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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fresenius Kabi Oncology Limited

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    FRESENIUS KABI ONCOLOGY LIMITED

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    Fresenius Kabi Oncology Limited
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    Country
    Country
    India
    Address
    Address
    Echelon Institutional Area Plot No-11, Sector - 32 Gurgaon Pin code - 122001 Haryana
    Telephone
    Telephone
    Client Email
    Email
    enquiries@pharmacompass.com
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    Website
    https://www.fresenius-kabi-oncology.com/company.html
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    Afatinib

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    USDMF

    Found USDMF

    30927
    Active
    AFATINIB DIMALEATE
    2016-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Afatinib Dimaleate IH
    2022-09-30
    Application Number
    30927
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    AFATINIB DIMALEATE
    Afatinib Dimaleate IH
    Issue/Submission Date
    2016-12-31
    2022-09-30
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    Alectinib Hydrochloride

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    USDMF

    Found USDMF

    33869
    Active
    ALECTINIB HYDROCHLORIDE
    2019-06-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Alectinib Hydrochloride IH
    2022-09-30
    Application Number
    33869
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    ALECTINIB HYDROCHLORIDE
    Alectinib Hydrochloride IH
    Issue/Submission Date
    2019-06-12
    2022-09-30
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    Carfilzomib

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    USDMF

    Found USDMF

    29750
    Active
    CARFILZOMIB
    2016-01-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Carfilzomib IH
    2022-09-30
    Application Number
    29750
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    CARFILZOMIB
    Carfilzomib IH
    Issue/Submission Date
    2016-01-30
    2022-09-30
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    Ibrutinib

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    USDMF

    Found USDMF

    31199
    Active
    IBRUTINIB
    2017-05-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Ibrutinib IH
    2022-09-30
    Application Number
    31199
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    IBRUTINIB
    Ibrutinib IH
    Issue/Submission Date
    2017-05-12
    2022-09-30
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    Plerixafor

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    USDMF

    Found USDMF

    32615
    Active
    PLERIXAFOR
    2018-05-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Plerixafor IH
    2022-09-30
    Application Number
    32615
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    PLERIXAFOR
    Plerixafor IH
    Issue/Submission Date
    2018-05-18
    2022-09-30
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    Ropivacaine Hydrochloride

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    USDMF

    Found USDMF

    36233
    Active
    ROPIVACAINE HYDROCHLORIDE ANHYDROUS
    2021-10-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-130 - Rev 00
    Valid
    Ropivacaine hydrochloride monohydra...
    2021-09-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36233
    R0-CEP 2021-130 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ROPIVACAINE HYDROCHLORIDE ANHYDROUS
    Ropivacaine hydrochloride monohydra...
    Issue/Submission Date
    2021-10-05
    2021-09-14
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    Belinostat

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    USDMF

    Found USDMF

    32260
    Active
    BELINOSTAT
    2018-01-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Belinostat IH
    2019-07-08
    Application Number
    32260
    Indian CDSCO WC-0115
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-07
    Filing Details
    BELINOSTAT
    Belinostat IH
    Issue/Submission Date
    2018-01-05
    2019-07-08
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    Bicalutamide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-369 - Rev 00
    Valid
    Bicalutamide
    2021-05-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Bicalutamide (USP/IH)
    2019-07-08
    Application Number
    R1-CEP 2012-369 - Rev 00
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Bicalutamide
    Bicalutamide (USP/IH)
    Issue/Submission Date
    2021-05-20
    2019-07-08
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    Busulfan

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2010-374 - Rev 07
    Valid
    Busulfan
    2023-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Busulfan (USP/EP/BP)
    2019-07-08
    Application Number
    CEP 2010-374 - Rev 07
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Busulfan
    Busulfan (USP/EP/BP)
    Issue/Submission Date
    2023-10-13
    2019-07-08
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    Carboplatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-282 - Rev 13
    Valid
    Carboplatin
    2022-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Carboplatin (Ph. Eur./USP)
    2019-07-08
    Application Number
    R1-CEP 2001-282 - Rev 13
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Carboplatin
    Carboplatin (Ph. Eur./USP)
    Issue/Submission Date
    2022-03-07
    2019-07-08
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    Docetaxel

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2012-293 - Rev 02
    Valid
    Docetaxel
    2023-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Docetaxel Anhydrous(USP)/Docetaxel ...
    2019-07-08
    Application Number
    CEP 2012-293 - Rev 02
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Docetaxel
    Docetaxel Anhydrous(USP)/Docetaxel ...
    Issue/Submission Date
    2023-11-17
    2019-07-08
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    Gemcitabine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-131 - Rev 04
    Valid
    Gemcitabine hydrochloride
    2022-02-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Gemcitabine Hydrochloride (Ph. Eur....
    2019-07-08
    Application Number
    R1-CEP 2008-131 - Rev 04
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Gemcitabine hydrochloride
    Gemcitabine Hydrochloride (Ph. Eur....
    Issue/Submission Date
    2022-02-11
    2019-07-08
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    Irinotecan Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2017-234 - Rev 02
    Valid
    Irinotecan hydrochloride trihydrate
    2022-09-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Irinotecan Hydrochloride Trihydrate...
    2019-07-08
    Application Number
    R0-CEP 2017-234 - Rev 02
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Irinotecan hydrochloride trihydrate
    Irinotecan Hydrochloride Trihydrate...
    Issue/Submission Date
    2022-09-02
    2019-07-08
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    Letrozole

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-338 - Rev 03
    Valid
    Letrozole
    2023-01-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Letrozole (USP/Ph. Eur./BP)
    2019-07-08
    Application Number
    R1-CEP 2007-338 - Rev 03
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Letrozole
    Letrozole (USP/Ph. Eur./BP)
    Issue/Submission Date
    2023-01-09
    2019-07-08
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    Oxaliplatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-193 - Rev 05
    Valid
    Oxaliplatin
    2021-09-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Oxaliplatin (USP/Ph. Eur./BP)
    2019-07-08
    Application Number
    R1-CEP 2007-193 - Rev 05
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Oxaliplatin
    Oxaliplatin (USP/Ph. Eur./BP)
    Issue/Submission Date
    2021-09-24
    2019-07-08
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    Paclitaxel

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-181 - Rev 10
    Valid
    Paclitaxel, Semi-synthetic process
    2022-10-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Paclitaxel (Ph. Eur.) (Semi-synthet...
    2019-07-08
    Application Number
    R1-CEP 2008-181 - Rev 10
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Paclitaxel, Semi-synthetic process
    Paclitaxel (Ph. Eur.) (Semi-synthet...
    Issue/Submission Date
    2022-10-17
    2019-07-08
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    Cabazitaxel

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Cabazitaxel IH
    2022-09-30
    Application Number
    Indian CDSCO WC-0115A3
    Status
     
    Valid
    2025-09-15
    Filing Details
    Cabazitaxel IH
    Issue/Submission Date
    2022-09-30
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-189 - Rev 04
    Valid
    Docetaxel trihydrate
    2023-02-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-189 - Rev 04
    Status
    Valid
     
    Filing Details
    Docetaxel trihydrate
    Issue/Submission Date
    2023-02-16
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    Gemcitabine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-271 - Rev 00
    Valid
    Gemcitabine hydrochloride, Alternat...
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2023-271 - Rev 00
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride, Alternat...
    Issue/Submission Date
    2023-12-06
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    Gemcitabine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-080 - Rev 01
    Valid
    Gemcitabine hydrochloride, Alternat...
    2019-10-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-080 - Rev 01
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride, Alternat...
    Issue/Submission Date
    2019-10-08
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    Ribociclib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35027
    Active
    RIBOCICLIB SUCCINATE
    2020-09-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35027
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIBOCICLIB SUCCINATE
    Issue/Submission Date
    2020-09-10
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    Sugammadex Sodium

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    USDMF

    Found USDMF

    33870
    Active
    SUGAMMADEX SODIUM
    2019-06-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33870
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SUGAMMADEX SODIUM
    Issue/Submission Date
    2019-06-14
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    Anastrozole

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Anastrozole (USP/IH)
    2019-07-08
    Application Number
    Indian CDSCO WC-0115
    Status
     
    Expired
    2022-07-07
    Filing Details
    Anastrozole (USP/IH)
    Issue/Submission Date
    2019-07-08
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    Bendamustine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Bendamustine Hydrochloride (IH)
    2019-07-08
    Application Number
    Indian CDSCO WC-0115
    Status
     
    Expired
    2022-07-07
    Filing Details
    Bendamustine Hydrochloride (IH)
    Issue/Submission Date
    2019-07-08
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    Bortezomib

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Bortezomib IH
    2019-07-08
    Application Number
    Indian CDSCO WC-0115
    Status
     
    Expired
    2022-07-07
    Filing Details
    Bortezomib IH
    Issue/Submission Date
    2019-07-08
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    Buflomedil

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-346 - Rev 00
    Withdrawn by Holder
    Buflomedil Hydrochloride
    2013-04-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2010-346 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
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