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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by CHEMO IBERICA SA to the U.S. FDA. Original Data : FDA Website

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    CHEMO IBERICA SA
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    Country
    Country
    Spain
    Address
    Address
    Calle Quintanapalla, 2, 28050 Madrid
    Telephone
    Telephone
    + 34 91 302 15 60
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    enquiries@pharmacompass.com
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    http://www.chemogroup.com
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      ALISKIREN HEMIFUMARATE

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      CHEMO IBERICA SA
      Inactive
      26776
      N/A
      2012-12-27
      II
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        ASENAPINE MALEATE

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        CHEMO IBERICA SA
        Inactive
        27290
        N/A
        2013-07-08
        II
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          ISRADIPINE

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          QUIMICA SINTETICA SA
          Active
          17367
          Complete
          2014-10-10
          2014-03-20
          2004-05-05
          II
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            LANSOPRAZOLE (PROCESS II)

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            QUIMICA SINTETICA SA
            Active
            29462
            Complete
            2016-03-08
            2015-08-07
            2015-06-26
            II
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              LANSOPRAZOLE USP

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              QUIMICA SINTETICA SA
              Active
              24487
              Complete
              2014-01-17
              2013-09-27
              2010-12-23
              II
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                LEVOFLOXACIN

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                QUIMICA SINTETICA SA
                Active
                28920
                Complete
                2015-06-01
                2015-03-16
                2014-12-15
                II
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                  Nedocromil Disodium

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                  CHEMO IBERICA SA MADR...
                  Inactive
                  21169
                  N/A
                  2007-12-19
                  II
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                    NINTEDANIB ESYLATE

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                    CHEMO IBERICA SA
                    Active
                    39158
                    N/A
                    2023-11-22
                    II
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                      PIRFENIDONE

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                      CHEMO IBERICA SA
                      Active
                      32796
                      Complete
                      2018-10-04
                      2018-05-31
                      2018-05-18
                      II
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                        RABEPRAZOLE SODIUM (PROCESS I)

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                        CHEMO IBERICA SA MADR...
                        Inactive
                        21585
                        N/A
                        2008-04-30
                        II
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                          RABEPRAZOLE SODIUM (PROCESS II)

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                          QUIMICA SINTETICA SA
                          Active
                          25309
                          Complete
                          2014-01-06
                          2013-02-14
                          2011-09-20
                          II
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                            RANOLAZINE

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                            CHEMO SMS ENTERPRISE ...
                            Active
                            32133
                            Complete
                            2018-01-05
                            2017-11-27
                            2017-10-13
                            II
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                              SEVELAMER CARBONATE

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                              CHEMO IBERICA SA MADR...
                              Inactive
                              22262
                              N/A
                              2008-12-03
                              II
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                                SEVELAMER CARBONATE

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                                CHEMO IBERICA SA
                                Inactive
                                23388
                                N/A
                                2009-12-18
                                II
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                                  SEVELAMER HYDROCHLORIDE

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                                  CHEMO IBERICA SA
                                  Inactive
                                  22349
                                  N/A
                                  2008-12-23
                                  II
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                                    TAMSULOSIN HYDROCHLORIDE

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                                    QUIMICA SINTETICA SA
                                    Active
                                    21041
                                    Complete
                                    2020-12-07
                                    2020-11-25
                                    2007-11-16
                                    II
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                                      TIANEPTINE SODIUM

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                                      QUIMICA SINTETICA SA
                                      Active
                                      22308
                                      N/A
                                      2008-12-12
                                      II
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