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

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    Meiji Seika Pharma
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    4-16, Kyobashi 2-chome, Chuo-ku, Tokyo 104-800
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    • FDA
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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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    • FDA
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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...
    Active
    13209
    Complete
    2017-10-18
    2015-12-28
    1998-04-30
    II
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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...
    Inactive
    4577
    N/A
    1982-04-30
    II
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    • FDA
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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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    PENICILLIN G PROCAINE

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    MEIJI SEIKA KAISHA LT...
    Inactive
    13535
    N/A
    1998-09-01
    II
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    • FDA
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    PIRARUBICIN BASE

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    MEIJI SEIKA KAISHA LT...
    Inactive
    8196
    N/A
    1989-09-05
    II
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    • FDA
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    PIRARUBICIN HCl FOR INJECTION

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    MEIJI SEIKA KAISHA LT...
    Inactive
    8197
    N/A
    1989-09-05
    II
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    • FDA
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    TAPORFIN SODIUM DRUG SUBSTANCE

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    MEIJI SEIKA KAISHA LT...
    Inactive
    14914
    N/A
    2000-06-06
    II
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    • FDA
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    ASHIGARA PLANT (WHERE THP-ADRIAMYCI...

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    MEIJI SEIKA KAISHA LT...
    Inactive
    5026
    N/A
    1983-07-26
    II
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    • FDA
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    FACILITY AND PROCEDURES AT THE KITA...

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    MEIJI SEIKA KAISHA LT...
    Inactive
    9836
    N/A
    1992-08-24
    II
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    • FDA
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    MANUFACTURING SITE, FACILITIES, PER...

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    MEIJI SEIKA KAISHA LT...
    Inactive
    4158
    N/A
    1981-05-11
    II
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    • FDA
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    MANUFACTURING SITE, FACILITIES, PER...

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    MEIJI SEIKA KAISHA LT...
    Inactive
    4480
    N/A
    1982-03-19
    II
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    • FDA
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    MANUFACTURING SITE, FACILITIES, PER...

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    MEIJI SEIKA KAISHA LT...
    Inactive
    5503
    N/A
    1984-08-23
    II
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    • FDA
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    MANUFACTURING SITE, FACILITIES, PER...

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    MEIJI SEIKA KAISHA LT...
    Inactive
    4485
    N/A
    1982-03-19
    II
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    • FDA
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    ME1111 DRUG SUBSTANCE

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    MEIJI SEIKA PHARMA CO...
    Inactive
    26618
    N/A
    2012-11-12
    II
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    • FDA
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    ME3183

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    MEIJI SEIKA PHARMA CO...
    Active
    33320
    N/A
    2018-11-21
    II
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    • FDA
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    ODAWARA PLANT LOCATED IN KANAGAWA, ...

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    MEIJI SEIKA KAISHA LT...
    Inactive
    8198
    N/A
    1989-09-05
    II
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    • FDA
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    PERSONNEL, PROCEDURES, FACILITIES A...

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    MEIJI SEIKA KAISHA LT...
    Inactive
    3757
    N/A
    1980-04-03
    II
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