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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Meiji Seika Pharma Co., Ltd. to the U.S. FDA. Original Data : FDA Website

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    01 ARBEKACIN FREE BASE DRUG SUBSTANCE (ME1100) (1)

    02 ARBEKACIN SULFATE DRUG SUBSTANCE (1)

    03 ASHIGARA PLANT (WHERE THP-ADRIAMYCIN IS GR & CONTROLLED) (1)

    04 CEFDITOREN PIVOXIL DRUG SUBSTANCE (1)

    05 DAUNORUBICIN HYDROCHLORIDE (DRUG SUBSTANCE) (1)

    06 DOXORUBICIN HYDROCHLORIDE DRUG SUBSTANCE (1)

    07 FACILITY AND PROCEDURES AT THE KITAKAMI PLANT. (1)

    08 GENTAMICIN SULFATE (1)

    09 KANAMYCIN SULFATE (1)

    10 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ASHIGARA, JAPAN. (1)

    11 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GIFU PLANT, JAPAN. (1)

    12 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KAWASAKI, KANAGAWA, JAPAN. (1)

    13 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OSAKA CITY, JAPAN. (1)

    14 ME1111 DRUG SUBSTANCE (1)

    15 ME3183 (1)

    16 NEOTHRAMYCIN (1)

    17 NEOTHRAMYCIN, BULK (1)

    18 ODAWARA PLANT LOCATED IN KANAGAWA, JAPAN (1)

    19 PENICILLIN G POTASSIUM (1)

    20 PENICILLIN G PROCAINE (1)

    21 PERSONNEL, PROCEDURES, FACILITIES AND CONTROLS (1)

    22 PIRARUBICIN BASE (1)

    23 PIRARUBICIN HCl FOR INJECTION (1)

    24 TAPORFIN SODIUM DRUG SUBSTANCE (1)

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    01 MEIJI SEIKA KAISHA LTD (17)

    02 MEIJI SEIKA PHARMA CO LTD (7)

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    01 Japan (24)

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    01 Active (3)

    02 Inactive (21)

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    01 Complete (1)

    02 Blank (23)

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    ARBEKACIN FREE BASE DRUG SUBSTANCE ...

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    MEIJI SEIKA PHARMA CO...
    Inactive
    26098
    N/A
    2012-06-08
    II
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    ARBEKACIN SULFATE DRUG SUBSTANCE

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    MEIJI SEIKA PHARMA CO...
    Inactive
    25340
    N/A
    2011-09-30
    II
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    CEFDITOREN PIVOXIL DRUG SUBSTANCE

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    MEIJI SEIKA PHARMA CO...
    Inactive
    17482
    N/A
    2004-06-22
    II
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    DAUNORUBICIN HYDROCHLORIDE (DRUG SU...

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    MEIJI SEIKA PHARMA CO...
    Active
    13727
    N/A
    1998-09-01
    II
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    DOXORUBICIN HYDROCHLORIDE DRUG SUBS...

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    MEIJI SEIKA PHARMA CO...
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    13209
    Complete
    2017-10-18
    2015-12-28
    1998-04-30
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    GENTAMICIN SULFATE

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    MEIJI SEIKA KAISHA LT...
    Inactive
    13658
    N/A
    1998-09-01
    II
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    KANAMYCIN SULFATE

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    MEIJI SEIKA KAISHA LT...
    Inactive
    13392
    N/A
    1998-09-01
    II
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    NEOTHRAMYCIN

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    MEIJI SEIKA KAISHA LT...
    Inactive
    4564
    N/A
    1982-05-14
    II
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    NEOTHRAMYCIN, BULK

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    MEIJI SEIKA KAISHA LT...
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    4577
    N/A
    1982-04-30
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    PENICILLIN G POTASSIUM

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    MEIJI SEIKA KAISHA LT...
    Inactive
    13482
    N/A
    1998-09-01
    II
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