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

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    01 Aripiprazole (1)

    02 Biperiden Hydrochloride (1)

    03 Bupropion Hydrochloride (1)

    04 Carisoprodol (1)

    05 Celecoxib (1)

    06 Clopidogrel (1)

    07 Dexlansoprazole (1)

    08 Diltiazem Hydrochloride (1)

    09 Domperidone (1)

    10 Duloxetine (1)

    11 Esomeprazole Magnesium (1)

    12 Fexofenadine Hydrochloride (1)

    13 Levetiracetam (1)

    14 Pantoprazole Sodium (1)

    15 Pirfenidone (1)

    16 Quetiapine Hemifumarate (1)

    17 Rabeprazole (1)

    18 Ropinirole Hydrochloride (1)

    19 Sertraline Hydrochloride (1)

    20 Tapentadol (1)

    21 Blank (1)

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    01 Active (9)

    02 Blank (12)

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    01 Valid (1)

    02 Blank (20)

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    01 Blank (21)

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    01 WC-0482 (2)

    02 Blank (19)

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      Clopidogrel

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      USDMF

      Found USDMF

      33710
      Active
      CLOPIDOGREL BISULFATE USP
      2021-02-05
      CEP/COS

      Found CEP/COS

      CEP 2021-433 - Rev 00
      Valid
      Clopidogrel hydrogen sulfate, Form ...
      2023-12-20
      Japanese DMF

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      Application Number
      33710
      CEP 2021-433 - Rev 00
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Filing Details
      CLOPIDOGREL BISULFATE USP
      Clopidogrel hydrogen sulfate, Form ...
      Issue/Submission Date
      2021-02-05
      2023-12-20
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        Sertraline Hydrochloride

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        USDMF

        Found USDMF

        33535
        Active
        SERTRALINE HYDROCHLORIDE USP
        2019-03-01
        CEP/COS

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        Japanese DMF

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        Written Confirmation

        Caution WC

        Indian CDSCO WC-0482
        Expired
        Sertraline Hydrochloride EP
        2020-08-03
        Application Number
        33535
        Indian CDSCO WC-0482
        Status
        Active
        Fees Unpaid
        Reviewed
         
        Expired
        2023-08-02
        Filing Details
        SERTRALINE HYDROCHLORIDE USP
        Sertraline Hydrochloride EP
        Issue/Submission Date
        2019-03-01
        2020-08-03
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          Bupropion Hydrochloride

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          USDMF

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          35418
          Active
          BUPROPION HYDROCHLORIDE USP
          2020-12-24
          CEP/COS

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          Application Number
          35418
          Status
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          BUPROPION HYDROCHLORIDE USP
          Issue/Submission Date
          2020-12-24
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            Carisoprodol

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            USDMF

            Found USDMF

            35149
            Active
            CARISOPRODOL USP
            2020-09-28
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            Application Number
            35149
            Status
            Active
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            CARISOPRODOL USP
            Issue/Submission Date
            2020-09-28
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              Celecoxib

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              USDMF

              Found USDMF

              37530
              Active
              CELECOXIB USP
              2023-01-12
              CEP/COS

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              Application Number
              37530
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              CELECOXIB USP
              Issue/Submission Date
              2023-01-12
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                Diltiazem Hydrochloride

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                USDMF

                Found USDMF

                34220
                Active
                DILTIAZEM HYDROCHLORIDE USP
                2020-02-15
                CEP/COS

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                Application Number
                34220
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Filing Details
                DILTIAZEM HYDROCHLORIDE USP
                Issue/Submission Date
                2020-02-15
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                  Fexofenadine Hydrochloride

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                  USDMF

                  Found USDMF

                  36554
                  Active
                  FEXOFENADINE HYDROCHLORIDE USP
                  2021-12-15
                  CEP/COS

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                  Japanese DMF

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                  Application Number
                  36554
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                   
                  Filing Details
                  FEXOFENADINE HYDROCHLORIDE USP
                  Issue/Submission Date
                  2021-12-15
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                    Quetiapine Hemifumarate

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                    USDMF

                    Found USDMF

                    37315
                    Active
                    QUETIAPINE FUMARATE USP
                    2022-07-26
                    CEP/COS

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                    Japanese DMF

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                    Written Confirmation

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                    Application Number
                    37315
                    Status
                    Active
                    Fees Unpaid
                    Reviewed
                     
                    Filing Details
                    QUETIAPINE FUMARATE USP
                    Issue/Submission Date
                    2022-07-26
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                      HYDRALAZINE HCL USP

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                      USDMF

                      Found USDMF

                      38732
                      Active
                      HYDRALAZINE HCL USP
                      2023-09-13
                      CEP/COS

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                      Japanese DMF

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                      Written Confirmation

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                      Application Number
                      38732
                      Status
                      Active
                      Fees Unpaid
                      Reviewed
                       
                      Filing Details
                      HYDRALAZINE HCL USP
                      Issue/Submission Date
                      2023-09-13
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                        Pirfenidone

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                        USDMF

                        Close USDMF

                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Caution WC

                        Indian CDSCO WC-0482
                        Expired
                        Pirfenidone EP
                        2020-08-03
                        Application Number
                        Indian CDSCO WC-0482
                        Status
                         
                        Expired
                        2023-08-02
                        Filing Details
                        Pirfenidone EP
                        Issue/Submission Date
                        2020-08-03
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