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    Esomeprazole

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    Minakem

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    Application Number
    28462
    R1-CEP 2012-256 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    Esomeprazole magnesium trihydrate, ...
    Issue/Submission Date
    2014-07-08
    2021-06-03
    Minakem Comapny Banner

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    Minakem

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    Application Number
    34026
    R1-CEP 2015-086 - Rev 00
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    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE MI...
    Esomeprazole magnesium dihydrate, M...
    Issue/Submission Date
    2019-10-04
    2020-08-31
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    Tenatra Chemie

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    Temad Co

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    Rochem International Inc

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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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    Rochem

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    Jai Radhe Sales

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      Metrochem API Private Limited

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      Application Number
      35400
      R0-CEP 2021-022 - Rev 00
      Indian CDSCO WC-0493A3
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Expired
      2024-01-21
      Filing Details
      ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
      Esomeprazole magnesium dihydrate
      Esomeprazole Magnesium USP/Esomepra...
      Issue/Submission Date
      2020-11-28
      2022-05-19
      2021-12-17
      Metrochem

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      Metrochem API Private Limited

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      Application Number
      35519
      R0-CEP 2020-386 - Rev 00
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      ESOMEPRAZOLE MAGNESIUM DIHYDRATE
      Esomeprazole magnesium trihydrate
      Issue/Submission Date
      2020-12-29
      2022-05-24
      Metrochem

      CPhI North America

      Booth #1313

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      Dr. Reddy's Laboratories

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      Application Number
      23994
      R1-CEP 2012-395 - Rev 01
      Indian CDSCO WC-0067A4-5
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Valid
      2025-07-07
      Filing Details
      ESOMEPRAZOLE MAGNESIUM AMORPHOUS (P...
      Esomeprazole magnesium trihydrate
      Esomeprazole Magnesium/Esomeprazole...
      Issue/Submission Date
      2010-07-26
      2023-06-05
      2022-07-04
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      Dr. Reddy's Laboratories

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      Application Number
      25858
      R0-CEP 2023-070 - Rev 00
      Indian CDSCO WC-0067n
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Valid
      2025-07-07
      Filing Details
      ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
      Esomeprazole magnesium trihydrate, ...
      Esomeprazole Magnesium USP
      Issue/Submission Date
      2012-03-30
      2023-06-15
      2022-06-17
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      Dr. Reddy's Laboratories

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      Application Number
      28127
      R0-CEP 2021-243 - Rev 00
      Indian CDSCO WC-0067A3-A4
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Valid
      2025-07-07
      Filing Details
      ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
      Esomeprazole magnesium trihydrate, ...
      Esomeprazole Magnesium Trihydrate E...
      Issue/Submission Date
      2014-03-31
      2022-01-03
      2022-06-13
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      Dr. Reddy's Laboratories

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      Application Number
      Indian CDSCO WC-0035A3
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      Valid
      2025-06-25
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      Esomeprazole Magnesium IH
      Issue/Submission Date
      2022-06-15
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      Dr. Reddy's Laboratories

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      Application Number
      Indian CDSCO WC-0035a
      Status
       
      Valid
      2025-06-25
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      Esomeprazole Magnesium IH
      Issue/Submission Date
      2022-06-06
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      Dr. Reddy's Laboratories

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      2025-06-25
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      Esomeprazole Magnesium Trihydrate E...
      Issue/Submission Date
      2022-07-15
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      Suanfarma

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      Suanfarma

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      Zeon Pharma Industries India Pvt Lt...

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        Tagoor Laboratories

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          Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
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          Indian CDSCO WC-0494
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          Expired
          2024-02-26
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          Esomeprazole Magnesium USP/Esomepra...
          Issue/Submission Date
          2023-02-14
          Tagoor Laboratories

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          LGM Pharma

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          Booth #642

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          HRV Global Life Sciences

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            Minakem (formerly Delmar Chemicals)

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            Lee Pharma

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            Application Number
            34572
            R0-CEP 2021-334 - Rev 00
            Indian CDSCO WC-0186
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            Active
            Fees Unpaid
            Reviewed
            Valid
             
            Expired
            2022-07-28
            Filing Details
            ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
            Esomeprazole magnesium dihydrate
            Esomeprazole Magnesium dihydrate (P...
            Issue/Submission Date
            2020-02-18
            2022-05-03
            2019-09-27
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            Perrigo API India Private Limited

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            Application Number
            28163
            Status
            Inactive
            Fees Paid
            N/A
             
            Filing Details
            ESOMEPRAZOLE MAGNESIUM DIHYDRATE
            Issue/Submission Date
            2014-03-27
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            Viatris

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            Application Number
            23120
            R1-CEP 2015-023 - Rev 00
            Indian CDSCO WC-0359a3
            Status
            Active
            Fees Paid
            Reviewed
            Valid
             
            Expired
            2022-05-21
            Filing Details
            ESOMEPRAZOLE MAGNESIUM USP (AMORPHO...
            Esomeprazole magnesium trihydrate
            Esomeprazole Magnesium Trihydrate E...
            Issue/Submission Date
            2009-09-16
            2021-11-26
            2020-01-20
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            Srini Pharmaceuticals

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            Application Number
            32909
            R0-CEP 2019-113 - Rev 00
            Indian CDSCO WC-0313A2
            Status
            Active
            Fees Paid
            Reviewed
            Valid
             
            Expired
            2022-05-21
            Filing Details
            ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
            Esomeprazole magnesium trihydrate
            Esomeprazole Magnesium Trihydrate U...
            Issue/Submission Date
            2018-06-30
            2020-09-11
            2020-06-12
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            Viatris

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            Application Number
            27954
            R0-CEP 2023-164 - Rev 00
            Status
            Active
            Fees Paid
            Reviewed
            Valid
             
            Filing Details
            ESOMEPRAZOLE MAGNESIUM USP (AMORPHO...
            Esomeprazole magnesium trihydrate, ...
            Issue/Submission Date
            2014-03-13
            2023-06-23
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            Viatris

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            Application Number
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            ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
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            30076
            R0-CEP 2021-113 - Rev 00
            Indian CDSCO WC-0383A4
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            Expired
            2022-08-08
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            ESOMEPRAZOLE MAGNESIUM USP (DIHYDRA...
            Esomeprazole magnesium dihydrate
            Esomeprazole Magnesium USP
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            2015-12-31
            2022-11-25
            2019-10-15
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            Application Number
            30401
            R0-CEP 2019-253 - Rev 01
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            ESOMEPRAZOLE MAGNESIUM USP (TRIHYDR...
            Esomeprazole magnesium trihydrate
            Issue/Submission Date
            2016-03-30
            2023-02-21
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            Application Number
            38193
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            Raks Pharma

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            Application Number
            27472
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            ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
            Issue/Submission Date
            2013-09-17
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            ZHEJIANG JINHUA CONBA BIO-PHARM. CO...

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            Application Number
            29992
            Status
            Inactive
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            N/A
             
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            ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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            2015-11-04
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            Application Number
            29403
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            ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
            Issue/Submission Date
            2015-07-17
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            UQUIFA

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            Application Number
            30036
            R0-CEP 2016-088 - Rev 00
            Status
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            Fees Paid
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            Withdrawn by Holder
             
            Filing Details
            ESOMEPRAZOLE MAGNESIUM DIHYDRATE
            Esomeprazole magnesium dihydrate
            Issue/Submission Date
            2016-04-15
            2018-02-09
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            Zhejiang Yongtai Technology

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              Application Number
              30901
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              ESOMEPRAZOLE MAGNESIUM USP, NON-STE...
              Issue/Submission Date
              2016-09-15
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              Everest Organics

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              Application Number
              33443
              R1-CEP 2014-147 - Rev 00
              Indian CDSCO WC-0338
              Status
              Active
              Fees Unpaid
              Reviewed
              Valid
               
              Expired
              2022-04-14
              Filing Details
              ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
              Esomeprazole magnesium trihydrate
              Esomeprazole Magnesium Trihydrate E...
              Issue/Submission Date
              2018-12-20
              2021-09-07
              2019-04-15
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              Macleods Pharmaceuticals Limited

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              Application Number
              28523
              Indian CDSCO WC-0079
              Status
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              Fees Paid
              Reviewed
               
              Expired
              2022-07-02
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              ESOMEPRAZOLE MAGNESIUM DIHYDRATE
              Esomeprazole magnesium (USP)
              Issue/Submission Date
              2014-12-02
              2019-11-28
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              HEC Pharm

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              Application Number
              27918
              R1-CEP 2014-159 - Rev 00
              Status
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              Reviewed
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              Filing Details
              ESOMEPRAZOLE MAGNESIUM DIHYDRATE NO...
              Esomeprazole magnesium dihydrate
              Issue/Submission Date
              2014-04-08
              2020-05-20
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              Sun Pharmaceutical Industries Limit...

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              Application Number
              30175
              Indian CDSCO WC-0011
              Status
              Active
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              Reviewed
               
              Valid
              2025-06-02
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              ESOMEPRAZOLE MAGNESIUM USP (AMORPHO...
              Esomeprazole Magnesium Amorphous US...
              Issue/Submission Date
              2016-05-31
              2022-06-08
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              Application Number
              31094
              Status
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              ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
              Issue/Submission Date
              2016-12-30
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              Vasudha Pharma Chem

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              Application Number
              31975
              CEP 2017-191 - Rev 02
              Indian CDSCO WC-0287n
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              Reviewed
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              Expired
              2024-04-16
              Filing Details
              ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
              Esomeprazole magnesium trihydrate
              Esomeprazole Magnesium USP/Esomepra...
              Issue/Submission Date
              2017-09-08
              2024-02-15
              2021-05-11
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              Glenmark Life Sciences

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                Application Number
                20222
                R1-CEP 2014-258 - Rev 02
                303MF10113
                Indian CDSCO WC-0057n
                Status
                Active
                Fees Unpaid
                Reviewed
                Valid
                 
                Valid
                2025-06-25
                Filing Details
                ESOMEPRAZOLE
                Esomeprazole magnesium dihydrate
                Esomeprazole magnesium hydrate at 4...
                Esomeprazole Magnesium
                Issue/Submission Date
                2007-01-31
                2023-02-09
                2021-07-16
                2022-06-07
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                  Application Number
                  20392
                  Indian CDSCO WC-0310
                  Status
                  Active
                  Fees Unpaid
                  N/A
                   
                  Expired
                  2023-11-23
                  Filing Details
                  ESOMEPRAZOLE POTASSIUM
                  Esomeprazole Magnesium Trihydrate (...
                  Issue/Submission Date
                  2007-04-02
                  2021-01-08
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                  Glenmark Life Sciences

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                    Application Number
                    24338
                    Status
                    Active
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
                    Issue/Submission Date
                    2010-11-12
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                    Glenmark Life Sciences

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                      Application Number
                      26938
                      Status
                      Active
                      Fees Unpaid
                      Reviewed
                       
                      Filing Details
                      ESOMEPRAZOLE MAGNESIUM DIHYDRATE US...
                      Issue/Submission Date
                      2014-02-14
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                      Torrent Pharmaceuticals Limited

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                      Application Number
                      23110
                      Status
                      Active
                      Fees Paid
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                      Filing Details
                      ESOMEPRAZOLE MAGNESIUM USP
                      Issue/Submission Date
                      2009-09-14
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                      Torrent Pharmaceuticals Limited

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                      Application Number
                      27639
                      Status
                      Active
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                      Reviewed
                       
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                      ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
                      Issue/Submission Date
                      2013-10-31
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                      RANBAXY LABORATORIES LIMITED

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                      Application Number
                      18559
                      Status
                      Inactive
                      Fees Paid
                      N/A
                       
                      Filing Details
                      ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, ...
                      Issue/Submission Date
                      2005-08-03
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                      Shouguang Fukang Pharmaceutical Co....

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                      Application Number
                      28548
                      R0-CEP 2021-169 - Rev 00
                      303MF10042
                      Status
                      Active
                      Fees Paid
                      Reviewed
                      Valid
                       
                      Filing Details
                      ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
                      Esomeprazole magnesium dihydrate, P...
                      Esomeprazole magnesium hydrate at N...
                      Issue/Submission Date
                      2014-07-03
                      2021-07-29
                      2021-03-15
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                      Application Number
                      31924
                      R1-CEP 2016-027 - Rev 00
                      Status
                      Active
                      Fees Paid
                      N/A
                      Valid
                       
                      Filing Details
                      ESOMEPRAZOLE MAGNESIUM DIHYDRATE
                      Esomeprazole magnesium dihydrate
                      Issue/Submission Date
                      2017-07-15
                      2022-09-09
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                      Zhejiang Huayi Pharmaceutical Co., ...

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                      Application Number
                      R0-CEP 2014-318 - Rev 00
                      Status
                      Expired
                       
                      Filing Details
                      Esomeprazole magnesium trihydrate
                      Issue/Submission Date
                      2016-02-18
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                      • CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE
                      • CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
                      • CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE
                      • FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET
                      • FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET
                      • FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET
                      • FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET
                      • TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
                      • TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

                      Looking for 95382-33-5 / Esomeprazole Magnesium API manufacturers, exporters & distributors?

                      Esomeprazole Magnesium manufacturers, exporters & distributors 1

                      15

                      PharmaCompass offers a list of Esomeprazole Magnesium 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 Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier for your needs.

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

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

                      API | Excipient name

                      Esomeprazole Magnesium

                      Synonyms

                      Omeprazole magnesium, 161973-10-0, Prilosec otc, H 168/68 magnesium, 95382-33-5, Omeprazole (as magnesium)

                      Cas Number

                      95382-33-5

                      Unique Ingredient Identifier (UNII)

                      426QFE7XLK

                      About Esomeprazole Magnesium

                      The S-isomer of omeprazole.

                      Esomeprazole Manufacturers

                      A Esomeprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole, including repackagers and relabelers. The FDA regulates Esomeprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole 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 Esomeprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

                      Esomeprazole Suppliers

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

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

                      Esomeprazole Manufacturers | Traders | Suppliers

                      Esomeprazole Manufacturers, Traders, Suppliers 1
                      93

                      We have 88 companies offering Esomeprazole

                      Get in contact with the supplier of your choice:

                      1. Minakem
                      2. Tenatra Chemie
                      3. Temad Co
                      4. Rochem International Inc
                      5. Jai Radhe Sales
                      6. Metrochem API Private Limited
                      7. Dr. Reddy's Laboratories
                      8. Suanfarma
                      9. Zeon Pharma Industries India Pvt Ltd
                      10. Tagoor Laboratories
                      11. LGM Pharma
                      12. HRV Global Life Sciences
                      13. Minakem (formerly Delmar Chemicals)
                      14. Alkem Laboratories
                      15. Aurobindo Pharma Limited
                      16. Aurore Life Sciences
                      17. Cheer Fine Pharmaceutical
                      18. Chemeca Drugs
                      19. CHEMO
                      20. Chromo Laboratories
                      21. Cipla
                      22. Credo Life Sciences
                      23. DEAFARMA
                      24. Dishman Carbogen Amcis
                      25. Dr. Raju’s Pharma Solutions
                      26. ENAL DRUGS
                      27. Everest Organics
                      28. F.I.S. Fabbrica Italiana Sintetici
                      29. Glenmark Life Sciences
                      30. Glenmark Pharmaceuticals
                      31. GPT Pharmaceuticals
                      32. Granules India Limited
                      33. Green Stone Swiss Co ., Ltd
                      34. Guangzhou Tosun Pharmaceutical
                      35. Guilin Hwasun Pharmaceutical
                      36. HEC Pharm
                      37. Hetero Drugs
                      38. Hoventa Pharma
                      39. Hunan Warrant Chiral Pharmaceutical
                      40. Integrin Life Sciences
                      41. Jiangsu Zhongbang Pharmaceutical Co, Ltd
                      42. Jinzhou Jiutai Pharmaceutical
                      43. Jubilant Generics
                      44. Jubilant Pharmova
                      45. Kaliberr Labs
                      46. Krka
                      47. Laurus Labs
                      48. Lee Pharma
                      49. Lupin Ltd
                      50. Macleods Pharmaceuticals Limited
                      51. Meenaxy Pharma Pvt. Ltd
                      52. Micro Orgo Chem
                      53. MSN Laboratories
                      54. Murli Krishna Pharma
                      55. Nifty Labs
                      56. Ningbo Menovo Pharmaceutical
                      57. Nosch Labs Pvt. Ltd.
                      58. Oneiro Lifecare
                      59. Osmopharm
                      60. Pellets Pharma Limited
                      61. Perrigo API India Private Limited
                      62. Precise Group
                      63. Qilu Pharmaceutical
                      64. Qualitek pharma
                      65. RA CHEM PHARMA LIMITED
                      66. Raks Pharma
                      67. RANBAXY LABORATORIES LIMITED
                      68. SAINOR PHARMA PVT. LTD
                      69. Sandoz B2B
                      70. SGMR Pharmaceuticals
                      71. Shouguang Fukang Pharmaceutical Co., Ltd
                      72. Smilax Laboratories Limited
                      73. Spansules Pharma
                      74. Srini Pharmaceuticals
                      75. Sun Pharmaceutical Industries Limited
                      76. Tecoland Corporation
                      77. Titan Laboratories
                      78. Torrent Pharmaceuticals Limited
                      79. UQUIFA
                      80. Vasudha Pharma Chem
                      81. Viatris
                      82. Zhejiang Huayi Pharmaceutical Co., Ltd.
                      83. ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
                      84. Zhejiang Multinpharma
                      85. Zhejiang Yongtai Technology
                      86. Zhuhai Rundu Pharmaceutical
                      87. Zim Laboratories
                      88. 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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