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

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    CKD Bio Corporation
    korearepublicofnew Flag
    Country
    Country
    South Korea
    Address
    Address
    CKD building, 8, Chungjeong-ro, Seodaemun-gu, Seoul,
    Telephone
    Telephone
    +82 221940555
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    enquiries@pharmacompass.com
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    http://www.ckdbio.com/
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    • FDA
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    Acarbose

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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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    Teicoplanin

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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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    • FDA
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    31002
    Active
    VANCOMYCIN HYDROCHLORIDE
    2016-09-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-265 - Rev 00
    Valid
    Vancomycin hydrochloride
    2019-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31002
    R0-CEP 2017-265 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Issue/Submission Date
    2016-09-20
    2019-08-12
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    Teicoplanin

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2009-168 - Rev 00
    Withdrawn by Holder
    Teicoplanin
    2011-04-04
    Japanese DMF

    Found JDMF

    223MF10162
    Teicoplanin at 8, Chungjeong-ro, Se...
    2011-11-14
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2009-168 - Rev 00
    223MF10162
    Status
    Withdrawn by Holder
     
    Filing Details
    Teicoplanin
    Teicoplanin at 8, Chungjeong-ro, Se...
    Issue/Submission Date
    2011-04-04
    2011-11-14
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    • FDA
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    Clavulanic Acid

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-179 - Rev 03
    Valid
    Potassium clavulanate, diluted, wit...
    2017-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-179 - Rev 03
    Status
    Valid
     
    Filing Details
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2017-02-09
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    • FDA
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    Daptomycin

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    USDMF

    Found USDMF

    34757
    Active
    DAPTOMYCIN
    2020-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34757
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DAPTOMYCIN
    Issue/Submission Date
    2020-03-27
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    Mycophenolate Mofetil

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    USDMF

    Found USDMF

    24981
    Active
    MYCOPHENOLATE MOFETIL, NON-STERILE ...
    2011-05-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24981
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MYCOPHENOLATE MOFETIL, NON-STERILE ...
    Issue/Submission Date
    2011-05-16
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    Peramivir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35077
    Active
    PERAMIVIR HYDRATE
    2020-08-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35077
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PERAMIVIR HYDRATE
    Issue/Submission Date
    2020-08-21
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    Rifampicin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13663
    Active
    RIFAMPIN
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13663
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RIFAMPIN
    Issue/Submission Date
    1998-09-01
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    Rifamycin

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    USDMF

    Found USDMF

    26159
    Active
    RIFAMYCIN O, NON-STERILE API
    2012-06-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26159
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIFAMYCIN O, NON-STERILE API
    Issue/Submission Date
    2012-06-15
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    • FDA
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    Tacrolimus

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10085
    Tacrolimus at 8, Chungjeong-ro, Seo...
    2021-06-03
    Written Confirmation

    Close WC

    Application Number
    303MF10085
    Status
     
    Filing Details
    Tacrolimus at 8, Chungjeong-ro, Seo...
    Issue/Submission Date
    2021-06-03
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    • FDA
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    Diquafosol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Fumagillin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Lifitegrast

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Lithium Clavulanate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Mupirocin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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