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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Ckd Bio Corporation

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    01 Acarbose (1)

    02 Clavulanic Acid (4)

    03 Cyclosporine (1)

    04 Daptomycin (1)

    05 Demeclocycline Hydrochloride (1)

    06 Diquafosol (1)

    07 Everolimus (1)

    08 Fumagillin (1)

    09 Lifitegrast (1)

    10 Lithium Clavulanate (1)

    11 Mupirocin (1)

    12 Mycophenolate Mofetil (1)

    13 Peramivir (1)

    14 Rifampicin (1)

    15 Rifamycin (1)

    16 Rifamycin Sodium (1)

    17 Tacrolimus (2)

    18 Teicoplanin (2)

    19 Vancomycin Hydrochloride (1)

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    01 Active (15)

    02 Blank (9)

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    01 Valid (11)

    02 Withdrawn by Holder (1)

    03 Blank (12)

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    01 220MF10038 (1)

    02 223MF10162 (1)

    03 303MF10085 (1)

    04 304MF10069 (1)

    05 304MF10085 (1)

    06 Blank (19)

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    01 Blank (24)

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    Acarbose

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20759
    Active
    ACARBOSE, NON-STERILE BULK DRUG SUB...
    2007-07-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-252 - Rev 02
    Valid
    Acarbose
    2017-01-27
    Japanese DMF

    Found JDMF

    220MF10038
    Acarbose at 8, Chungjeong-ro, Seoda...
    2008-02-05
    Written Confirmation

    Close WC

    Application Number
    20759
    R1-CEP 2007-252 - Rev 02
    220MF10038
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ACARBOSE, NON-STERILE BULK DRUG SUB...
    Acarbose
    Acarbose at 8, Chungjeong-ro, Seoda...
    Issue/Submission Date
    2007-07-31
    2017-01-27
    2008-02-05
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    Clavulanic Acid

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    USDMF

    Found USDMF

    16427
    Active
    CLAVULANATE POTASSIUM
    2003-01-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-180 - Rev 03
    Valid
    Potassium clavulanate, diluted, wit...
    2017-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16427
    R1-CEP 2005-180 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2003-01-21
    2017-01-18
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    Clavulanic Acid

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    USDMF

    Found USDMF

    18362
    Active
    CLAVULANATE POTASSIUM WITH SILICON ...
    2005-04-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-178 - Rev 02
    Valid
    Potassium clavulanate, diluted, wit...
    2017-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18362
    R1-CEP 2005-178 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM WITH SILICON ...
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2005-04-14
    2017-01-20
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    Clavulanic Acid

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    USDMF

    Found USDMF

    18363
    Active
    CLAVULANATE POTASSIUM WITH MICROCRY...
    2005-04-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-183 - Rev 04
    Valid
    Potassium clavulanate
    2017-01-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18363
    R1-CEP 2003-183 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM WITH MICROCRY...
    Potassium clavulanate
    Issue/Submission Date
    2005-04-14
    2017-01-26
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    Cyclosporine

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    USDMF

    Found USDMF

    12214
    Active
    CYCLOSPORINE, NON-STERILE BULK, USP
    1996-10-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-251 - Rev 02
    Valid
    Ciclosporin
    2021-08-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12214
    R1-CEP 2007-251 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CYCLOSPORINE, NON-STERILE BULK, USP
    Ciclosporin
    Issue/Submission Date
    1996-10-25
    2021-08-26
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    Demeclocycline Hydrochloride

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    USDMF

    Found USDMF

    13744
    Active
    DEMECLOCYCLINE HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-313 - Rev 00
    Valid
    Demeclocycline hydrochloride
    2021-11-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13744
    R1-CEP 2015-313 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DEMECLOCYCLINE HYDROCHLORIDE
    Demeclocycline hydrochloride
    Issue/Submission Date
    1998-09-01
    2021-11-16
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    Everolimus

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    USDMF

    Found USDMF

    34106
    Active
    EVEROLIMUS, NON-STERILE API
    2019-08-28
    CEP/COS

    Found CEP/COS

    CEP 2019-321 - Rev 01
    Valid
    Everolimus, 2.0% BHT
    2023-11-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34106
    CEP 2019-321 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    EVEROLIMUS, NON-STERILE API
    Everolimus, 2.0% BHT
    Issue/Submission Date
    2019-08-28
    2023-11-30
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    Rifamycin Sodium

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    USDMF

    Found USDMF

    23616
    Active
    RIFAMYCIN SODIUM NON-STERILE BULK
    2010-03-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-035 - Rev 01
    Valid
    Rifamycin sodium
    2016-11-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23616
    R1-CEP 2010-035 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    RIFAMYCIN SODIUM NON-STERILE BULK
    Rifamycin sodium
    Issue/Submission Date
    2010-03-08
    2016-11-04
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    Tacrolimus

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    USDMF

    Found USDMF

    31097
    Active
    TACROLIMUS NON STERILE API
    2016-10-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10069
    Tacrolimus at 8, Chungjeong-ro, Seo...
    2022-05-06
    Written Confirmation

    Close WC

    Application Number
    31097
    304MF10069
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TACROLIMUS NON STERILE API
    Tacrolimus at 8, Chungjeong-ro, Seo...
    Issue/Submission Date
    2016-10-21
    2022-05-06
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    Teicoplanin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-169 - Rev 03
    Valid
    Teicoplanin, Process A
    2021-12-14
    Japanese DMF

    Found JDMF

    304MF10085
    Teicoplanin at 8, Chungjeong-ro, Se...
    2022-06-08
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-169 - Rev 03
    304MF10085
    Status
    Valid
     
    Filing Details
    Teicoplanin, Process A
    Teicoplanin at 8, Chungjeong-ro, Se...
    Issue/Submission Date
    2021-12-14
    2022-06-08
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