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    Cdymax
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    India
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    No. 77D & 116/117, KIADB Industrial Area, Jigani Bangalore-560105
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    +91- 8110 – 415545
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      Sunitinib

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      USDMF

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      36392
      Active
      SUNITINIB MALATE
      2021-10-12
      CEP/COS

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      Japanese DMF

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      305MF10101
      Sunitinib Malate at No. 77D & 116/1...
      2023-08-30
      Written Confirmation

      Found WC

      Indian CDSCO WC-0327n
      Valid
      Sunitinib Malate
      2021-09-01
      Application Number
      36392
      305MF10101
      Indian CDSCO WC-0327n
      Status
      Active
      Fees Unpaid
      Reviewed
       
      Valid
      2024-07-15
      Filing Details
      SUNITINIB MALATE
      Sunitinib Malate at No. 77D & 116/1...
      Sunitinib Malate
      Issue/Submission Date
      2021-10-12
      2023-08-30
      2021-09-01
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        Capecitabine

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        R1-CEP 2013-309 - Rev 03
        Valid
        Capecitabine
        2021-09-08
        Japanese DMF

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        Indian CDSCO WC-0327n
        Valid
        Capecitabin USP/EP/IP/IH
        2021-09-01
        Application Number
        R1-CEP 2013-309 - Rev 03
        Indian CDSCO WC-0327n
        Status
        Valid
         
        Valid
        2024-07-15
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        Capecitabine
        Capecitabin USP/EP/IP/IH
        Issue/Submission Date
        2021-09-08
        2021-09-01
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          Dasatinib

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          35990
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          DASATINIB [DRUG SUBSTANCE (NON-STER...
          2021-06-02
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          Indian CDSCO WC-0327n
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          Dasatinib IH
          2021-09-01
          Application Number
          35990
          Indian CDSCO WC-0327n
          Status
          Active
          Fees Unpaid
          Reviewed
           
          Valid
          2024-07-15
          Filing Details
          DASATINIB [DRUG SUBSTANCE (NON-STER...
          Dasatinib IH
          Issue/Submission Date
          2021-06-02
          2021-09-01
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            Erlotinib Hydrochloride

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            36007
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            ERLOTINIB HYDROCHLORIDE [DRUG SUBST...
            2021-06-04
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            Indian CDSCO WC-0327n
            Valid
            Erlotinib Hydrochloride IH
            2021-09-01
            Application Number
            36007
            Indian CDSCO WC-0327n
            Status
            Active
            Fees Unpaid
            Reviewed
             
            Valid
            2024-07-15
            Filing Details
            ERLOTINIB HYDROCHLORIDE [DRUG SUBST...
            Erlotinib Hydrochloride IH
            Issue/Submission Date
            2021-06-04
            2021-09-01
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              Imatinib Mesylate

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              CEP 2023-221 - Rev 00
              Valid
              Imatinib mesilate, Process 2
              2023-10-30
              Japanese DMF

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              Indian CDSCO WC-0327n
              Valid
              Imatinib Mesilate IH
              2021-09-01
              Application Number
              CEP 2023-221 - Rev 00
              Indian CDSCO WC-0327n
              Status
              Valid
               
              Valid
              2024-07-15
              Filing Details
              Imatinib mesilate, Process 2
              Imatinib Mesilate IH
              Issue/Submission Date
              2023-10-30
              2021-09-01
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                Pazopanib Hydrochloride

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                USDMF

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                33054
                Active
                PAZOPANIB HCL (NON-STERILE DRUG SUB...
                2018-07-28
                CEP/COS

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                Indian CDSCO WC-0327n
                Valid
                Pazopanib HCl IH
                2021-09-01
                Application Number
                33054
                Indian CDSCO WC-0327n
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Valid
                2024-07-15
                Filing Details
                PAZOPANIB HCL (NON-STERILE DRUG SUB...
                Pazopanib HCl IH
                Issue/Submission Date
                2018-07-28
                2021-09-01
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                  Abacavir

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                  Indian CDSCO WC-0327n
                  Valid
                  Abacavir IH
                  2021-09-01
                  Application Number
                  Indian CDSCO WC-0327n
                  Status
                   
                  Valid
                  2024-07-15
                  Filing Details
                  Abacavir IH
                  Issue/Submission Date
                  2021-09-01
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                    Abiraterone Acetate

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                    36670
                    Active
                    ABIRATERONE ACETATE
                    2022-01-06
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                    Application Number
                    36670
                    Status
                    Active
                    Fees Unpaid
                    N/A
                     
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                    ABIRATERONE ACETATE
                    Issue/Submission Date
                    2022-01-06
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                      Dasatinib

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                      USDMF

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                      37942
                      Active
                      DASATINIB
                      2023-01-16
                      CEP/COS

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                      Application Number
                      37942
                      Status
                      Active
                      Fees Unpaid
                      Reviewed
                       
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                      DASATINIB
                      Issue/Submission Date
                      2023-01-16
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                        Enzalutamide

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                        USDMF

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                        37904
                        Active
                        ENZALUTAMIDE
                        2022-12-22
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                        Japanese DMF

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                        Application Number
                        37904
                        Status
                        Active
                        Fees Unpaid
                        N/A
                         
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                        ENZALUTAMIDE
                        Issue/Submission Date
                        2022-12-22
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                          Imatinib Mesylate

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                          CEP/COS

                          Found CEP/COS

                          R0-CEP 2018-262 - Rev 01
                          Valid
                          Imatinib mesilate
                          2022-10-24
                          Japanese DMF

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                          Written Confirmation

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                          Application Number
                          R0-CEP 2018-262 - Rev 01
                          Status
                          Valid
                           
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                          Imatinib mesilate
                          Issue/Submission Date
                          2022-10-24
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                            Palbociclib

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                            USDMF

                            Found USDMF

                            33055
                            Active
                            PALBOCICLIB (NON-STERILE DRUG SUBST...
                            2018-08-14
                            CEP/COS

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                            Japanese DMF

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                            Application Number
                            33055
                            Status
                            Active
                            Fees Unpaid
                            Reviewed
                             
                            Filing Details
                            PALBOCICLIB (NON-STERILE DRUG SUBST...
                            Issue/Submission Date
                            2018-08-14
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                              Abacavir Sulfate

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                              USDMF

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                              CEP/COS

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                              Written Confirmation

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                                Alectinib Hydrochloride

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                                USDMF

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                                CEP/COS

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                                  Atazanavir Sulfate

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                                  USDMF

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                                    Bictegravir

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                                      Dabigatran Etexilate Mesylate

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                                        Daclatasvir

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                                          Elagolix Sodium

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                                            Eltrombopag

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                                              Erlotinib

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                                                Gefitinib

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                                                  Ibrutinib

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                                                    Isavuconazonium Sulfate

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                                                      Nilotinib

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                                                        Olaparib

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                                                          Oseltamivir Phosphate

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                                                            Pemetrexed Disodium

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                                                                Ruxolitinib Phosphate

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                                                                  Sorafenib

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                                                                    Tenofovir Alafenamide Fumarate

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