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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Grace

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    Grace
    United_States_of_America Flag
    Country
    Country
    U.S.A
    Address
    Address
    7500 Grace Drive Columbia, MD 21044
    Telephone
    Telephone
    +1 410.531.4000
    Client Email
    Email
    enquiries@pharmacompass.com
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    Website
    http://www.grace.com/finechemicals
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    https://www.linkedin.com/company/wr-grace/
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      Itraconazole

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      USDMF

      Found USDMF

      12697
      Active
      ITRACONAZOLE USP & PH EUR
      1997-10-16
      CEP/COS

      Found CEP/COS

      R1-CEP 1999-196 - Rev 04
      Valid
      Itraconazole
      2021-07-29
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      12697
      R1-CEP 1999-196 - Rev 04
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Filing Details
      ITRACONAZOLE USP & PH EUR
      Itraconazole
      Issue/Submission Date
      1997-10-16
      2021-07-29
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        Amifostine

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        USDMF

        Found USDMF

        22909
        Active
        AMIFOSTINE
        2009-06-26
        CEP/COS

        Close CEP/COS

        Japanese DMF

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        Written Confirmation

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        Application Number
        22909
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        AMIFOSTINE
        Issue/Submission Date
        2009-06-26
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          Benazepril Hydrochloride

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          USDMF

          Found USDMF

          14720
          Active
          BENAZEPRIL HYDROCHLORIDE
          2000-02-21
          CEP/COS

          Close CEP/COS

          Japanese DMF

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          Written Confirmation

          Close WC

          Application Number
          14720
          Status
          Active
          Fees Unpaid
          Reviewed
           
          Filing Details
          BENAZEPRIL HYDROCHLORIDE
          Issue/Submission Date
          2000-02-21
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            Benzonatate

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            USDMF

            Found USDMF

            5196
            Active
            BENZONATATE USP
            1983-12-13
            CEP/COS

            Close CEP/COS

            Japanese DMF

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            Written Confirmation

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            Application Number
            5196
            Status
            Active
            Fees Unpaid
            Reviewed
             
            Filing Details
            BENZONATATE USP
            Issue/Submission Date
            1983-12-13
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              Diphenhydramine Citrate

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              USDMF

              Found USDMF

              11097
              Active
              DIPHENHYDRAMINE CITRATE, USP
              1994-09-23
              CEP/COS

              Close CEP/COS

              Japanese DMF

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              Written Confirmation

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              Application Number
              11097
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              DIPHENHYDRAMINE CITRATE, USP
              Issue/Submission Date
              1994-09-23
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                Fenoprofen Calcium

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                USDMF

                Found USDMF

                6843
                Active
                FENOPROFEN CALCIUM, USP+BP
                1987-03-03
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

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                Application Number
                6843
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Filing Details
                FENOPROFEN CALCIUM, USP+BP
                Issue/Submission Date
                1987-03-03
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                  Flurbiprofen

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                  USDMF

                  Found USDMF

                  11902
                  Active
                  FLURBIPROFEN USP & BP
                  1996-03-26
                  CEP/COS

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                  Japanese DMF

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                  Written Confirmation

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                  Application Number
                  11902
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                   
                  Filing Details
                  FLURBIPROFEN USP & BP
                  Issue/Submission Date
                  1996-03-26
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                    Lidocaine

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                    USDMF

                    Found USDMF

                    4323
                    Active
                    LIDOCAINE HCL, USP, BP & PH EUR
                    1981-11-10
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    4323
                    Status
                    Active
                    Fees Unpaid
                    Reviewed
                     
                    Filing Details
                    LIDOCAINE HCL, USP, BP & PH EUR
                    Issue/Submission Date
                    1981-11-10
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                      Lidocaine

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                      USDMF

                      Found USDMF

                      11564
                      Active
                      LIDOCAINE USP
                      1995-06-05
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      11564
                      Status
                      Active
                      Fees Unpaid
                      Reviewed
                       
                      Filing Details
                      LIDOCAINE USP
                      Issue/Submission Date
                      1995-06-05
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                        Lidocaine Hydrochloride

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                        USDMF

                        Close USDMF

                        CEP/COS

                        Found CEP/COS

                        R1-CEP 2010-029 - Rev 02
                        Valid
                        Lidocaine hydrochloride monohydrate
                        2021-08-02
                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        R1-CEP 2010-029 - Rev 02
                        Status
                        Valid
                         
                        Filing Details
                        Lidocaine hydrochloride monohydrate
                        Issue/Submission Date
                        2021-08-02
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                          Meclofenamic Acid

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                          USDMF

                          Found USDMF

                          5584
                          Active
                          MECLOFENAMATE SODIUM USP
                          1984-11-13
                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          5584
                          Status
                          Active
                          Fees Unpaid
                          Reviewed
                           
                          Filing Details
                          MECLOFENAMATE SODIUM USP
                          Issue/Submission Date
                          1984-11-13
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                            Milrinone

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                            USDMF

                            Found USDMF

                            14375
                            Active
                            MILRINONE USP
                            1999-08-31
                            CEP/COS

                            Close CEP/COS

                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            14375
                            Status
                            Active
                            Fees Unpaid
                            Reviewed
                             
                            Filing Details
                            MILRINONE USP
                            Issue/Submission Date
                            1999-08-31
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                              Orphenadrine

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                              USDMF

                              Found USDMF

                              5722
                              Active
                              ORPHENADRINE CITRATE USP
                              1985-02-22
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              5722
                              Status
                              Active
                              Fees Unpaid
                              Reviewed
                               
                              Filing Details
                              ORPHENADRINE CITRATE USP
                              Issue/Submission Date
                              1985-02-22
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                                Pramoxine Hydrochloride

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                                USDMF

                                Found USDMF

                                13230
                                Active
                                PRAMOXINE HYDROCHLORIDE
                                1998-09-24
                                CEP/COS

                                Close CEP/COS

                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                13230
                                Status
                                Active
                                Fees Unpaid
                                Reviewed
                                 
                                Filing Details
                                PRAMOXINE HYDROCHLORIDE
                                Issue/Submission Date
                                1998-09-24
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                                  Procainamide Hydrochloride

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                                  USDMF

                                  Found USDMF

                                  4911
                                  Active
                                  PROCAINAMIDE HYDROCHLORIDE
                                  1983-04-18
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  4911
                                  Status
                                  Active
                                  Fees Unpaid
                                  Reviewed
                                   
                                  Filing Details
                                  PROCAINAMIDE HYDROCHLORIDE
                                  Issue/Submission Date
                                  1983-04-18
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                                    Propranolol Hydrochloride

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                                    USDMF

                                    Found USDMF

                                    5861
                                    Active
                                    PROPRANOLOL HYDROCHLORIDE
                                    1985-06-05
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    5861
                                    Status
                                    Active
                                    Fees Unpaid
                                    Reviewed
                                     
                                    Filing Details
                                    PROPRANOLOL HYDROCHLORIDE
                                    Issue/Submission Date
                                    1985-06-05
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                                      Terconazole

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                                      USDMF

                                      Found USDMF

                                      12887
                                      Active
                                      TERCONAZOLE
                                      1998-02-19
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      12887
                                      Status
                                      Active
                                      Fees Unpaid
                                      Reviewed
                                       
                                      Filing Details
                                      TERCONAZOLE
                                      Issue/Submission Date
                                      1998-02-19
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                                        Tetracaine Hydrochloride

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                                        USDMF

                                        Found USDMF

                                        8221
                                        Active
                                        TETRACAINE HCL
                                        1989-09-21
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        8221
                                        Status
                                        Active
                                        Fees Unpaid
                                        Reviewed
                                         
                                        Filing Details
                                        TETRACAINE HCL
                                        Issue/Submission Date
                                        1989-09-21
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                                          Aminohippuric Acid

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                                          USDMF

                                          Caution USDMF

                                          4505
                                          Inactive
                                          PARA-AMINOHIPPURIC ACID USP XX
                                          1982-04-26
                                          CEP/COS

                                          Close CEP/COS

                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          4505
                                          Status
                                          Inactive
                                          Fees Unpaid
                                          N/A
                                           
                                          Filing Details
                                          PARA-AMINOHIPPURIC ACID USP XX
                                          Issue/Submission Date
                                          1982-04-26
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                                            CAS 150975-95-4

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                                            USDMF

                                            Caution USDMF

                                            10812
                                            Inactive
                                            MACA (5-METHANESULFONYLAMINOINDOLE-...
                                            1994-03-15
                                            CEP/COS

                                            Close CEP/COS

                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            10812
                                            Status
                                            Inactive
                                            Fees Unpaid
                                            N/A
                                             
                                            Filing Details
                                            MACA (5-METHANESULFONYLAMINOINDOLE-...
                                            Issue/Submission Date
                                            1994-03-15
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                                              Linezolid

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                                              USDMF

                                              Caution USDMF

                                              14091
                                              Inactive
                                              1LZD-LINEZOLID, STEP 1
                                              1999-04-22
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              14091
                                              Status
                                              Inactive
                                              Fees Unpaid
                                              N/A
                                               
                                              Filing Details
                                              1LZD-LINEZOLID, STEP 1
                                              Issue/Submission Date
                                              1999-04-22
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