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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Meiji Seika Pharma

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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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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    13209
    Active
    DOXORUBICIN HYDROCHLORIDE DRUG SUBS...
    1998-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-151 - Rev 03
    Valid
    Doxorubicin Hydrochloride
    2020-04-02
    Japanese DMF

    Found JDMF

    302MF10073
    Doxorubicin Hydrochloride at 2-4-16...
    2020-07-01
    Written Confirmation

    Close WC

    Application Number
    13209
    R1-CEP 2003-151 - Rev 03
    302MF10073
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    DOXORUBICIN HYDROCHLORIDE DRUG SUBS...
    Doxorubicin Hydrochloride
    Doxorubicin Hydrochloride at 2-4-16...
    Issue/Submission Date
    1998-04-30
    2020-04-02
    2020-07-01
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    Daunorubicin HCl

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    USDMF

    Found USDMF

    13727
    Active
    DAUNORUBICIN HYDROCHLORIDE (DRUG SU...
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-061 - Rev 02
    Valid
    Daunorubicin Hydrochloride
    2023-01-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13727
    R1-CEP 2003-061 - Rev 02
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    DAUNORUBICIN HYDROCHLORIDE (DRUG SU...
    Daunorubicin Hydrochloride
    Issue/Submission Date
    1998-09-01
    2023-01-03
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    Cefditoren Pivoxil

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    USDMF

    Caution USDMF

    17482
    Inactive
    CEFDITOREN PIVOXIL DRUG SUBSTANCE
    2004-06-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10072
    Cefditoren Pivoxil at 2-4-16 Kyobas...
    2020-06-26
    Written Confirmation

    Close WC

    Application Number
    17482
    302MF10072
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFDITOREN PIVOXIL DRUG SUBSTANCE
    Cefditoren Pivoxil at 2-4-16 Kyobas...
    Issue/Submission Date
    2004-06-22
    2020-06-26
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    Vitamin B12

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2004-293 - Rev 01
    Expired
    Cyanocobalamin
    2011-05-26
    Japanese DMF

    Found JDMF

    217MF10729
    Day stations cyanocobalamin at 2-4-...
    2005-10-07
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2004-293 - Rev 01
    217MF10729
    Status
    Expired
     
    Filing Details
    Cyanocobalamin
    Day stations cyanocobalamin at 2-4-...
    Issue/Submission Date
    2011-05-26
    2005-10-07
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    Ampicillin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11156
    Ampicillin sodium at 2-4-16 Kyobash...
    2005-12-12
    Written Confirmation

    Close WC

    Application Number
    217MF11156
    Status
     
    Filing Details
    Ampicillin sodium at 2-4-16 Kyobash...
    Issue/Submission Date
    2005-12-12
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    Doxorubicin Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10960
    Doxorubicin hydrochloride at 2-4-16...
    2006-12-01
    Written Confirmation

    Close WC

    Application Number
    218MF10960
    Status
     
    Filing Details
    Doxorubicin hydrochloride at 2-4-16...
    Issue/Submission Date
    2006-12-01
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    Sodium Hyaluronate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-112 - Rev 00
    Valid
    Sodium hyaluronate, Intrinsic visco...
    2012-07-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-112 - Rev 00
    Status
    Valid
     
    Filing Details
    Sodium hyaluronate, Intrinsic visco...
    Issue/Submission Date
    2012-07-10
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    ME3183

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    USDMF

    Found USDMF

    33320
    Active
    ME3183
    2018-11-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33320
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    ME3183
    Issue/Submission Date
    2018-11-21
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    Arbekacin

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    USDMF

    Caution USDMF

    26098
    Inactive
    ARBEKACIN FREE BASE DRUG SUBSTANCE ...
    2012-06-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26098
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ARBEKACIN FREE BASE DRUG SUBSTANCE ...
    Issue/Submission Date
    2012-06-08
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    Colistin Sulfate

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 1998-091 - Rev 00
    Withdrawn by Holder
    Colistin sulfate
    2007-11-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1998-091 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Colistin sulfate
    Issue/Submission Date
    2007-11-23
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    Gentamicin Sulfate

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    USDMF

    Caution USDMF

    13658
    Inactive
    GENTAMICIN SULFATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13658
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    GENTAMICIN SULFATE
    Issue/Submission Date
    1998-09-01
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    Habekacin

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    USDMF

    Caution USDMF

    25340
    Inactive
    ARBEKACIN SULFATE DRUG SUBSTANCE
    2011-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25340
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ARBEKACIN SULFATE DRUG SUBSTANCE
    Issue/Submission Date
    2011-09-30
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    Kanamycin Sulfate

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    USDMF

    Caution USDMF

    13392
    Inactive
    KANAMYCIN SULFATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13392
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    KANAMYCIN SULFATE
    Issue/Submission Date
    1998-09-01
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    Neothramycins

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    USDMF

    Caution USDMF

    4564
    Inactive
    NEOTHRAMYCIN
    1982-05-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4564
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    NEOTHRAMYCIN
    Issue/Submission Date
    1982-05-14
    ASK
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    Neothramycins

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    USDMF

    Caution USDMF

    4577
    Inactive
    NEOTHRAMYCIN, BULK
    1982-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4577
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    NEOTHRAMYCIN, BULK
    Issue/Submission Date
    1982-04-30
    ASK
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    • FDA
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    Penicillin G Potassium

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    USDMF

    Caution USDMF

    13482
    Inactive
    PENICILLIN G POTASSIUM
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13482
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PENICILLIN G POTASSIUM
    Issue/Submission Date
    1998-09-01
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    Penicillin G Procaine

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    USDMF

    Caution USDMF

    13535
    Inactive
    PENICILLIN G PROCAINE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13535
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PENICILLIN G PROCAINE
    Issue/Submission Date
    1998-09-01
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    Pirarubicin HCl

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    8197
    Inactive
    PIRARUBICIN HCl FOR INJECTION
    1989-09-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8197
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PIRARUBICIN HCl FOR INJECTION
    Issue/Submission Date
    1989-09-05
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    Talaporfin

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    USDMF

    Caution USDMF

    14914
    Inactive
    TAPORFIN SODIUM DRUG SUBSTANCE
    2000-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14914
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    TAPORFIN SODIUM DRUG SUBSTANCE
    Issue/Submission Date
    2000-06-06
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    Therarubicin Tn

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    USDMF

    Caution USDMF

    8196
    Inactive
    PIRARUBICIN BASE
    1989-09-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8196
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PIRARUBICIN BASE
    Issue/Submission Date
    1989-09-05
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    PERSONNEL, PROCEDURES, FACILITIES AND CONTROLS

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    USDMF

    Caution USDMF

    3757
    Inactive
    PERSONNEL, PROCEDURES, FACILITIES A...
    1980-04-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3757
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PERSONNEL, PROCEDURES, FACILITIES A...
    Issue/Submission Date
    1980-04-03
    ASK
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    4158
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1981-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4158
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1981-05-11
    ASK
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Caution USDMF

    4480
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1982-03-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4480
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1982-03-19
    ASK
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Caution USDMF

    4485
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1982-03-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4485
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1982-03-19
    ASK
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    ASHIGARA PLANT (WHERE THP-ADRIAMYCIN IS MFGR & CONTROLL...

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    See Less

    USDMF

    Caution USDMF

    5026
    Inactive
    ASHIGARA PLANT (WHERE THP-ADRIAMYCI...
    1983-07-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5026
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ASHIGARA PLANT (WHERE THP-ADRIAMYCI...
    Issue/Submission Date
    1983-07-26
    ASK
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    5503
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1984-08-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5503
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1984-08-23
    ASK
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    ODAWARA PLANT LOCATED IN KANAGAWA, JAPAN

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    USDMF

    Caution USDMF

    8198
    Inactive
    ODAWARA PLANT LOCATED IN KANAGAWA, ...
    1989-09-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8198
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ODAWARA PLANT LOCATED IN KANAGAWA, ...
    Issue/Submission Date
    1989-09-05
    ASK
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    FACILITY AND PROCEDURES AT THE KITAKAMI PLANT.

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    9836
    Inactive
    FACILITY AND PROCEDURES AT THE KITA...
    1992-08-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9836
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FACILITY AND PROCEDURES AT THE KITA...
    Issue/Submission Date
    1992-08-24
    ASK
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    ME1111 DRUG SUBSTANCE

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    USDMF

    Caution USDMF

    26618
    Inactive
    ME1111 DRUG SUBSTANCE
    2012-11-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26618
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ME1111 DRUG SUBSTANCE
    Issue/Submission Date
    2012-11-12
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