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

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    Glenmark Pharmaceuticals
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    Glenmark House, B. D. Sawant Marg, Chakala, Off Western Express Highway, Andheri (E), Mumbai - 400 099
    Telephone
    Telephone
    +91 22 4018 9999
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.glenmarkpharma.com/
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    Linkedin
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    Twitter

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      Adapalene

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      USDMF

      Found USDMF

      18756
      Active
      ADAPALENE USP
      2005-09-12
      CEP/COS

      Found CEP/COS

      R1-CEP 2012-207 - Rev 01
      Valid
      Adapalene
      2022-12-06
      Japanese DMF

      Found JDMF

      226MF10072
      Adapalene at 4th Floor, OIA House, ...
      2014-03-11
      Written Confirmation

      Found WC

      Indian CDSCO WC-0057n
      Valid
      Adapalene Ph. Eur./BP
      2022-06-07
      Application Number
      18756
      R1-CEP 2012-207 - Rev 01
      226MF10072
      Indian CDSCO WC-0057n
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Valid
      2025-06-25
      Filing Details
      ADAPALENE USP
      Adapalene
      Adapalene at 4th Floor, OIA House, ...
      Adapalene Ph. Eur./BP
      Issue/Submission Date
      2005-09-12
      2022-12-06
      2014-03-11
      2022-06-07
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        Esomeprazole Magnesium

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        USDMF

        Found USDMF

        20222
        Active
        ESOMEPRAZOLE
        2007-01-31
        CEP/COS

        Found CEP/COS

        R1-CEP 2014-258 - Rev 02
        Valid
        Esomeprazole magnesium dihydrate
        2023-02-09
        Japanese DMF

        Found JDMF

        303MF10113
        Esomeprazole magnesium hydrate at 4...
        2021-07-16
        Written Confirmation

        Found WC

        Indian CDSCO WC-0057n
        Valid
        Esomeprazole Magnesium
        2022-06-07
        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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          Rizatriptan Benzoate

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          USDMF

          Found USDMF

          22676
          Active
          RIZATRIPTAN BENZOATE USP
          2009-03-31
          CEP/COS

          Found CEP/COS

          R1-CEP 2012-108 - Rev 02
          Valid
          Rizatriptan benzoate
          2022-12-05
          Japanese DMF

          Found JDMF

          228MF10064
          Rizatriptan benzoate at 4th Floor, ...
          2016-02-24
          Written Confirmation

          Found WC

          Indian CDSCO WC-0057n
          Valid
          Rizatriptan Benzoate Ph. Eur.
          2022-06-07
          Application Number
          22676
          R1-CEP 2012-108 - Rev 02
          228MF10064
          Indian CDSCO WC-0057n
          Status
          Active
          Fees Unpaid
          N/A
          Valid
           
          Valid
          2025-06-25
          Filing Details
          RIZATRIPTAN BENZOATE USP
          Rizatriptan benzoate
          Rizatriptan benzoate at 4th Floor, ...
          Rizatriptan Benzoate Ph. Eur.
          Issue/Submission Date
          2009-03-31
          2022-12-05
          2016-02-24
          2022-06-07
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            Ropinirole Hydrochloride

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            USDMF

            Found USDMF

            20593
            Active
            ROPINIROLE HYDROCHLORIDE USP
            2007-06-12
            CEP/COS

            Found CEP/COS

            R0-CEP 2017-242 - Rev 01
            Valid
            Ropinirole hydrochloride
            2022-12-13
            Japanese DMF

            Found JDMF

            227MF10031
            Ropinirole hydrochloride at 4th Flo...
            2015-01-23
            Written Confirmation

            Found WC

            Indian CDSCO WC-0057n
            Valid
            Ropinirole HCl USP
            2022-06-07
            Application Number
            20593
            R0-CEP 2017-242 - Rev 01
            227MF10031
            Indian CDSCO WC-0057n
            Status
            Active
            Fees Unpaid
            Reviewed
            Valid
             
            Valid
            2025-06-25
            Filing Details
            ROPINIROLE HYDROCHLORIDE USP
            Ropinirole hydrochloride
            Ropinirole hydrochloride at 4th Flo...
            Ropinirole HCl USP
            Issue/Submission Date
            2007-06-12
            2022-12-13
            2015-01-23
            2022-06-07
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              Tadalafil

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              USDMF

              Found USDMF

              22530
              Active
              TADALAFIL
              2009-02-16
              CEP/COS

              Found CEP/COS

              R1-CEP 2016-040 - Rev 00
              Valid
              Tadalafil, D150 process
              2022-06-29
              Japanese DMF

              Found JDMF

              231MF10055
              Tadalafil at 4th Floor, OIA House, ...
              2019-02-25
              Written Confirmation

              Found WC

              Indian CDSCO WC-0057n
              Valid
              Tadalafil Ph. Eur.
              2022-06-07
              Application Number
              22530
              R1-CEP 2016-040 - Rev 00
              231MF10055
              Indian CDSCO WC-0057n
              Status
              Active
              Fees Unpaid
              N/A
              Valid
               
              Valid
              2025-06-25
              Filing Details
              TADALAFIL
              Tadalafil, D150 process
              Tadalafil at 4th Floor, OIA House, ...
              Tadalafil Ph. Eur.
              Issue/Submission Date
              2009-02-16
              2022-06-29
              2019-02-25
              2022-06-07
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                Voriconazole

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                USDMF

                Found USDMF

                24717
                Active
                VORICONAZOLE USP
                2011-03-31
                CEP/COS

                Found CEP/COS

                R1-CEP 2012-102 - Rev 02
                Valid
                Voriconazole
                2022-12-05
                Japanese DMF

                Found JDMF

                225MF10092
                Voriconazole at 4th Floor, OIA Hous...
                2013-05-08
                Written Confirmation

                Found WC

                Indian CDSCO WC-0057n
                Valid
                Voriconazole (Ph.Eur)
                2022-06-07
                Application Number
                24717
                R1-CEP 2012-102 - Rev 02
                225MF10092
                Indian CDSCO WC-0057n
                Status
                Active
                Fees Unpaid
                Reviewed
                Valid
                 
                Valid
                2025-06-25
                Filing Details
                VORICONAZOLE USP
                Voriconazole
                Voriconazole at 4th Floor, OIA Hous...
                Voriconazole (Ph.Eur)
                Issue/Submission Date
                2011-03-31
                2022-12-05
                2013-05-08
                2022-06-07
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                  Zolpidem Tartrate

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                  USDMF

                  Found USDMF

                  18164
                  Active
                  ZOLPIDEM TARTRATE USP
                  2005-03-14
                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2007-102 - Rev 04
                  Valid
                  Zolpidem tartrate
                  2022-12-05
                  Japanese DMF

                  Found JDMF

                  227MF10236
                  Zolpidem tartrate at 4th Floor, OIA...
                  2015-09-24
                  Written Confirmation

                  Found WC

                  Indian CDSCO WC-0057n
                  Valid
                  Zolpidem Tartarate Ph. Eur./USP/BP
                  2022-06-07
                  Application Number
                  18164
                  R1-CEP 2007-102 - Rev 04
                  227MF10236
                  Indian CDSCO WC-0057n
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                  Valid
                   
                  Valid
                  2025-06-25
                  Filing Details
                  ZOLPIDEM TARTRATE USP
                  Zolpidem tartrate
                  Zolpidem tartrate at 4th Floor, OIA...
                  Zolpidem Tartarate Ph. Eur./USP/BP
                  Issue/Submission Date
                  2005-03-14
                  2022-12-05
                  2015-09-24
                  2022-06-07
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                    Telmisartan

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                    USDMF

                    Found USDMF

                    27804
                    Active
                    TELMISARTAN USP (D297 PROCESS)
                    2014-05-23
                    CEP/COS

                    Found CEP/COS

                    R1-CEP 2009-028 - Rev 06
                    Valid
                    Telmisartan
                    2022-12-06
                    Japanese DMF

                    Found JDMF

                    225MF10093
                    Telmisartan at Glenmark House, HDO ...
                    2013-05-08
                    Written Confirmation

                    Caution WC

                    Indian CDSCO WC-0310A3-4
                    Expired
                    Telmisartan JP
                    2022-05-27
                    Application Number
                    27804
                    R1-CEP 2009-028 - Rev 06
                    225MF10093
                    Indian CDSCO WC-0310A3-4
                    Status
                    Active
                    Fees Unpaid
                    Reviewed
                    Valid
                     
                    Expired
                    2023-11-23
                    Filing Details
                    TELMISARTAN USP (D297 PROCESS)
                    Telmisartan
                    Telmisartan at Glenmark House, HDO ...
                    Telmisartan JP
                    Issue/Submission Date
                    2014-05-23
                    2022-12-06
                    2013-05-08
                    2022-05-27
                    ASK
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                      Telmisartan

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                      USDMF

                      Caution USDMF

                      20575
                      Inactive
                      TELMISARTAN USP
                      2007-05-25
                      CEP/COS

                      Found CEP/COS

                      R0-CEP 2022-047 - Rev 01
                      Valid
                      Telmisartan, Process II
                      2023-01-16
                      Japanese DMF

                      Found JDMF

                      228MF10025
                      Telmisartan at 4th Floor, OIA House...
                      2016-02-02
                      Written Confirmation

                      Found WC

                      Indian CDSCO WC-0057n
                      Valid
                      Telmisartan Ph. Eur./USP/BP
                      2022-06-07
                      Application Number
                      20575
                      R0-CEP 2022-047 - Rev 01
                      228MF10025
                      Indian CDSCO WC-0057n
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                      Valid
                       
                      Valid
                      2025-06-25
                      Filing Details
                      TELMISARTAN USP
                      Telmisartan, Process II
                      Telmisartan at 4th Floor, OIA House...
                      Telmisartan Ph. Eur./USP/BP
                      Issue/Submission Date
                      2007-05-25
                      2023-01-16
                      2016-02-02
                      2022-06-07
                      ASK
                      US
                      PHARMACOMPASS
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                      your Marketing & Sales content
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                        Amiodarone Hydrochloride

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                        USDMF

                        Found USDMF

                        16787
                        Active
                        AMIODARONE HYDROCHLORIDE USP
                        2003-08-27
                        CEP/COS

                        Found CEP/COS

                        R1-CEP 2003-216 - Rev 09
                        Valid
                        Amiodarone hydrochloride
                        2022-12-06
                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Found WC

                        Indian CDSCO WC-0057n
                        Valid
                        Amiodarone HCl Ph. Eur./USP/BP
                        2022-06-07
                        Application Number
                        16787
                        R1-CEP 2003-216 - Rev 09
                        Indian CDSCO WC-0057n
                        Status
                        Active
                        Fees Unpaid
                        Reviewed
                        Valid
                         
                        Valid
                        2025-06-25
                        Filing Details
                        AMIODARONE HYDROCHLORIDE USP
                        Amiodarone hydrochloride
                        Amiodarone HCl Ph. Eur./USP/BP
                        Issue/Submission Date
                        2003-08-27
                        2022-12-06
                        2022-06-07
                        ASK
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                        your Marketing & Sales content
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                          Atovaquone

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                          USDMF

                          Found USDMF

                          22121
                          Active
                          ATOVAQUONE, USP
                          2008-10-27
                          CEP/COS

                          Found CEP/COS

                          R1-CEP 2015-346 - Rev 01
                          Valid
                          Atovaquone
                          2022-12-02
                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Found WC

                          Indian CDSCO WC-0057n
                          Valid
                          Atovaquone USP
                          2022-06-07
                          Application Number
                          22121
                          R1-CEP 2015-346 - Rev 01
                          Indian CDSCO WC-0057n
                          Status
                          Active
                          Fees Unpaid
                          Reviewed
                          Valid
                           
                          Valid
                          2025-06-25
                          Filing Details
                          ATOVAQUONE, USP
                          Atovaquone
                          Atovaquone USP
                          Issue/Submission Date
                          2008-10-27
                          2022-12-02
                          2022-06-07
                          ASK
                          US
                          PHARMACOMPASS
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                            Bosentan Hydrate

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                            USDMF

                            Found USDMF

                            24124
                            Active
                            BOSENTAN
                            2010-09-09
                            CEP/COS

                            Close CEP/COS

                            Japanese DMF

                            Found JDMF

                            227MF10295
                            Bosentan hydrate at Glenmark House,...
                            2015-12-24
                            Written Confirmation

                            Found WC

                            Indian CDSCO WC-0057n
                            Valid
                            Bosentan Monohydrate IH
                            2022-06-07
                            Application Number
                            24124
                            227MF10295
                            Indian CDSCO WC-0057n
                            Status
                            Active
                            Fees Unpaid
                            N/A
                             
                            Valid
                            2025-06-25
                            Filing Details
                            BOSENTAN
                            Bosentan hydrate at Glenmark House,...
                            Bosentan Monohydrate IH
                            Issue/Submission Date
                            2010-09-09
                            2015-12-24
                            2022-06-07
                            ASK
                            US
                            PHARMACOMPASS
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                              Deferasirox

                              PDF Supplier PDF
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                              USDMF

                              Found USDMF

                              24209
                              Active
                              DEFERASIROX
                              2010-10-28
                              CEP/COS

                              Found CEP/COS

                              R0-CEP 2021-148 - Rev 00
                              Valid
                              Deferasirox
                              2023-04-04
                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Found WC

                              Indian CDSCO WC-0057n
                              Valid
                              Deferasirox IH
                              2022-06-07
                              Application Number
                              24209
                              R0-CEP 2021-148 - Rev 00
                              Indian CDSCO WC-0057n
                              Status
                              Active
                              Fees Unpaid
                              Reviewed
                              Valid
                               
                              Valid
                              2025-06-25
                              Filing Details
                              DEFERASIROX
                              Deferasirox
                              Deferasirox IH
                              Issue/Submission Date
                              2010-10-28
                              2023-04-04
                              2022-06-07
                              ASK
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                                Desloratadine

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                                USDMF

                                Found USDMF

                                19428
                                Active
                                DESLORATADINE
                                2006-05-12
                                CEP/COS

                                Found CEP/COS

                                R1-CEP 2014-047 - Rev 02
                                Valid
                                Desloratadine
                                2023-03-27
                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Found WC

                                Indian CDSCO WC-0057n
                                Valid
                                Desloratadine
                                2022-06-07
                                Application Number
                                19428
                                R1-CEP 2014-047 - Rev 02
                                Indian CDSCO WC-0057n
                                Status
                                Active
                                Fees Unpaid
                                N/A
                                Valid
                                 
                                Valid
                                2025-06-25
                                Filing Details
                                DESLORATADINE
                                Desloratadine
                                Desloratadine
                                Issue/Submission Date
                                2006-05-12
                                2023-03-27
                                2022-06-07
                                ASK
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                                  Eszopiclone

                                  PDF Supplier PDF
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                                  See Less

                                  USDMF

                                  Found USDMF

                                  21853
                                  Active
                                  ESZOPICLONE USP
                                  2008-08-04
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Found JDMF

                                  302MF10028
                                  Eszopiclone at 4th Floor, OIA House...
                                  2020-02-13
                                  Written Confirmation

                                  Found WC

                                  Indian CDSCO WC-0057n
                                  Valid
                                  Eszopiclone (IH
                                  2022-06-07
                                  Application Number
                                  21853
                                  302MF10028
                                  Indian CDSCO WC-0057n
                                  Status
                                  Active
                                  Fees Unpaid
                                  N/A
                                   
                                  Valid
                                  2025-06-25
                                  Filing Details
                                  ESZOPICLONE USP
                                  Eszopiclone at 4th Floor, OIA House...
                                  Eszopiclone (IH
                                  Issue/Submission Date
                                  2008-08-04
                                  2020-02-13
                                  2022-06-07
                                  ASK
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                                    Ezetimibe

                                    PDF Supplier PDF
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                                    USDMF

                                    Found USDMF

                                    19717
                                    Active
                                    EZETIMIBE (PROCESS I)
                                    2006-08-30
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Found JDMF

                                    303MF10083
                                    Ezetimibe at 4th Floor, OIA House, ...
                                    2021-06-01
                                    Written Confirmation

                                    Found WC

                                    Indian CDSCO WC-0057n
                                    Valid
                                    Ezetimibe
                                    2022-06-07
                                    Application Number
                                    19717
                                    303MF10083
                                    Indian CDSCO WC-0057n
                                    Status
                                    Active
                                    Fees Unpaid
                                    N/A
                                     
                                    Valid
                                    2025-06-25
                                    Filing Details
                                    EZETIMIBE (PROCESS I)
                                    Ezetimibe at 4th Floor, OIA House, ...
                                    Ezetimibe
                                    Issue/Submission Date
                                    2006-08-30
                                    2021-06-01
                                    2022-06-07
                                    ASK
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                                      Fingolimod Hydrochloride

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                                      USDMF

                                      Found USDMF

                                      26807
                                      Active
                                      FINGOLIMOD HYDROCHLORIDE USP
                                      2013-02-20
                                      CEP/COS

                                      Found CEP/COS

                                      R0-CEP 2020-108 - Rev 00
                                      Valid
                                      Fingolimod hydrochloride
                                      2022-06-30
                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Found WC

                                      Indian CDSCO WC-0057n
                                      Valid
                                      Fingolimod Hydrochloride (1H)
                                      2022-06-07
                                      Application Number
                                      26807
                                      R0-CEP 2020-108 - Rev 00
                                      Indian CDSCO WC-0057n
                                      Status
                                      Active
                                      Fees Unpaid
                                      Reviewed
                                      Valid
                                       
                                      Valid
                                      2025-06-25
                                      Filing Details
                                      FINGOLIMOD HYDROCHLORIDE USP
                                      Fingolimod hydrochloride
                                      Fingolimod Hydrochloride (1H)
                                      Issue/Submission Date
                                      2013-02-20
                                      2022-06-30
                                      2022-06-07
                                      ASK
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                                        Fluconazole

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                                        USDMF

                                        Found USDMF

                                        20734
                                        Active
                                        FLUCONAZOLE USP
                                        2007-07-31
                                        CEP/COS

                                        Found CEP/COS

                                        R1-CEP 2007-100 - Rev 02
                                        Valid
                                        Fluconazole
                                        2022-12-05
                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Found WC

                                        Indian CDSCO WC-0057n
                                        Valid
                                        Fluconazole Ph. Eur./USP/BP
                                        2022-06-07
                                        Application Number
                                        20734
                                        R1-CEP 2007-100 - Rev 02
                                        Indian CDSCO WC-0057n
                                        Status
                                        Active
                                        Fees Unpaid
                                        N/A
                                        Valid
                                         
                                        Valid
                                        2025-06-25
                                        Filing Details
                                        FLUCONAZOLE USP
                                        Fluconazole
                                        Fluconazole Ph. Eur./USP/BP
                                        Issue/Submission Date
                                        2007-07-31
                                        2022-12-05
                                        2022-06-07
                                        ASK
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                                          Glimepiride

                                          PDF Supplier PDF
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                                          USDMF

                                          Found USDMF

                                          17594
                                          Active
                                          GLIMEPIRIDE USP
                                          2004-08-12
                                          CEP/COS

                                          Found CEP/COS

                                          CEP 2022-481 - Rev 00
                                          Valid
                                          Glimepiride, Process-II
                                          2023-09-22
                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Found WC

                                          Indian CDSCO WC-0057n
                                          Valid
                                          Glimepiride Ph. Eur./USP/BP
                                          2022-06-07
                                          Application Number
                                          17594
                                          CEP 2022-481 - Rev 00
                                          Indian CDSCO WC-0057n
                                          Status
                                          Active
                                          Fees Unpaid
                                          N/A
                                          Valid
                                           
                                          Valid
                                          2025-06-25
                                          Filing Details
                                          GLIMEPIRIDE USP
                                          Glimepiride, Process-II
                                          Glimepiride Ph. Eur./USP/BP
                                          Issue/Submission Date
                                          2004-08-12
                                          2023-09-22
                                          2022-06-07
                                          ASK
                                          US
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                                            Lacosamide

                                            PDF Supplier PDF
                                            URL Supplier Web Content
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                                            USDMF

                                            Found USDMF

                                            26323
                                            Active
                                            LACOSAMIDE USP
                                            2012-10-15
                                            CEP/COS

                                            Found CEP/COS

                                            R0-CEP 2021-163 - Rev 01
                                            Valid
                                            Lacosamide
                                            2022-12-05
                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Found WC

                                            Indian CDSCO WC-0057n
                                            Valid
                                            TT_acosamide (H)
                                            2022-06-07
                                            Application Number
                                            26323
                                            R0-CEP 2021-163 - Rev 01
                                            Indian CDSCO WC-0057n
                                            Status
                                            Active
                                            Fees Unpaid
                                            Reviewed
                                            Valid
                                             
                                            Valid
                                            2025-06-25
                                            Filing Details
                                            LACOSAMIDE USP
                                            Lacosamide
                                            TT_acosamide (H)
                                            Issue/Submission Date
                                            2012-10-15
                                            2022-12-05
                                            2022-06-07
                                            ASK
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                                              Linezolid

                                              PDF Supplier PDF
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                                              USDMF

                                              Found USDMF

                                              19746
                                              Active
                                              LINEZOLID
                                              2006-09-11
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Found JDMF

                                              229MF10166
                                              Linezolid at Glenmark House, HDO Co...
                                              2017-08-22
                                              Written Confirmation

                                              Found WC

                                              Indian CDSCO WC-0057n
                                              Valid
                                              Linezolid (H)
                                              2022-06-07
                                              Application Number
                                              19746
                                              229MF10166
                                              Indian CDSCO WC-0057n
                                              Status
                                              Active
                                              Fees Unpaid
                                              N/A
                                               
                                              Valid
                                              2025-06-25
                                              Filing Details
                                              LINEZOLID
                                              Linezolid at Glenmark House, HDO Co...
                                              Linezolid (H)
                                              Issue/Submission Date
                                              2006-09-11
                                              2017-08-22
                                              2022-06-07
                                              ASK
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                                                Milnacipran Hydrochloride

                                                PDF Supplier PDF
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                                                USDMF

                                                Found USDMF

                                                25022
                                                Active
                                                MILNACIPRAN HYDROCHLORIDE
                                                2011-06-27
                                                CEP/COS

                                                Close CEP/COS

                                                Japanese DMF

                                                Found JDMF

                                                223MF10075
                                                Milnacipran hydrochloride at 4th Fl...
                                                2011-05-31
                                                Written Confirmation

                                                Found WC

                                                Indian CDSCO WC-0057n
                                                Valid
                                                Milnacipran Hydrochloride (IH)
                                                2022-06-07
                                                Application Number
                                                25022
                                                223MF10075
                                                Indian CDSCO WC-0057n
                                                Status
                                                Active
                                                Fees Unpaid
                                                Reviewed
                                                 
                                                Valid
                                                2025-06-25
                                                Filing Details
                                                MILNACIPRAN HYDROCHLORIDE
                                                Milnacipran hydrochloride at 4th Fl...
                                                Milnacipran Hydrochloride (IH)
                                                Issue/Submission Date
                                                2011-06-27
                                                2011-05-31
                                                2022-06-07
                                                ASK
                                                US
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                                                  Olmesartan Medoxomil

                                                  PDF Supplier PDF
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                                                  USDMF

                                                  Found USDMF

                                                  19141
                                                  Active
                                                  OLMESARTAN MEDOXOMIL, USP
                                                  2006-01-31
                                                  CEP/COS

                                                  Found CEP/COS

                                                  R1-CEP 2016-111 - Rev 00
                                                  Valid
                                                  Olmesartan medoxomil, Process II
                                                  2022-04-14
                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Found WC

                                                  Indian CDSCO WC-0057n
                                                  Valid
                                                  Olmesartan Medoxomil Ph. Eur.
                                                  2022-06-07
                                                  Application Number
                                                  19141
                                                  R1-CEP 2016-111 - Rev 00
                                                  Indian CDSCO WC-0057n
                                                  Status
                                                  Active
                                                  Fees Unpaid
                                                  Reviewed
                                                  Valid
                                                   
                                                  Valid
                                                  2025-06-25
                                                  Filing Details
                                                  OLMESARTAN MEDOXOMIL, USP
                                                  Olmesartan medoxomil, Process II
                                                  Olmesartan Medoxomil Ph. Eur.
                                                  Issue/Submission Date
                                                  2006-01-31
                                                  2022-04-14
                                                  2022-06-07
                                                  ASK
                                                  US
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                                                    Perindopril Erbumine

                                                    PDF Supplier PDF
                                                    URL Supplier Web Content
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                                                    USDMF

                                                    Found USDMF

                                                    17713
                                                    Active
                                                    PERINDOPRIL ERBUMINE
                                                    2004-09-30
                                                    CEP/COS

                                                    Found CEP/COS

                                                    R1-CEP 2004-279 - Rev 05
                                                    Valid
                                                    Perindopril tert-butylamine
                                                    2022-12-05
                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Found WC

                                                    Indian CDSCO WC-0057n
                                                    Valid
                                                    Perindopril Erbumine Ph. Eur./BP
                                                    2022-06-07
                                                    Application Number
                                                    17713
                                                    R1-CEP 2004-279 - Rev 05
                                                    Indian CDSCO WC-0057n
                                                    Status
                                                    Active
                                                    Fees Unpaid
                                                    N/A
                                                    Valid
                                                     
                                                    Valid
                                                    2025-06-25
                                                    Filing Details
                                                    PERINDOPRIL ERBUMINE
                                                    Perindopril tert-butylamine
                                                    Perindopril Erbumine Ph. Eur./BP
                                                    Issue/Submission Date
                                                    2004-09-30
                                                    2022-12-05
                                                    2022-06-07
                                                    ASK
                                                    US
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                                                      Rosuvastatin Calcium

                                                      PDF Supplier PDF
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                                                      USDMF

                                                      Found USDMF

                                                      20592
                                                      Active
                                                      ROSUVASTATIN CALCIUM
                                                      2007-06-12
                                                      CEP/COS

                                                      Found CEP/COS

                                                      R0-CEP 2022-377 - Rev 00
                                                      Valid
                                                      Rosuvastatin calcium, Process III
                                                      2023-02-21
                                                      Japanese DMF

                                                      Close JDMF

                                                      Written Confirmation

                                                      Found WC

                                                      Indian CDSCO WC-0057n
                                                      Valid
                                                      Rosuvastatin Calcium
                                                      2022-06-07
                                                      Application Number
                                                      20592
                                                      R0-CEP 2022-377 - Rev 00
                                                      Indian CDSCO WC-0057n
                                                      Status
                                                      Active
                                                      Fees Unpaid
                                                      N/A
                                                      Valid
                                                       
                                                      Valid
                                                      2025-06-25
                                                      Filing Details
                                                      ROSUVASTATIN CALCIUM
                                                      Rosuvastatin calcium, Process III
                                                      Rosuvastatin Calcium
                                                      Issue/Submission Date
                                                      2007-06-12
                                                      2023-02-21
                                                      2022-06-07
                                                      ASK
                                                      US
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                                                        Solifenacin Succinate

                                                        PDF Supplier PDF
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                                                        USDMF

                                                        Found USDMF

                                                        22418
                                                        Active
                                                        SOLIFENACIN SUCCINATE
                                                        2009-01-16
                                                        CEP/COS

                                                        Found CEP/COS

                                                        R0-CEP 2017-249 - Rev 01
                                                        Valid
                                                        Solifenacin succinate
                                                        2022-12-02
                                                        Japanese DMF

                                                        Close JDMF

                                                        Written Confirmation

                                                        Found WC

                                                        Indian CDSCO WC-0057n
                                                        Valid
                                                        Solifenacin Succinate
                                                        2022-06-07
                                                        Application Number
                                                        22418
                                                        R0-CEP 2017-249 - Rev 01
                                                        Indian CDSCO WC-0057n
                                                        Status
                                                        Active
                                                        Fees Unpaid
                                                        Reviewed
                                                        Valid
                                                         
                                                        Valid
                                                        2025-06-25
                                                        Filing Details
                                                        SOLIFENACIN SUCCINATE
                                                        Solifenacin succinate
                                                        Solifenacin Succinate
                                                        Issue/Submission Date
                                                        2009-01-16
                                                        2022-12-02
                                                        2022-06-07
                                                        ASK
                                                        US
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                                                          Terbinafine Hydrochloride

                                                          PDF Supplier PDF
                                                          URL Supplier Web Content
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                                                          USDMF

                                                          Found USDMF

                                                          18175
                                                          Active
                                                          TERBINAFINE HYDROCHLORIDE, USP
                                                          2005-03-14
                                                          CEP/COS

                                                          Found CEP/COS

                                                          R1-CEP 2007-316 - Rev 03
                                                          Valid
                                                          Terbinafine hydrochloride
                                                          2022-12-02
                                                          Japanese DMF

                                                          Close JDMF

                                                          Written Confirmation

                                                          Found WC

                                                          Indian CDSCO WC-0057n
                                                          Valid
                                                          Terbinafine HCl Ph.Eur./USP/BP
                                                          2022-06-07
                                                          Application Number
                                                          18175
                                                          R1-CEP 2007-316 - Rev 03
                                                          Indian CDSCO WC-0057n
                                                          Status
                                                          Active
                                                          Fees Unpaid
                                                          N/A
                                                          Valid
                                                           
                                                          Valid
                                                          2025-06-25
                                                          Filing Details
                                                          TERBINAFINE HYDROCHLORIDE, USP
                                                          Terbinafine hydrochloride
                                                          Terbinafine HCl Ph.Eur./USP/BP
                                                          Issue/Submission Date
                                                          2005-03-14
                                                          2022-12-02
                                                          2022-06-07
                                                          ASK
                                                          US
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                                                            Topiramate

                                                            PDF Supplier PDF
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                                                            USDMF

                                                            Found USDMF

                                                            17729
                                                            Active
                                                            TOPIRAMATE USP
                                                            2004-10-06
                                                            CEP/COS

                                                            Close CEP/COS

                                                            Japanese DMF

                                                            Found JDMF

                                                            227MF10208
                                                            Topiramate at Glenmark House, HDO C...
                                                            2015-08-11
                                                            Written Confirmation

                                                            Found WC

                                                            Indian CDSCO WC-0057n
                                                            Valid
                                                            Topiramate USP
                                                            2022-06-07
                                                            Application Number
                                                            17729
                                                            227MF10208
                                                            Indian CDSCO WC-0057n
                                                            Status
                                                            Active
                                                            Fees Unpaid
                                                            Reviewed
                                                             
                                                            Valid
                                                            2025-06-25
                                                            Filing Details
                                                            TOPIRAMATE USP
                                                            Topiramate at Glenmark House, HDO C...
                                                            Topiramate USP
                                                            Issue/Submission Date
                                                            2004-10-06
                                                            2015-08-11
                                                            2022-06-07
                                                            ASK
                                                            US
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                                                              Trospium Chloride

                                                              PDF Supplier PDF
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                                                              USDMF

                                                              Found USDMF

                                                              22673
                                                              Active
                                                              TROSPIUM CHLORIDE USP
                                                              2009-03-30
                                                              CEP/COS

                                                              Found CEP/COS

                                                              R1-CEP 2010-040 - Rev 03
                                                              Valid
                                                              Trospium chloride
                                                              2022-12-02
                                                              Japanese DMF

                                                              Close JDMF

                                                              Written Confirmation

                                                              Found WC

                                                              Indian CDSCO WC-0057n
                                                              Valid
                                                              Trospium Chloride Ph. Eur./BP
                                                              2022-06-07
                                                              Application Number
                                                              22673
                                                              R1-CEP 2010-040 - Rev 03
                                                              Indian CDSCO WC-0057n
                                                              Status
                                                              Active
                                                              Fees Unpaid
                                                              Reviewed
                                                              Valid
                                                               
                                                              Valid
                                                              2025-06-25
                                                              Filing Details
                                                              TROSPIUM CHLORIDE USP
                                                              Trospium chloride
                                                              Trospium Chloride Ph. Eur./BP
                                                              Issue/Submission Date
                                                              2009-03-30
                                                              2022-12-02
                                                              2022-06-07
                                                              ASK
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                                                                Zolmitriptan

                                                                PDF Supplier PDF
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                                                                USDMF

                                                                Found USDMF

                                                                22237
                                                                Active
                                                                ZOLMITRIPTAN USP
                                                                2008-12-02
                                                                CEP/COS

                                                                Close CEP/COS

                                                                Japanese DMF

                                                                Found JDMF

                                                                225MF10214
                                                                Zolmitriptan at Glenmark House, HDO...
                                                                2013-11-20
                                                                Written Confirmation

                                                                Found WC

                                                                Indian CDSCO WC-0057n
                                                                Valid
                                                                Zolmitriptan
                                                                2022-06-07
                                                                Application Number
                                                                22237
                                                                225MF10214
                                                                Indian CDSCO WC-0057n
                                                                Status
                                                                Active
                                                                Fees Unpaid
                                                                Reviewed
                                                                 
                                                                Valid
                                                                2025-06-25
                                                                Filing Details
                                                                ZOLMITRIPTAN USP
                                                                Zolmitriptan at Glenmark House, HDO...
                                                                Zolmitriptan
                                                                Issue/Submission Date
                                                                2008-12-02
                                                                2013-11-20
                                                                2022-06-07
                                                                ASK
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                                                                  Zonisamide

                                                                  PDF Supplier PDF
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                                                                  USDMF

                                                                  Found USDMF

                                                                  17945
                                                                  Active
                                                                  ZONISAMIDE
                                                                  2004-12-29
                                                                  CEP/COS

                                                                  Close CEP/COS

                                                                  Japanese DMF

                                                                  Found JDMF

                                                                  305MF10014
                                                                  Zonisamide at 4th Floor, OIA House,...
                                                                  2023-02-02
                                                                  Written Confirmation

                                                                  Found WC

                                                                  Indian CDSCO WC-0057n
                                                                  Valid
                                                                  Zonisamide (USP)
                                                                  2022-06-07
                                                                  Application Number
                                                                  17945
                                                                  305MF10014
                                                                  Indian CDSCO WC-0057n
                                                                  Status
                                                                  Active
                                                                  Fees Unpaid
                                                                  N/A
                                                                   
                                                                  Valid
                                                                  2025-06-25
                                                                  Filing Details
                                                                  ZONISAMIDE
                                                                  Zonisamide at 4th Floor, OIA House,...
                                                                  Zonisamide (USP)
                                                                  Issue/Submission Date
                                                                  2004-12-29
                                                                  2023-02-02
                                                                  2022-06-07
                                                                  ASK
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                                                                    Dipyridamole

                                                                    PDF Supplier PDF
                                                                    URL Supplier Web Content
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                                                                    USDMF

                                                                    Found USDMF

                                                                    29020
                                                                    Active
                                                                    DIPYRIDAMOLE USP
                                                                    2015-03-31
                                                                    CEP/COS

                                                                    Found CEP/COS

                                                                    R0-CEP 2017-023 - Rev 01
                                                                    Valid
                                                                    Dipyridamole
                                                                    2022-12-02
                                                                    Japanese DMF

                                                                    Close JDMF

                                                                    Written Confirmation

                                                                    Caution WC

                                                                    Indian CDSCO WC-0310A3-4
                                                                    Expired
                                                                    Dipyridamole USP/EP
                                                                    2022-05-27
                                                                    Application Number
                                                                    29020
                                                                    R0-CEP 2017-023 - Rev 01
                                                                    Indian CDSCO WC-0310A3-4
                                                                    Status
                                                                    Active
                                                                    Fees Unpaid
                                                                    Reviewed
                                                                    Valid
                                                                     
                                                                    Expired
                                                                    2023-11-23
                                                                    Filing Details
                                                                    DIPYRIDAMOLE USP
                                                                    Dipyridamole
                                                                    Dipyridamole USP/EP
                                                                    Issue/Submission Date
                                                                    2015-03-31
                                                                    2022-12-02
                                                                    2022-05-27
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                                                                      Lithium Carbonate

                                                                      PDF Supplier PDF
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                                                                      USDMF

                                                                      Found USDMF

                                                                      33629
                                                                      Active
                                                                      LITHIUM CARBONATE USP
                                                                      2019-03-19
                                                                      CEP/COS

                                                                      Found CEP/COS

                                                                      CEP 2023-190 - Rev 00
                                                                      Valid
                                                                      Lithium carbonate
                                                                      2024-01-11
                                                                      Japanese DMF

                                                                      Close JDMF

                                                                      Written Confirmation

                                                                      Caution WC

                                                                      Indian CDSCO WC-0310
                                                                      Expired
                                                                      Lithium Carbonate (USP)
                                                                      2021-01-08
                                                                      Application Number
                                                                      33629
                                                                      CEP 2023-190 - Rev 00
                                                                      Indian CDSCO WC-0310
                                                                      Status
                                                                      Active
                                                                      Fees Unpaid
                                                                      Reviewed
                                                                      Valid
                                                                       
                                                                      Expired
                                                                      2023-11-23
                                                                      Filing Details
                                                                      LITHIUM CARBONATE USP
                                                                      Lithium carbonate
                                                                      Lithium Carbonate (USP)
                                                                      Issue/Submission Date
                                                                      2019-03-19
                                                                      2024-01-11
                                                                      2021-01-08
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                                                                      US
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                                                                        Pirfenidone

                                                                        PDF Supplier PDF
                                                                        URL Supplier Web Content
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                                                                        See Less

                                                                        USDMF

                                                                        Found USDMF

                                                                        31072
                                                                        Active
                                                                        PIRFENIDONE
                                                                        2016-11-30
                                                                        CEP/COS

                                                                        Found CEP/COS

                                                                        R0-CEP 2017-170 - Rev 02
                                                                        Valid
                                                                        Pirfenidone
                                                                        2022-12-05
                                                                        Japanese DMF

                                                                        Close JDMF

                                                                        Written Confirmation

                                                                        Caution WC

                                                                        Indian CDSCO WC-0310
                                                                        Expired
                                                                        Pirfenidonee (Ph.Eur)
                                                                        2021-01-08
                                                                        Application Number
                                                                        31072
                                                                        R0-CEP 2017-170 - Rev 02
                                                                        Indian CDSCO WC-0310
                                                                        Status
                                                                        Active
                                                                        Fees Unpaid
                                                                        Reviewed
                                                                        Valid
                                                                         
                                                                        Expired
                                                                        2023-11-23
                                                                        Filing Details
                                                                        PIRFENIDONE
                                                                        Pirfenidone
                                                                        Pirfenidonee (Ph.Eur)
                                                                        Issue/Submission Date
                                                                        2016-11-30
                                                                        2022-12-05
                                                                        2021-01-08
                                                                        ASK
                                                                        US
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                                                                          Rosuvastatin Calcium

                                                                          PDF Supplier PDF
                                                                          URL Supplier Web Content
                                                                          See all info for this product

                                                                          See Less

                                                                          USDMF

                                                                          Found USDMF

                                                                          28888
                                                                          Active
                                                                          ROSUVASTATIN CALCIUM USP
                                                                          2015-01-12
                                                                          CEP/COS

                                                                          Found CEP/COS

                                                                          R0-CEP 2021-265 - Rev 01
                                                                          Valid
                                                                          Rosuvastatin calcium, D518 Process
                                                                          2022-12-05
                                                                          Japanese DMF

                                                                          Close JDMF

                                                                          Written Confirmation

                                                                          Caution WC

                                                                          Indian CDSCO WC-0310
                                                                          Expired
                                                                          Rosuvastatin Calcium IH
                                                                          2021-01-08
                                                                          Application Number
                                                                          28888
                                                                          R0-CEP 2021-265 - Rev 01
                                                                          Indian CDSCO WC-0310
                                                                          Status
                                                                          Active
                                                                          Fees Unpaid
                                                                          Reviewed
                                                                          Valid
                                                                           
                                                                          Expired
                                                                          2023-11-23
                                                                          Filing Details
                                                                          ROSUVASTATIN CALCIUM USP
                                                                          Rosuvastatin calcium, D518 Process
                                                                          Rosuvastatin Calcium IH
                                                                          Issue/Submission Date
                                                                          2015-01-12
                                                                          2022-12-05
                                                                          2021-01-08
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                                                                            Alfuzosin HCl

                                                                            PDF Supplier PDF
                                                                            URL Supplier Web Content
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                                                                            USDMF

                                                                            Found USDMF

                                                                            19675
                                                                            Active
                                                                            ALFUZOSIN HYDROCHLORIDE USP
                                                                            2006-08-10
                                                                            CEP/COS

                                                                            Close CEP/COS

                                                                            Japanese DMF

                                                                            Close JDMF

                                                                            Written Confirmation

                                                                            Found WC

                                                                            Indian CDSCO WC-0057n
                                                                            Valid
                                                                            Alfuzosin HCl Ph. Eur./USP/BP
                                                                            2022-06-07
                                                                            Application Number
                                                                            19675
                                                                            Indian CDSCO WC-0057n
                                                                            Status
                                                                            Active
                                                                            Fees Unpaid
                                                                            N/A
                                                                             
                                                                            Valid
                                                                            2025-06-25
                                                                            Filing Details
                                                                            ALFUZOSIN HYDROCHLORIDE USP
                                                                            Alfuzosin HCl Ph. Eur./USP/BP
                                                                            Issue/Submission Date
                                                                            2006-08-10
                                                                            2022-06-07
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                                                                              Aprepitant

                                                                              PDF Supplier PDF
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                                                                              USDMF

                                                                              Found USDMF

                                                                              20381
                                                                              Active
                                                                              APREPITANT USP
                                                                              2007-03-28
                                                                              CEP/COS

                                                                              Close CEP/COS

                                                                              Japanese DMF

                                                                              Close JDMF

                                                                              Written Confirmation

                                                                              Found WC

                                                                              Indian CDSCO WC-0057n
                                                                              Valid
                                                                              Aprepitant
                                                                              2022-06-07
                                                                              Application Number
                                                                              20381
                                                                              Indian CDSCO WC-0057n
                                                                              Status
                                                                              Active
                                                                              Fees Unpaid
                                                                              N/A
                                                                               
                                                                              Valid
                                                                              2025-06-25
                                                                              Filing Details
                                                                              APREPITANT USP
                                                                              Aprepitant
                                                                              Issue/Submission Date
                                                                              2007-03-28
                                                                              2022-06-07
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                                                                                Bupropion Hydrochloride

                                                                                PDF Supplier PDF
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                                                                                USDMF

                                                                                Found USDMF

                                                                                18163
                                                                                Active
                                                                                BUPROPION HYDROCHLORIDE USP
                                                                                2005-03-14
                                                                                CEP/COS

                                                                                Close CEP/COS

                                                                                Japanese DMF

                                                                                Close JDMF

                                                                                Written Confirmation

                                                                                Found WC

                                                                                Indian CDSCO WC-0057n
                                                                                Valid
                                                                                Bupropion hydrochloride USP
                                                                                2022-06-07
                                                                                Application Number
                                                                                18163
                                                                                Indian CDSCO WC-0057n
                                                                                Status
                                                                                Active
                                                                                Fees Unpaid
                                                                                Reviewed
                                                                                 
                                                                                Valid
                                                                                2025-06-25
                                                                                Filing Details
                                                                                BUPROPION HYDROCHLORIDE USP
                                                                                Bupropion hydrochloride USP
                                                                                Issue/Submission Date
                                                                                2005-03-14
                                                                                2022-06-07
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                                                                                  Cilostazol

                                                                                  PDF Supplier PDF
                                                                                  URL Supplier Web Content
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                                                                                  USDMF

                                                                                  Found USDMF

                                                                                  16876
                                                                                  Active
                                                                                  CILOSTAZOL USP
                                                                                  2003-10-02
                                                                                  CEP/COS

                                                                                  Close CEP/COS

                                                                                  Japanese DMF

                                                                                  Close JDMF

                                                                                  Written Confirmation

                                                                                  Found WC

                                                                                  Indian CDSCO WC-0057n
                                                                                  Valid
                                                                                  Cilostazol USP
                                                                                  2022-06-07
                                                                                  Application Number
                                                                                  16876
                                                                                  Indian CDSCO WC-0057n
                                                                                  Status
                                                                                  Active
                                                                                  Fees Unpaid
                                                                                  Reviewed
                                                                                   
                                                                                  Valid
                                                                                  2025-06-25
                                                                                  Filing Details
                                                                                  CILOSTAZOL USP
                                                                                  Cilostazol USP
                                                                                  Issue/Submission Date
                                                                                  2003-10-02
                                                                                  2022-06-07
                                                                                  ASK
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                                                                                    Darifenacin Hydrobromide

                                                                                    PDF Supplier PDF
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                                                                                    USDMF

                                                                                    Found USDMF

                                                                                    22184
                                                                                    Active
                                                                                    DARIFENACIN HYDROBROMIDE
                                                                                    2008-11-17
                                                                                    CEP/COS

                                                                                    Close CEP/COS

                                                                                    Japanese DMF

                                                                                    Close JDMF

                                                                                    Written Confirmation

                                                                                    Found WC

                                                                                    Indian CDSCO WC-0057n
                                                                                    Valid
                                                                                    Darifenacin Hydrobromide IH
                                                                                    2022-06-07
                                                                                    Application Number
                                                                                    22184
                                                                                    Indian CDSCO WC-0057n
                                                                                    Status
                                                                                    Active
                                                                                    Fees Unpaid
                                                                                    N/A
                                                                                     
                                                                                    Valid
                                                                                    2025-06-25
                                                                                    Filing Details
                                                                                    DARIFENACIN HYDROBROMIDE
                                                                                    Darifenacin Hydrobromide IH
                                                                                    Issue/Submission Date
                                                                                    2008-11-17
                                                                                    2022-06-07
                                                                                    ASK
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                                                                                    PHARMACOMPASS
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                                                                                      Frovatriptan Succinate Hydrate

                                                                                      PDF Supplier PDF
                                                                                      URL Supplier Web Content
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                                                                                      USDMF

                                                                                      Found USDMF

                                                                                      22952
                                                                                      Active
                                                                                      FROVATRIPTAN SUCCINATE MONOHYDRATE
                                                                                      2009-07-17
                                                                                      CEP/COS

                                                                                      Close CEP/COS

                                                                                      Japanese DMF

                                                                                      Close JDMF

                                                                                      Written Confirmation

                                                                                      Found WC

                                                                                      Indian CDSCO WC-0057n
                                                                                      Valid
                                                                                      Frovatriptan Succinate (1H)
                                                                                      2022-06-07
                                                                                      Application Number
                                                                                      22952
                                                                                      Indian CDSCO WC-0057n
                                                                                      Status
                                                                                      Active
                                                                                      Fees Unpaid
                                                                                      Reviewed
                                                                                       
                                                                                      Valid
                                                                                      2025-06-25
                                                                                      Filing Details
                                                                                      FROVATRIPTAN SUCCINATE MONOHYDRATE
                                                                                      Frovatriptan Succinate (1H)
                                                                                      Issue/Submission Date
                                                                                      2009-07-17
                                                                                      2022-06-07
                                                                                      ASK
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                                                                                        Imiquimod

                                                                                        PDF Supplier PDF
                                                                                        URL Supplier Web Content
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                                                                                        USDMF

                                                                                        Found USDMF

                                                                                        19735
                                                                                        Active
                                                                                        IMIQUIMOD USP
                                                                                        2006-09-06
                                                                                        CEP/COS

                                                                                        Close CEP/COS

                                                                                        Japanese DMF

                                                                                        Close JDMF

                                                                                        Written Confirmation

                                                                                        Found WC

                                                                                        Indian CDSCO WC-0057n
                                                                                        Valid
                                                                                        Imiquimod
                                                                                        2022-06-07
                                                                                        Application Number
                                                                                        19735
                                                                                        Indian CDSCO WC-0057n
                                                                                        Status
                                                                                        Active
                                                                                        Fees Unpaid
                                                                                        N/A
                                                                                         
                                                                                        Valid
                                                                                        2025-06-25
                                                                                        Filing Details
                                                                                        IMIQUIMOD USP
                                                                                        Imiquimod
                                                                                        Issue/Submission Date
                                                                                        2006-09-06
                                                                                        2022-06-07
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                                                                                          Itraconazole

                                                                                          PDF Supplier PDF
                                                                                          URL Supplier Web Content
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                                                                                          USDMF

                                                                                          Found USDMF

                                                                                          17946
                                                                                          Active
                                                                                          ITRACONAZOLE USP
                                                                                          2004-12-29
                                                                                          CEP/COS

                                                                                          Close CEP/COS

                                                                                          Japanese DMF

                                                                                          Close JDMF

                                                                                          Written Confirmation

                                                                                          Found WC

                                                                                          Indian CDSCO WC-0057n
                                                                                          Valid
                                                                                          Itraconazole (Ph.Eur.)
                                                                                          2022-06-07
                                                                                          Application Number
                                                                                          17946
                                                                                          Indian CDSCO WC-0057n
                                                                                          Status
                                                                                          Active
                                                                                          Fees Unpaid
                                                                                          N/A
                                                                                           
                                                                                          Valid
                                                                                          2025-06-25
                                                                                          Filing Details
                                                                                          ITRACONAZOLE USP
                                                                                          Itraconazole (Ph.Eur.)
                                                                                          Issue/Submission Date
                                                                                          2004-12-29
                                                                                          2022-06-07
                                                                                          ASK
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                                                                                          PHARMACOMPASS
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                                                                                            Levocetirizine Dihydrochloride

                                                                                            PDF Supplier PDF
                                                                                            URL Supplier Web Content
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                                                                                            USDMF

                                                                                            Found USDMF

                                                                                            22677
                                                                                            Active
                                                                                            LEVOCETIRIZINE DIHYDROCHLORIDE USP
                                                                                            2009-03-31
                                                                                            CEP/COS

                                                                                            Close CEP/COS

                                                                                            Japanese DMF

                                                                                            Close JDMF

                                                                                            Written Confirmation

                                                                                            Found WC

                                                                                            Indian CDSCO WC-0057n
                                                                                            Valid
                                                                                            Levocetrizine Dihydrochloride 
                                                                                            2022-06-07
                                                                                            Application Number
                                                                                            22677
                                                                                            Indian CDSCO WC-0057n
                                                                                            Status
                                                                                            Active
                                                                                            Fees Unpaid
                                                                                            N/A
                                                                                             
                                                                                            Valid
                                                                                            2025-06-25
                                                                                            Filing Details
                                                                                            LEVOCETIRIZINE DIHYDROCHLORIDE USP
                                                                                            Levocetrizine Dihydrochloride 
                                                                                            Issue/Submission Date
                                                                                            2009-03-31
                                                                                            2022-06-07
                                                                                            ASK
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                                                                                              Loratadine

                                                                                              PDF Supplier PDF
                                                                                              URL Supplier Web Content
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                                                                                              USDMF

                                                                                              Found USDMF

                                                                                              19400
                                                                                              Active
                                                                                              LORATADINE USP
                                                                                              2006-05-02
                                                                                              CEP/COS

                                                                                              Close CEP/COS

                                                                                              Japanese DMF

                                                                                              Close JDMF

                                                                                              Written Confirmation

                                                                                              Found WC

                                                                                              Indian CDSCO WC-0057n
                                                                                              Valid
                                                                                              Loratadine (Ph.Eur./USP/BP)
                                                                                              2022-06-07
                                                                                              Application Number
                                                                                              19400
                                                                                              Indian CDSCO WC-0057n
                                                                                              Status
                                                                                              Active
                                                                                              Fees Unpaid
                                                                                              N/A
                                                                                               
                                                                                              Valid
                                                                                              2025-06-25
                                                                                              Filing Details
                                                                                              LORATADINE USP
                                                                                              Loratadine (Ph.Eur./USP/BP)
                                                                                              Issue/Submission Date
                                                                                              2006-05-02
                                                                                              2022-06-07
                                                                                              ASK
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                                                                                                Moexipril

                                                                                                PDF Supplier PDF
                                                                                                URL Supplier Web Content
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                                                                                                USDMF

                                                                                                Found USDMF

                                                                                                20426
                                                                                                Active
                                                                                                MOEXIPRIL HYDROCHLORIDE USP
                                                                                                2007-04-09
                                                                                                CEP/COS

                                                                                                Close CEP/COS

                                                                                                Japanese DMF

                                                                                                Close JDMF

                                                                                                Written Confirmation

                                                                                                Found WC

                                                                                                Indian CDSCO WC-0057n
                                                                                                Valid
                                                                                                Moexipril Hydrochloride (1H)
                                                                                                2022-06-07
                                                                                                Application Number
                                                                                                20426
                                                                                                Indian CDSCO WC-0057n
                                                                                                Status
                                                                                                Active
                                                                                                Fees Unpaid
                                                                                                N/A
                                                                                                 
                                                                                                Valid
                                                                                                2025-06-25
                                                                                                Filing Details
                                                                                                MOEXIPRIL HYDROCHLORIDE USP
                                                                                                Moexipril Hydrochloride (1H)
                                                                                                Issue/Submission Date
                                                                                                2007-04-09
                                                                                                2022-06-07
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                                                                                                  Paliperidone

                                                                                                  PDF Supplier PDF
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                                                                                                  USDMF

                                                                                                  Found USDMF

                                                                                                  24163
                                                                                                  Active
                                                                                                  PALIPERIDONE
                                                                                                  2010-09-24
                                                                                                  CEP/COS

                                                                                                  Close CEP/COS

                                                                                                  Japanese DMF

                                                                                                  Close JDMF

                                                                                                  Written Confirmation

                                                                                                  Found WC

                                                                                                  Indian CDSCO WC-0057n
                                                                                                  Valid
                                                                                                  Paliperidone (IH)
                                                                                                  2022-06-07
                                                                                                  Application Number
                                                                                                  24163
                                                                                                  Indian CDSCO WC-0057n
                                                                                                  Status
                                                                                                  Active
                                                                                                  Fees Unpaid
                                                                                                  N/A
                                                                                                   
                                                                                                  Valid
                                                                                                  2025-06-25
                                                                                                  Filing Details
                                                                                                  PALIPERIDONE
                                                                                                  Paliperidone (IH)
                                                                                                  Issue/Submission Date
                                                                                                  2010-09-24
                                                                                                  2022-06-07
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                                                                                                    Riluzole

                                                                                                    PDF Supplier PDF
                                                                                                    URL Supplier Web Content
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                                                                                                    USDMF

                                                                                                    Found USDMF

                                                                                                    22107
                                                                                                    Active
                                                                                                    RILUZOLE USP
                                                                                                    2008-10-22
                                                                                                    CEP/COS

                                                                                                    Close CEP/COS

                                                                                                    Japanese DMF

                                                                                                    Close JDMF

                                                                                                    Written Confirmation

                                                                                                    Found WC

                                                                                                    Indian CDSCO WC-0057n
                                                                                                    Valid
                                                                                                    Riluzole USP
                                                                                                    2022-06-07
                                                                                                    Application Number
                                                                                                    22107
                                                                                                    Indian CDSCO WC-0057n
                                                                                                    Status
                                                                                                    Active
                                                                                                    Fees Unpaid
                                                                                                    N/A
                                                                                                     
                                                                                                    Valid
                                                                                                    2025-06-25
                                                                                                    Filing Details
                                                                                                    RILUZOLE USP
                                                                                                    Riluzole USP
                                                                                                    Issue/Submission Date
                                                                                                    2008-10-22
                                                                                                    2022-06-07
                                                                                                    ASK
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                                                                                                      Tazarotene

                                                                                                      PDF Supplier PDF
                                                                                                      URL Supplier Web Content
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                                                                                                      USDMF

                                                                                                      Found USDMF

                                                                                                      21422
                                                                                                      Active
                                                                                                      TAZAROTENE
                                                                                                      2008-03-14
                                                                                                      CEP/COS

                                                                                                      Close CEP/COS

                                                                                                      Japanese DMF

                                                                                                      Close JDMF

                                                                                                      Written Confirmation

                                                                                                      Found WC

                                                                                                      Indian CDSCO WC-0057n
                                                                                                      Valid
                                                                                                      Tazarotene
                                                                                                      2022-06-07
                                                                                                      Application Number
                                                                                                      21422
                                                                                                      Indian CDSCO WC-0057n
                                                                                                      Status
                                                                                                      Active
                                                                                                      Fees Unpaid
                                                                                                      Reviewed
                                                                                                       
                                                                                                      Valid
                                                                                                      2025-06-25
                                                                                                      Filing Details
                                                                                                      TAZAROTENE
                                                                                                      Tazarotene
                                                                                                      Issue/Submission Date
                                                                                                      2008-03-14
                                                                                                      2022-06-07
                                                                                                      ASK
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                                                                                                        Trandolapril

                                                                                                        PDF Supplier PDF
                                                                                                        URL Supplier Web Content
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                                                                                                        See Less

                                                                                                        USDMF

                                                                                                        Found USDMF

                                                                                                        18165
                                                                                                        Active
                                                                                                        TRANDOLAPRIL USP
                                                                                                        2005-03-14
                                                                                                        CEP/COS

                                                                                                        Close CEP/COS

                                                                                                        Japanese DMF

                                                                                                        Close JDMF

                                                                                                        Written Confirmation

                                                                                                        Found WC

                                                                                                        Indian CDSCO WC-0057n
                                                                                                        Valid
                                                                                                        Trandolapril Ph. Eur./USP/BP
                                                                                                        2022-06-07
                                                                                                        Application Number
                                                                                                        18165
                                                                                                        Indian CDSCO WC-0057n
                                                                                                        Status
                                                                                                        Active
                                                                                                        Fees Unpaid
                                                                                                        N/A
                                                                                                         
                                                                                                        Valid
                                                                                                        2025-06-25
                                                                                                        Filing Details
                                                                                                        TRANDOLAPRIL USP
                                                                                                        Trandolapril Ph. Eur./USP/BP
                                                                                                        Issue/Submission Date
                                                                                                        2005-03-14
                                                                                                        2022-06-07
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