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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Fresenius SE & Co. KGaA by EDQM. Original Data: EDQM Database

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    Fresenius SE & Co. KGaA
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    Else-Kröner-Str. 1 61352 Bad Homburg
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    Amoxicillin sodium

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    FRESENIUS KABI IPSUM S....
    Valid
    R1-CEP 2008-267 - Rev 07
    Chemical
    2022-10-11
    577
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      Ampicillin sodium

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      FRESENIUS KABI IPSUM S....
      Valid
      CEP 2012-224 - Rev 05
      Chemical
      2024-02-20
      578
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      Ampicillin sodium, Sterile

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      FRESENIUS KABI IPSUM S....
      Valid
      R1-CEP 2007-227 - Rev 04
      Chemical
      2021-02-11
      578
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      Bacampicillin Hydrochloride

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      FRESENIUS KABI IPSUM S....
      Valid
      R1-CEP 2004-188 - Rev 06
      Chemical
      2022-10-10
      808
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      Bicalutamide

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      FRESENIUS KABI ONCOLOGY...
      Valid
      R1-CEP 2012-369 - Rev 00
      Chemical
      2021-05-20
      2196
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      Buflomedil Hydrochloride

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      FRESENIUS KABI ONCOLOGY...
      Withdrawn by Holder
      R0-CEP 2010-346 - Rev 00
      Chemical
      2013-04-04
      2015-11-24
      1398
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      Busulfan

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      FRESENIUS KABI ONCOLOGY...
      Valid
      CEP 2010-374 - Rev 07
      Chemical
      2023-10-13
      542
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      Carboplatin

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      FRESENIUS KABI ONCOLOGY...
      Valid
      R1-CEP 2001-282 - Rev 13
      Chemical
      2022-03-07
      1081
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      Cefalotin sodium, Sterile

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      FRESENIUS KABI IPSUM S....
      Withdrawn by Holder
      R1-CEP 2004-227 - Rev 03
      Chemical
      2019-04-24
      2022-01-14
      987
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      Cefatrizine propylene glycol

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      FRESENIUS KABI IPSUM S....
      Withdrawn by Holder
      R1-CEP 1999-142 - Rev 05
      Chemical
      2019-04-24
      2022-02-09
      1403
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      • FDA
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      Cefazolin sodium, Sterile, process A

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      FRESENIUS KABI IPSUM S....
      Withdrawn by Holder
      R1-CEP 2003-158 - Rev 04
      Chemical
      2017-09-15
      2018-07-17
      988
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        Cefazolin sodium, sterile, process B

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        FRESENIUS KABI Anti-Inf...
        Withdrawn by Holder
        R1-CEP 1998-092 - Rev 05
        Chemical
        2010-11-08
        2013-06-13
        988
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          Cefepime dihydrochloride monohydrate, Sterile

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          FRESENIUS KABI IPSUM S....
          Valid
          R1-CEP 2007-205 - Rev 06
          Chemical
          2022-11-07
          2126
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            Cefepime dihydrochloride monohydrate, Sterile, process ...

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            FRESENIUS KABI IPSUM S....
            Valid
            CEP 2022-460 - Rev 00
            Chemical
            2023-09-13
            2126
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              Cefoperazone sodium, Sterile

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              FRESENIUS KABI IPSUM S....
              Withdrawn by Holder
              R1-CEP 2003-277 - Rev 04
              Chemical
              2021-02-10
              2023-02-13
              1404
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                Cefotaxime sodium, Sterile

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                FRESENIUS KABI IPSUM S....
                Valid
                R1-CEP 1999-056 - Rev 07
                Chemical
                2021-02-10
                989
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                  Cefoxitin sodium, Sterile

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                  FRESENIUS KABI Anti-Inf...
                  Expired
                  R0-CEP 2007-173 - Rev 01
                  Chemical
                  2013-04-24
                  2015-12-18
                  990
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                    Ceftazidime pentahydrate with sodium carbonate for inje...

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                    FRESENIUS KABI IPSUM S....
                    Valid
                    R0-CEP 2018-008 - Rev 01
                    Chemical
                    2021-02-11
                    2344
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                      Ceftazidime Pentahydrate, Sterile

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                      FRESENIUS KABI IPSUM S....
                      Valid
                      R1-CEP 2004-129 - Rev 07
                      Chemical
                      2023-05-26
                      1405
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                        Ceftriaxone sodium

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                        FRESENIUS KABI IPSUM S....
                        Valid
                        R1-CEP 2010-232 - Rev 04
                        Chemical
                        2021-08-27
                        991
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                          Ceftriaxone sodium, Sterile

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                          Ribbon S.r.l. Milano IT
                          Expired
                          R0-CEP 2003-214 - Rev 00
                          Chemical
                          2005-01-26
                          2010-01-26
                          991
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                            Ceftriaxone sodium, Sterile

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                            FRESENIUS KABI IPSUM S....
                            Valid
                            R1-CEP 2004-119 - Rev 08
                            Chemical
                            2021-02-10
                            991
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                              Cefuroxime sodium, Sterile

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                              FRESENIUS KABI IPSUM S....
                              Valid
                              R1-CEP 1997-044 - Rev 11
                              Chemical
                              2021-12-17
                              992
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                              Cisplatin

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                              FRESENIUS KABI ONCOLOGY...
                              Withdrawn by Holder
                              R1-CEP 2001-281 - Rev 01
                              Chemical
                              2009-05-15
                              2016-08-10
                              599
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                                Cloxacillin sodium, Powder and compacted

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                                FRESENIUS KABI IPSUM S....
                                Valid
                                R1-CEP 1996-091 - Rev 08
                                Chemical
                                2021-02-10
                                661
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                                Cloxacillin sodium, Sterile

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                                FRESENIUS KABI IPSUM S....
                                Valid
                                R1-CEP 1998-025 - Rev 08
                                Chemical
                                2021-06-10
                                661
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                                  Dicloxacillin sodium, Powder and compacted

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                                  FRESENIUS KABI IPSUM S....
                                  Valid
                                  R1-CEP 2002-036 - Rev 07
                                  Chemical
                                  2021-08-16
                                  663
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                                    Dicloxacillin sodium, sterile

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                                    Ribbon S.r.l. Milano IT
                                    Withdrawn by Holder
                                    R1-CEP 1996-092 - Rev 00
                                    Chemical
                                    2002-02-18
                                    2003-06-12
                                    663
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                                    Docetaxel

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                                    FRESENIUS KABI ONCOLOGY...
                                    Valid
                                    CEP 2012-293 - Rev 02
                                    Chemical
                                    2023-11-17
                                    2593
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                                    Docetaxel trihydrate

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                                    FRESENIUS KABI ONCOLOGY...
                                    Valid
                                    R1-CEP 2011-189 - Rev 04
                                    Chemical
                                    2023-02-16
                                    2449
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                                      Flucloxacillin sodium monohydrate, Powder and compacted

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                                      FRESENIUS KABI IPSUM S....
                                      Valid
                                      R1-CEP 1996-054 - Rev 10
                                      Chemical
                                      2022-05-17
                                      668
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                                        Flucloxacillin sodium monohydrate, Sterile

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                                        FRESENIUS KABI IPSUM S....
                                        Valid
                                        R1-CEP 1996-093 - Rev 06
                                        Chemical
                                        2022-05-20
                                        668
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                                        Gemcitabine hydrochloride

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                                        FRESENIUS KABI ONCOLOGY...
                                        Valid
                                        R1-CEP 2008-131 - Rev 04
                                        Chemical
                                        2022-02-11
                                        2306
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                                        Gemcitabine hydrochloride, Alternate process

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                                        FRESENIUS KABI ONCOLOGY...
                                        Valid
                                        R1-CEP 2012-080 - Rev 01
                                        Chemical
                                        2019-10-08
                                        2306
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                                        Gemcitabine hydrochloride, Alternate Process-2

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                                        FRESENIUS KABI ONCOLOGY...
                                        Valid
                                        CEP 2023-271 - Rev 00
                                        Chemical
                                        2023-12-06
                                        2306
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                                        Irinotecan hydrochloride trihydrate

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                                        FRESENIUS KABI ONCOLOGY...
                                        Valid
                                        R0-CEP 2017-234 - Rev 02
                                        Chemical
                                        2022-09-02
                                        2675
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                                          Lactulose

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                                          Fresenius Kabi Austria ...
                                          Valid
                                          R1-CEP 2002-236 - Rev 03
                                          Chemical
                                          2017-10-11
                                          1230
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                                            Lactulose, liquid

                                            PDF Supplier PDF
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                                            Fresenius Kabi Austria ...
                                            Valid
                                            R1-CEP 2005-023 - Rev 02
                                            Chemical
                                            2017-09-07
                                            924
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                                              Lactulose, liquid, 667 g/L

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                                              Fresenius Kabi Austria ...
                                              Valid
                                              R0-CEP 2019-138 - Rev 00
                                              Chemical
                                              2019-11-15
                                              924
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                                                Lactulose, liquid, 670 g/l

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                                                Fresenius Kabi Austria ...
                                                Valid
                                                R1-CEP 1998-130 - Rev 03
                                                Chemical
                                                2007-11-30
                                                924
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                                                  Lactulose, liquid, with sodium benzoate

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                                                  Fresenius Kabi Austria ...
                                                  Valid
                                                  R1-CEP 2015-187 - Rev 00
                                                  Chemical
                                                  2020-10-30
                                                  924
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                                                  Letrozole

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                                                  FRESENIUS KABI ONCOLOGY...
                                                  Valid
                                                  R1-CEP 2007-338 - Rev 03
                                                  Chemical
                                                  2023-01-09
                                                  2334
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                                                  Oxaliplatin

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                                                  FRESENIUS KABI ONCOLOGY...
                                                  Valid
                                                  R1-CEP 2007-193 - Rev 05
                                                  Chemical
                                                  2021-09-24
                                                  2017
                                                  ASK
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                                                  Paclitaxel, Semi-synthetic process

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                                                  FRESENIUS KABI ONCOLOGY...
                                                  Valid
                                                  R1-CEP 2008-181 - Rev 10
                                                  Chemical
                                                  2022-10-17
                                                  1794
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                                                    Piperacillin monohydrate

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                                                    FRESENIUS KABI IPSUM S....
                                                    Valid
                                                    R1-CEP 2012-101 - Rev 03
                                                    Chemical
                                                    2023-03-20
                                                    1169
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                                                      Piperacillin sodium, Sterile

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                                                      FRESENIUS KABI IPSUM S....
                                                      Withdrawn by Holder
                                                      R1-CEP 1998-123 - Rev 14
                                                      Chemical
                                                      2023-01-18
                                                      2023-12-06
                                                      1168
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                                                        Pivmecillinam hydrochloride

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                                                        FRESENIUS KABI IPSUM S....
                                                        Valid
                                                        R1-CEP 2004-262 - Rev 06
                                                        Chemical
                                                        2023-02-01
                                                        1359
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                                                        Ropivacaine hydrochloride monohydrate

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                                                        FRESENIUS KABI ONCOLOGY...
                                                        Withdrawn by Holder
                                                        R1-CEP 2012-289 - Rev 00
                                                        Chemical
                                                        2019-03-21
                                                        2024-03-06
                                                        2335
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                                                        Ropivacaine hydrochloride monohydrate, Alternate proces...

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                                                        FRESENIUS KABI ONCOLOGY...
                                                        Valid
                                                        R0-CEP 2021-130 - Rev 00
                                                        Chemical
                                                        2021-09-14
                                                        2335
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                                                          Starches, hydroxyethyl, Mw 200, MS 0.5, C2/C6 6

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                                                          Fresenius Kabi Austria ...
                                                          Valid
                                                          R1-CEP 2010-242 - Rev 00
                                                          Chemical
                                                          2017-06-29
                                                          1785
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