANEKA EUROGENTEC SA (5)

    06 KANEKA SINGAPORE CO PTE LTD (1)

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    01 Belgium (11)

    02 Japan (1)

    03 U.S.A (4)

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    01 Active (11)

    02 Inactive (5)

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    01 Blank (16)

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    (4S,6S)-5, 6-DIHYDRO-4-HYDROXY-6-ME...

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    KANEKA CORPORATION JA...
    Active
    10450
    N/A
    1993-08-30
    II
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      N-2-[1-(S)-ETHOXYCARBONYL]-N-6-TRIF...

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      KANEKA AMERICA CORP
      Active
      14955
      N/A
      2000-09-19
      II
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        N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROP...

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        KANEKA CORP
        Active
        6875
        N/A
        1987-03-19
        II
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        N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROP...

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        KANEKA CORP
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        7995
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        1989-03-22
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        PCE

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        KANEKA CORP
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        12201
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        1996-11-01
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          UBIDECARENONE

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          KANEKA AMERICA LLC
          Inactive
          11180
          N/A
          1994-10-28
          II
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          UBIDECARENONE

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          KANEKA CORPORATION JA...
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          30051
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          2015-11-10
          II
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            HPG DANE SALT

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            KANEKA SINGAPORE CO P...
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            11273
            N/A
            1994-12-28
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            KPM-1648

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            KANEKA CORPORATION JA...
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            11282
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            1995-01-05
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            MANUFACTURING SITE, FACILITIES, PER...

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            KANEKA CORPORATION JA...
            Inactive
            11181
            N/A
            1994-10-28
            II
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