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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
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    Address
    Echelon Institutional Area Plot No-11, Sector - 32 Gurgaon Pin code - 122001 Haryana
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    enquiries@pharmacompass.com
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    https://www.fresenius-kabi-oncology.com/company.html
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    Afatinib

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    USDMF

    Caution USDMF

    30927
    Inactive
    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 at D-35, Indu...
    2022-09-30
    Application Number
    30927
    Indian CDSCO WC-0115A3
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    AFATINIB DIMALEATE
    Afatinib Dimaleate IH at D-35, Indu...
    Issue/Submission Date
    2016-12-31
    2022-09-30
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    Alectinib Hydrochloride

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    USDMF

    Caution USDMF

    33869
    Inactive
    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 at D-35,...
    2022-09-30
    Application Number
    33869
    Indian CDSCO WC-0115A3
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    ALECTINIB HYDROCHLORIDE
    Alectinib Hydrochloride IH at D-35,...
    Issue/Submission Date
    2019-06-12
    2022-09-30
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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) at D-35, Indu...
    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) at D-35, Indu...
    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) at D-35, Indus...
    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) at D-35, Indus...
    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) at D-35,...
    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) at D-35,...
    Issue/Submission Date
    2022-03-07
    2019-07-08
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    Carfilzomib

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    USDMF

    Caution USDMF

    29750
    Inactive
    CARFILZOMIB
    2016-01-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Carfilzomib IH at D-35, Industrial ...
    2022-09-30
    Application Number
    29750
    Indian CDSCO WC-0115A3
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    CARFILZOMIB
    Carfilzomib IH at D-35, Industrial ...
    Issue/Submission Date
    2016-01-30
    2022-09-30
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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 2012-080 - Rev 01
    Valid
    Gemcitabine hydrochloride, Alternat...
    2019-10-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Gemcitabine Hydrochloride (Ph. Eur....
    2019-07-08
    Application Number
    R1-CEP 2012-080 - Rev 01
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Gemcitabine hydrochloride, Alternat...
    Gemcitabine Hydrochloride (Ph. Eur....
    Issue/Submission Date
    2019-10-08
    2019-07-08
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    Ibrutinib

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    USDMF

    Caution USDMF

    31199
    Inactive
    IBRUTINIB
    2017-05-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Ibrutinib IH at D-35, Industrial Ar...
    2022-09-30
    Application Number
    31199
    Indian CDSCO WC-0115A3
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    IBRUTINIB
    Ibrutinib IH at D-35, Industrial Ar...
    Issue/Submission Date
    2017-05-12
    2022-09-30
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    Irinotecan Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2017-234 - Rev 03
    Valid
    Irinotecan hydrochloride trihydrate
    2024-04-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Irinotecan Hydrochloride Trihydrate...
    2019-07-08
    Application Number
    CEP 2017-234 - Rev 03
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Irinotecan hydrochloride trihydrate
    Irinotecan Hydrochloride Trihydrate...
    Issue/Submission Date
    2024-04-22
    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) at D-35...
    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) at D-35...
    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

    CEP 2007-193 - Rev 06
    Valid
    Oxaliplatin
    2024-06-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Oxaliplatin (USP/Ph. Eur./BP) at D-...
    2019-07-08
    Application Number
    CEP 2007-193 - Rev 06
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Oxaliplatin
    Oxaliplatin (USP/Ph. Eur./BP) at D-...
    Issue/Submission Date
    2024-06-04
    2019-07-08
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    Paclitaxel

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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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    Plerixafor

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    USDMF

    Caution USDMF

    32615
    Inactive
    PLERIXAFOR
    2018-05-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Plerixafor IH at D-35, Industrial A...
    2022-09-30
    Application Number
    32615
    Indian CDSCO WC-0115A3
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    PLERIXAFOR
    Plerixafor IH at D-35, Industrial A...
    Issue/Submission Date
    2018-05-18
    2022-09-30
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    Ropivacaine Hydrochloride

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    USDMF

    Caution USDMF

    36233
    Inactive
    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
    Inactive
    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

    Caution USDMF

    32260
    Inactive
    BELINOSTAT
    2018-01-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Belinostat IH at D-35, Industrial A...
    2019-07-08
    Application Number
    32260
    Indian CDSCO WC-0115
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-07-07
    Filing Details
    BELINOSTAT
    Belinostat IH at D-35, Industrial A...
    Issue/Submission Date
    2018-01-05
    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 at D-35, Industrial ...
    2022-09-30
    Application Number
    Indian CDSCO WC-0115A3
    Status
     
    Valid
    2025-09-15
    Filing Details
    Cabazitaxel IH at D-35, Industrial ...
    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

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

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2008-131 - Rev 04
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride
    Issue/Submission Date
    2022-02-11
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    Gemcitabine

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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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    Anastrozole

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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) at D-35, Indus...
    2019-07-08
    Application Number
    Indian CDSCO WC-0115
    Status
     
    Expired
    2022-07-07
    Filing Details
    Anastrozole (USP/IH) at D-35, Indus...
    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) at ...
    2019-07-08
    Application Number
    Indian CDSCO WC-0115
    Status
     
    Expired
    2022-07-07
    Filing Details
    Bendamustine Hydrochloride (IH) at ...
    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 at D-35, Industrial A...
    2019-07-08
    Application Number
    Indian CDSCO WC-0115
    Status
     
    Expired
    2022-07-07
    Filing Details
    Bortezomib IH at D-35, Industrial A...
    Issue/Submission Date
    2019-07-08
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    Buflomedil

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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
    Buflomedil Hydrochloride
    Issue/Submission Date
    2013-04-04
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    Cisplatin

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-281 - Rev 01
    Withdrawn by Holder
    Cisplatin
    2009-05-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-281 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Cisplatin
    Issue/Submission Date
    2009-05-15
    ASK
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    Indian CDSCO WC-0115
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    Decitabine (IH) at D-35, Industrial...
    2019-07-08
    Application Number
    Indian CDSCO WC-0115
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    Expired
    2022-07-07
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    Decitabine (IH) at D-35, Industrial...
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    2019-07-08
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    2019-07-08
    Application Number
    Indian CDSCO WC-0115
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    Expired
    2022-07-07
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    14395
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    1999-09-08
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    Application Number
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    METAXALONE
    Issue/Submission Date
    1999-09-08
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    2022-07-07
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    35027
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    RIBOCICLIB SUCCINATE
    2020-09-10
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    R1-CEP 2012-289 - Rev 00
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    2019-03-21
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    R1-CEP 2012-289 - Rev 00
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    33870
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    SUGAMMADEX SODIUM
    2019-06-14
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