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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Gedeon Richter by EDQM. Original Data: EDQM Database

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    Gedeon Richter

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    APIs // Active Pharmaceutical Ingredients

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    01 Amlodipine besilate (1)

    02 Amlodipine besilate, RTML process (1)

    03 Cimetidine, Crystallised from ethanol (1)

    04 Cimetidine, Crystallized from isopropanol (1)

    05 Desogestrel (1)

    06 Dienogest, Micronised (1)

    07 Drospirenone (1)

    08 Drospirenone, Process 2 (1)

    09 Drospirenone, Process 2 micronized (1)

    10 Drospirenone, Process I (1)

    11 Enalapril maleate (1)

    12 Estradiol hemihydrate (1)

    13 Ethinylestradiol (1)

    14 Famotidine (1)

    15 Fluconazole (1)

    16 Fluoxetine hydrochloride (1)

    17 Flutamide (1)

    18 Gestodene, Crystallised (1)

    19 Gestodene, Micronised (1)

    20 Levonorgestrel (1)

    21 Lisinopril dihydrate (1)

    22 Norethisterone acetate (1)

    23 Norgestimate (1)

    24 Ondansetron hydrochloride dihydrate (1)

    25 Paroxetine hydrochloride hemihydrate (1)

    26 Sodium alendronate trihydrate, Milled (1)

    27 Spironolactone, Micronised (1)

    28 Terbinafine hydrochloride (1)

    29 Vinblastine Sulfate (1)

    30 Vinblastine Sulfate, New Process (1)

    31 Vincristine sulfate (1)

    32 Vinpocetine (1)

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    01 GEDEON RICHTER PLC Budapest HU (30)

    02 Gedeon Richter Ltd Budapest HU (2)

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    01 Hungary (32)

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    01 Expired (2)

    02 Valid (25)

    03 Withdrawn by Holder (5)

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      Amlodipine besilate

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      GEDEON RICHTER PLC Buda...
      Valid
      R1-CEP 2001-322 - Rev 03
      Chemical
      2022-03-23
      1491
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        Amlodipine besilate, RTML process

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        GEDEON RICHTER PLC Buda...
        Valid
        R1-CEP 2010-318 - Rev 01
        Chemical
        2022-08-18
        1491
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          Cimetidine, Crystallised from ethanol

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          Gedeon Richter Ltd Buda...
          Expired
          R0-CEP 2000-153 - Rev 01
          Chemical
          2004-11-09
          2007-08-01
          756
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            Cimetidine, Crystallized from isopropanol

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            Gedeon Richter Ltd Buda...
            Expired
            R0-CEP 2001-371 - Rev 01
            Chemical
            2004-11-09
            2007-11-22
            756
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              Desogestrel

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              GEDEON RICHTER PLC Buda...
              Valid
              R1-CEP 2006-174 - Rev 04
              Chemical
              2022-02-18
              1717
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                Dienogest, Micronised

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                GEDEON RICHTER PLC Buda...
                Valid
                R0-CEP 2020-023 - Rev 00
                Chemical
                2022-05-03
                2732
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                  Drospirenone

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                  GEDEON RICHTER PLC Buda...
                  Valid
                  R1-CEP 2009-402 - Rev 00
                  Chemical and TSE
                  2015-06-08
                  2404
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                    Drospirenone, Process 2

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                    GEDEON RICHTER PLC Buda...
                    Valid
                    R0-CEP 2022-278 - Rev 01
                    Chemical
                    2023-07-31
                    2404
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                      Drospirenone, Process 2 micronized

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                      GEDEON RICHTER PLC Buda...
                      Valid
                      R0-CEP 2022-279 - Rev 00
                      Chemical
                      2022-12-01
                      2404
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                        Drospirenone, Process I

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                        GEDEON RICHTER PLC Buda...
                        Valid
                        R0-CEP 2021-508 - Rev 00
                        Chemical and TSE
                        2022-05-30
                        2404
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