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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Microbiopharm Japan

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    01 Calcitriol (1)

    02 Daunorubicin (2)

    03 Daunorubicin HCl (1)

    04 Doxorubicin Hydrochloride (1)

    05 Epirubicin Hydrochloride (1)

    06 Josamycin (1)

    07 Mitomycin (1)

    08 Paricalcitol (1)

    09 Blank (1)

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    01 Active (4)

    02 Inactive (3)

    03 Blank (3)

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    01 Valid (4)

    02 Blank (6)

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    01 217MF10599 (1)

    02 223MF10117 (1)

    03 223MF10126 (1)

    04 223MF10127 (1)

    05 304MF10094 (1)

    06 304MF10095 (1)

    07 Blank (4)

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    01 Blank (10)

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    • FDA
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    Calcitriol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15128
    Active
    CALCITRIOL
    2000-10-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-228 - Rev 02
    Valid
    Calcitriol
    2021-08-13
    Japanese DMF

    Found JDMF

    223MF10117
    Calcitriol at 1-3-1 Kyobashi, Chuo-...
    2011-07-25
    Written Confirmation

    Close WC

    Application Number
    15128
    R1-CEP 2008-228 - Rev 02
    223MF10117
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CALCITRIOL
    Calcitriol
    Calcitriol at 1-3-1 Kyobashi, Chuo-...
    Issue/Submission Date
    2000-10-31
    2021-08-13
    2011-07-25
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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    13211
    Active
    DOXORUBICIN HYDROCHLORIDE
    1998-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-200 - Rev 05
    Valid
    Doxorubicin Hydrochloride
    2017-03-03
    Japanese DMF

    Found JDMF

    223MF10126
    Day stations doxorubicin hydrochlor...
    2011-08-09
    Written Confirmation

    Close WC

    Application Number
    13211
    R1-CEP 2004-200 - Rev 05
    223MF10126
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOXORUBICIN HYDROCHLORIDE
    Doxorubicin Hydrochloride
    Day stations doxorubicin hydrochlor...
    Issue/Submission Date
    1998-04-30
    2017-03-03
    2011-08-09
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    Epirubicin Hydrochloride

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    USDMF

    Found USDMF

    22018
    Active
    EPIRUBICIN HYDROCHLORIDE
    2008-09-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-025 - Rev 04
    Valid
    Epirubicin hydrochloride
    2021-10-25
    Japanese DMF

    Found JDMF

    223MF10127
    Day stations epirubicin hydrochlori...
    2011-08-09
    Written Confirmation

    Close WC

    Application Number
    22018
    R1-CEP 2008-025 - Rev 04
    223MF10127
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    EPIRUBICIN HYDROCHLORIDE
    Epirubicin hydrochloride
    Day stations epirubicin hydrochlori...
    Issue/Submission Date
    2008-09-19
    2021-10-25
    2011-08-09
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    Josamycin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-502 - Rev 00
    Valid
    Josamycin
    2023-06-29
    Japanese DMF

    Found JDMF

    217MF10599
    Day stations josamycin at 1-3-1 Kyo...
    2005-09-14
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-502 - Rev 00
    217MF10599
    Status
    Valid
     
    Filing Details
    Josamycin
    Day stations josamycin at 1-3-1 Kyo...
    Issue/Submission Date
    2023-06-29
    2005-09-14
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    Daunorubicin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10095
    Crude Daunorubicin Hydrochloride at...
    2022-07-06
    Written Confirmation

    Close WC

    Application Number
    304MF10095
    Status
     
    Filing Details
    Crude Daunorubicin Hydrochloride at...
    Issue/Submission Date
    2022-07-06
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    Daunorubicin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10094
    Crude Daunorubicin Hydrochloride at...
    2022-07-06
    Written Confirmation

    Close WC

    Application Number
    304MF10094
    Status
     
    Filing Details
    Crude Daunorubicin Hydrochloride at...
    Issue/Submission Date
    2022-07-06
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    Daunorubicin HCl

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    USDMF

    Found USDMF

    11879
    Active
    DAUNORUBICIN HYDROCHLORIDE (CRUDE)
    1996-02-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11879
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DAUNORUBICIN HYDROCHLORIDE (CRUDE)
    Issue/Submission Date
    1996-02-29
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    Mitomycin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13785
    Inactive
    MITOMYCIN
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13785
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MITOMYCIN
    Issue/Submission Date
    1998-09-01
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    Paricalcitol

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    USDMF

    Caution USDMF

    27145
    Inactive
    PARICALCITOL, USP
    2013-05-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27145
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PARICALCITOL, USP
    Issue/Submission Date
    2013-05-04
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    (1S,3R)-1,3-BIS(TERT-BUTYLDIMETHYLSILYLOXY) ANDROST-5-E...

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    USDMF

    Caution USDMF

    12028
    Inactive
    (1S,3R)-1,3-BIS(TERT-BUTYLDIMETHYLS...
    1996-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12028
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    (1S,3R)-1,3-BIS(TERT-BUTYLDIMETHYLS...
    Issue/Submission Date
    1996-07-08
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