Zhejiang Hengkang Mesalazine Zhejiang Hengkang Mesalazine

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    09410_FLUKA

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    Axplora

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    Mesalazine

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    Application Number
    8070
    219MF10036
    Indian CDSCO WC-0019
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    2025-05-28
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    5-AMINOSALICYLIC ACID (MESALAZINE/M...
    Mesalazine at ROSENHEIMER STR. 43 D...
    Mesalazine Ph. Eur & Mesalamine USP
    Issue/Submission Date
    1989-05-09
    2007-02-13
    2022-03-18
    Axplora CB

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    Axplora

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    Application Number
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    Mesalazine at Plot No. 115, Ramky P...
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    2014-03-11
    Axplora CB

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    Axplora

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    Application Number
    226MF10019
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    Mesalazine at ROSENHEIMER STR. 43 D...
    Issue/Submission Date
    2014-01-21
    Axplora CB

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    Jai Radhe Sales

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      Metrochem API Private Limited

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      Metrochem

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      DKSH

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      IOL Chemicals and Pharmaceuticals

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      Application Number
      38338
      Status
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      Fees Paid
      N/A
       
      Filing Details
      MESALAMINE USP
      Issue/Submission Date
      2023-10-14
      IOL Chemicals

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      Exhibiting

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      LGM Pharma

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      LGM Pharma CB

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      HRV Global Life Sciences

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        Zhejiang Hengkang Pharmaceutical

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        Application Number
        37319
        R1-CEP 2015-209 - Rev 00
        305MF10102
        ZJ220039
        Status
        Active
        Fees Unpaid
        Reviewed
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        Valid
        2024-12-15
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        MESALAMINE USP
        Mesalazine, HP
        Mesalazine at No. 11 Chengen Road, ...
        Mesalazine
        Issue/Submission Date
        2022-08-17
        2021-05-06
        2023-08-30
        2022-04-28
        Hengkang

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        Booth # 6X-25

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        Zhejiang Hengkang Pharmaceutical

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        Application Number
        R0-CEP 2021-400 - Rev 00
        227MF10271
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        Mesalazine, Pubagang site
        Mesalazine at No. 1 Longxiang Road,...
        Issue/Submission Date
        2021-12-17
        2015-12-01
        Hengkang

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        Chynops Pharma

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          Corden Pharma Bergamo S.p.A

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          Application Number
          11807
          R1-CEP 2003-243 - Rev 03
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          MESALAMINE
          Mesalazine
          Issue/Submission Date
          1996-01-15
          2018-03-29
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          Corden Pharma Bergamo S.p.A

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          Application Number
          19993
          R1-CEP 2006-300 - Rev 03
          Status
          Inactive
          Fees Paid
          N/A
          Withdrawn by Holder
           
          Filing Details
          MESALAMINE HIGH DENSITY
          Mesalazine, High density
          Issue/Submission Date
          2006-11-20
          2019-12-16
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          Alvogen

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          Application Number
          6576
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          ASACOL (5-AMINOSALICYLIC ACID) TABL...
          Issue/Submission Date
          1986-09-12
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          SIGMA TAU

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          Application Number
          5880
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          TOXICITY REPORTS FOR KOLLICOATS RS ...
          Issue/Submission Date
          1985-05-24
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          Solara Active Pharma Sciences

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          Application Number
          35717
          R0-CEP 2021-338 - Rev 00
          Status
          Active
          Fees Paid
          N/A
          Valid
           
          Filing Details
          MESALAMINE USP
          Mesalazine
          Issue/Submission Date
          2021-03-30
          2023-01-31
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          Ajinomoto OmniChem N.V.

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            Application Number
            7522
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            TERMINAL STERILIZATION PROGRAM IN G...
            Issue/Submission Date
            1988-06-06
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            INFAR S.A.

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            Application Number
            18742
            Status
            Active
            Fees Unpaid
            N/A
             
            Filing Details
            5-AMINOSALICYLIC ACID I (MESALAMINE...
            Issue/Submission Date
            2005-09-09
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            Dasami Lab

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              Application Number
              37413
              Status
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              Fees Unpaid
              Reviewed
               
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              MESALAMINE USP
              Issue/Submission Date
              2022-12-02
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              Lupin Ltd

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              Application Number
              21489
              Indian CDSCO WC-0201
              Status
              Active
              Fees Paid
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              2025-09-10
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              MESALAMINE USP
              Mesalamine (USP)
              Issue/Submission Date
              2008-03-28
              2022-09-30
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              Lupin Ltd

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              Application Number
              21514
              Indian CDSCO WC-0049
              Status
              Inactive
              Fees Paid
              N/A
               
              Valid
              2025-06-16
              Filing Details
              MESALAMINE USP
              Mesalamine (USP)
              Issue/Submission Date
              2008-03-28
              2022-06-07
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              Waitaki Biosciences

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                Application Number
                5219
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                5-AMINOSALICYLIC ACID
                Issue/Submission Date
                1983-12-23
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                SIMS Srl

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                Application Number
                18054
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                MESALAMINE
                Issue/Submission Date
                2005-02-02
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                Sun Pharmaceutical Industries Limit...

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                Application Number
                16431
                R1-CEP 2016-246 - Rev 00
                219MF10100
                Indian CDSCO WC-0159
                Status
                Inactive
                Fees Paid
                N/A
                Valid
                 
                Valid
                2025-07-25
                Filing Details
                MESALAMINE USP (5-AMINO SALICYLIC A...
                Mesalazine, Site II
                Mesalazine (production only) at SUN...
                Mesalamine/Mesalazine (USP/EP/BP)
                Issue/Submission Date
                2003-02-17
                2022-04-08
                2007-03-14
                2022-06-08
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                Sun Pharmaceutical Industries Limit...

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                Application Number
                24664
                R1-CEP 2003-267 - Rev 06
                Indian CDSCO WC-0412
                Status
                Inactive
                Fees Paid
                N/A
                Valid
                 
                Expired
                2023-08-29
                Filing Details
                MESALAMINE USP
                Mesalazine
                Mesalazine BP/EP/Mesalamine USP
                Issue/Submission Date
                2011-04-07
                2023-02-20
                2020-06-10
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                The Dow Chemical Company

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                Application Number
                6577
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                ASACOL TABLETS
                Issue/Submission Date
                1986-09-12
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                Ipca Laboratories

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                Mesalazine

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                USDMF

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                Application Number
                19261
                R1-CEP 2006-122 - Rev 04
                Indian CDSCO WC-0091
                Status
                Inactive
                Fees Paid
                N/A
                Valid
                 
                Valid
                2025-07-02
                Filing Details
                MESALAMINE USP
                Mesalazine
                Mesalamine/Mesalazine (BP/USP/ Ph.E...
                Issue/Submission Date
                2006-04-18
                2019-12-05
                2022-06-08
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                Ipca Laboratories

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                Application Number
                22617
                R0-CEP 2020-381 - Rev 00
                Status
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                Filing Details
                MESALAMINE USP (PROCESS II)
                Mesalazine, Mesalazine (MZ4B Proces...
                Issue/Submission Date
                2010-04-03
                2021-03-15
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                Ipca Laboratories

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                Application Number
                27245
                Status
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                Fees Paid
                N/A
                 
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                MESALAMINE USP (MZ3 PROCESS)
                Issue/Submission Date
                2013-07-25
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                Pliva Hrvatska

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                Application Number
                10645
                R1-CEP 2004-276 - Rev 01
                Status
                Inactive
                Fees Paid
                N/A
                Withdrawn by Holder
                 
                Filing Details
                MESALAZINE
                Mesalazine
                Issue/Submission Date
                1993-01-03
                2013-03-21
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                Cilag AG

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                Application Number
                6605
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                Filing Details
                MESALAZINE
                Issue/Submission Date
                1986-09-23
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                Wanbury Limited

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                Application Number
                31887
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                Fees Paid
                N/A
                 
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                MESALAMINE
                Issue/Submission Date
                2017-07-14
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                Eastman Chemical Company

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                Application Number
                6704
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                5-AMINOSALICYLIC ACID DOSAGE FORM F...
                Issue/Submission Date
                1986-12-03
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                Chemi SpA

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                Application Number
                9454
                R1-CEP 2008-046 - Rev 03
                219MF10131
                Status
                Inactive
                Fees Paid
                N/A
                Valid
                 
                Filing Details
                TERMINAL STERILZATION PROGRAM IN ME...
                Mesalazine, Product codes: FV0945, ...
                Mesalazine at Via dei Laboratori 54...
                Issue/Submission Date
                1991-12-09
                2020-03-17
                2007-04-18
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                Chemi SpA

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                Application Number
                11951
                R1-CEP 2003-188 - Rev 06
                Status
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                Filing Details
                MESALAMINE USP
                Mesalazine, Products codes: FV 0950...
                Issue/Submission Date
                1996-04-29
                2020-03-31
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                Teva API

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                Application Number
                11280
                Status
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                Fees Paid
                N/A
                 
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                MESALAZINE N
                Issue/Submission Date
                1995-01-04
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                BEC Chemicals Pvt. Ltd

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                Application Number
                36257
                R1-CEP 2011-100 - Rev 00
                Indian CDSCO WC-0061
                Status
                Active
                Fees Unpaid
                N/A
                Valid
                 
                Valid
                2025-07-21
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                MESALAMINE USP
                Mesalazine
                Mesalamine (USP/BP/EP)/Mesalazine (...
                Issue/Submission Date
                2023-02-24
                2017-06-29
                2022-06-07
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                Viatris

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                Application Number
                34374
                Status
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                Fees Paid
                N/A
                 
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                MESALAMINE USP
                Issue/Submission Date
                2019-12-05
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                Maithri Drugs

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                  Application Number
                  31570
                  R1-CEP 2017-116 - Rev 00
                  Indian CDSCO WC-0407
                  Status
                  Active
                  Fees Unpaid
                  N/A
                  Valid
                   
                  Expired
                  2023-06-28
                  Filing Details
                  MESALAMINE USP
                  Mesalazine
                  Mesalamine USP/EP
                  Issue/Submission Date
                  2017-03-31
                  2023-04-13
                  2020-09-09
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                  Divis Laboratories

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                  Application Number
                  29998
                  R1-CEP 2016-050 - Rev 01
                  231MF10004
                  Indian CDSCO WC-0030
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Expired
                  2022-06-16
                  Filing Details
                  MESALAMINE USP
                  Mesalazine
                  Mesalazine at 1-72/23(P)/DIVIS/303,...
                  Mesalamine (IP/USP/BP/Ph.Eur)
                  Issue/Submission Date
                  2015-11-06
                  2022-11-08
                  2019-01-10
                  2019-06-17
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                  Erregierre SpA

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                  Application Number
                  13883
                  R1-CEP 2004-049 - Rev 04
                  221MF10064
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Filing Details
                  MESALAMINE USP-EP
                  Mesalazine
                  Mesalazine at VIA F. BARACCA 19-240...
                  Issue/Submission Date
                  1998-12-03
                  2019-10-03
                  2009-03-26
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                  Erregierre SpA

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                  Application Number
                  24889
                  R1-CEP 2011-322 - Rev 00
                  219MF10065
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Filing Details
                  MESALAMINE USP - PH.EUR. (HIGH DENS...
                  Mesalazine, High density
                  Mesalazine at VIA F. BARACCA 19-240...
                  Issue/Submission Date
                  2011-04-26
                  2017-10-30
                  2007-03-05
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                  Signa S.A. de C.V.

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                  Application Number
                  29676
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  MESALAMINE USP
                  Issue/Submission Date
                  2016-01-12
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                  Institute Molecular biology

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                    Application Number
                    9562
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    SALOFALK 250MG MESALAMINE ENTERIC C...
                    Issue/Submission Date
                    1991-11-22
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                    RANBAXY LABORATORIES LIMITED

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                    Application Number
                    29575
                    Status
                    Active
                    Fees Paid
                    Reviewed
                     
                    Filing Details
                    MESALAMINE USP
                    Issue/Submission Date
                    2015-08-20
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                    Daiwa Chemical Industries

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                      Application Number
                      15982
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      5-ASA CRUDE (5-AMINOSALICYLIC ACID ...
                      Issue/Submission Date
                      2002-05-20
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                      Syntese AS

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                        Application Number
                        19618
                        CEP 2004-056 - Rev 06
                        Status
                        Active
                        Fees Unpaid
                        N/A
                        Valid
                         
                        Filing Details
                        MESALAMINE (5-AMINOSALICYLIC ACID) ...
                        Mesalazine
                        Issue/Submission Date
                        2006-07-21
                        2024-03-04
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                        CTX Lifesciences

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                        Application Number
                        29051
                        R1-CEP 2015-152 - Rev 00
                        Indian CDSCO WC-0097
                        Status
                        Active
                        Fees Paid
                        N/A
                        Valid
                         
                        Valid
                        2025-07-02
                        Filing Details
                        MESALAMINE USP
                        Mesalazine
                        Mesalamine USP/Mesalazine EP
                        Issue/Submission Date
                        2015-02-20
                        2021-06-09
                        2022-06-24
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                        Optimus Pharma

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                        Application Number
                        35136
                        Status
                        Active
                        Fees Paid
                        Reviewed
                         
                        Filing Details
                        MESALAMINE
                        Issue/Submission Date
                        2020-12-28
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                        • ENEMA;RECTAL - 4GM/60ML
                        • CAPSULE, EXTENDED RELEASE;ORAL - 250MG
                        • CAPSULE, EXTENDED RELEASE;ORAL - 500MG
                        • CAPSULE, DELAYED RELEASE;ORAL - 400MG
                        • SUPPOSITORY;RECTAL - 1GM
                        • TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
                        • TABLET, DELAYED RELEASE;ORAL - 1.2GM
                        • CAPSULE, EXTENDED RELEASE;ORAL - 375MG

                        Looking for 89-57-6 / Mesalazine API manufacturers, exporters & distributors?

                        Mesalazine manufacturers, exporters & distributors 1

                        42

                        PharmaCompass offers a list of Mesalazine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mesalazine manufacturer or Mesalazine supplier for your needs.

                        Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mesalazine manufacturer or Mesalazine supplier.

                        PharmaCompass also assists you with knowing the Mesalazine API Price utilized in the formulation of products. Mesalazine API Price is not always fixed or binding as the Mesalazine Price is obtained through a variety of data sources. The Mesalazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

                        API | Excipient name

                        Mesalazine

                        Synonyms

                        5-aminosalicylic acid, 89-57-6, 5-amino-2-hydroxybenzoic acid, Asacol, Pentasa, Canasa

                        Cas Number

                        89-57-6

                        Unique Ingredient Identifier (UNII)

                        4Q81I59GXC

                        About Mesalazine

                        An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)

                        09410_FLUKA Manufacturers

                        A 09410_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 09410_FLUKA, including repackagers and relabelers. The FDA regulates 09410_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 09410_FLUKA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

                        click here to find a list of 09410_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

                        09410_FLUKA Suppliers

                        A 09410_FLUKA supplier is an individual or a company that provides 09410_FLUKA active pharmaceutical ingredient (API) or 09410_FLUKA finished formulations upon request. The 09410_FLUKA suppliers may include 09410_FLUKA API manufacturers, exporters, distributors and traders.

                        click here to find a list of 09410_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

                        09410_FLUKA Manufacturers | Traders | Suppliers

                        09410_FLUKA Manufacturers, Traders, Suppliers 1
                        75

                        We have 73 companies offering 09410_FLUKA

                        Get in contact with the supplier of your choice:

                        1. Jai Radhe Sales
                        2. Metrochem API Private Limited
                        3. DKSH
                        4. IOL Chemicals and Pharmaceuticals
                        5. Axplora
                        6. LGM Pharma
                        7. HRV Global Life Sciences
                        8. Zhejiang Hengkang Pharmaceutical
                        9. Chynops Pharma
                        10. A.H.A International
                        11. Ajinomoto Company
                        12. Ajinomoto OmniChem N.V.
                        13. Alkem Laboratories
                        14. ALP Pharm
                        15. Alvogen
                        16. Amoli Organics
                        17. Aspire Lifesciences Pvt Ltd
                        18. Aurobindo Pharma Limited
                        19. Aurore Life Sciences
                        20. Bayer AG
                        21. BEC Chemicals Pvt. Ltd
                        22. Cambrex Corporation
                        23. Chemi SpA
                        24. Cilag AG
                        25. Corden Pharma Bergamo S.p.A
                        26. Credo Life Sciences
                        27. CTX Lifesciences
                        28. Daiwa Chemical Industries
                        29. Dasami Lab
                        30. DEAFARMA
                        31. Divis Laboratories
                        32. DK Pharmachem Pvt. Ltd
                        33. Eastman Chemical Company
                        34. Erregierre SpA
                        35. Ferring Pharmaceuticals
                        36. Guangzhou Tosun Pharmaceutical
                        37. Hasti Aria Shimi
                        38. Hetero Drugs
                        39. Hy-Gro Chemicals Pharmtek
                        40. INFAR S.A.
                        41. Institute Molecular biology
                        42. Ipca Laboratories
                        43. Jiangsu Jubang Pharmaceutical
                        44. Kimyagaran
                        45. Lupin Ltd
                        46. Maithri Drugs
                        47. MERCK & CIE
                        48. Murli Krishna Pharma
                        49. Oceanic Laboratories
                        50. Optimus Pharma
                        51. Osmopharm
                        52. Pliva Hrvatska
                        53. Qualitek pharma
                        54. RA CHEM PHARMA LIMITED
                        55. RANBAXY LABORATORIES LIMITED
                        56. Refarmed Chemicals
                        57. Senores Pharmaceuticals
                        58. SIGMA TAU
                        59. Signa S.A. de C.V.
                        60. SIMS Srl
                        61. Sms Lifesciences
                        62. Solara Active Pharma Sciences
                        63. Sun Pharmaceutical Industries Limited
                        64. Syntese AS
                        65. Teva API
                        66. The Dow Chemical Company
                        67. Unipex
                        68. Vaishali Pharma Ltd
                        69. Viatris
                        70. Waitaki Biosciences
                        71. Wanbury Limited
                        72. Zim Laboratories
                        73. Zydus Lifesciences
                        Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
                        For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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