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

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    01 Afatinib (1)

    02 Alectinib Hydrochloride (1)

    03 Anastrozole (1)

    04 Belinostat (1)

    05 Bendamustine Hydrochloride (1)

    06 Bicalutamide (1)

    07 Bortezomib (1)

    08 Buflomedil (1)

    09 Busulfan (1)

    10 Cabazitaxel (1)

    11 Carboplatin (1)

    12 Carfilzomib (1)

    13 Cisplatin (1)

    14 Decitabine (1)

    15 Docetaxel (2)

    16 Erlotinib Hydrochloride (1)

    17 Gefitinib (1)

    18 Gemcitabine (3)

    19 Ibrutinib (1)

    20 Imatinib Mesylate (1)

    21 Irinotecan Hydrochloride (1)

    22 Letrozole (1)

    23 Levobupivacaine (1)

    24 Metaxalone (1)

    25 Oxaliplatin (1)

    26 Paclitaxel (1)

    27 Pemetrexed Disodium (1)

    28 Plerixafor (1)

    29 Ribociclib (1)

    30 Ropivacaine Hydrochloride (2)

    31 Sugammadex Sodium (1)

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    01 Active (9)

    02 Inactive (1)

    03 Blank (25)

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    01 Valid (13)

    02 Withdrawn by Holder (3)

    03 Blank (19)

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    01 Blank (35)

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    01 WC-0115 (19)

    02 WC-0115A3 (6)

    03 Blank (10)

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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

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    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

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    Japanese DMF

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    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

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    Japanese DMF

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    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

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    Japanese DMF

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    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

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    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

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    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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