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

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    01 Phenylephrine Hydrochloride (1)

    02 Pilocarpine Hydrochloride (1)

    03 Terbinafine Hydrochloride (1)

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    01 Valid (2)

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    01 303MF10062 (1)

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      Phenylephrine Hydrochloride

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      USDMF

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      CEP/COS

      Found CEP/COS

      R1-CEP 2000-016 - Rev 02
      Valid
      Phenylephrine hydrochloride
      2021-08-06
      Japanese DMF

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      Application Number
      R1-CEP 2000-016 - Rev 02
      Status
      Valid
       
      Filing Details
      Phenylephrine hydrochloride
      Issue/Submission Date
      2021-08-06
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        Pilocarpine Hydrochloride

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        USDMF

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        CEP/COS

        Found CEP/COS

        R0-CEP 2015-343 - Rev 01
        Valid
        Pilocarpine hydrochloride
        2021-08-06
        Japanese DMF

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        Written Confirmation

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        Application Number
        R0-CEP 2015-343 - Rev 01
        Status
        Valid
         
        Filing Details
        Pilocarpine hydrochloride
        Issue/Submission Date
        2021-08-06
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          Terbinafine Hydrochloride

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          USDMF

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          CEP/COS

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          Japanese DMF

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          303MF10062
          Terbinafine Hydrochloride at 4-8-2 ...
          2021-04-08
          Written Confirmation

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          Application Number
          303MF10062
          Status
           
          Filing Details
          Terbinafine Hydrochloride at 4-8-2 ...
          Issue/Submission Date
          2021-04-08
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