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

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    01 Galactose (1)

    02 Hypromellose, Unspecified (2)

    03 L Methionine (1)

    04 L-Arginine Excipient (2)

    05 L-Histidine Excipient (2)

    06 Maltose Excipient (1)

    07 Mannitol (1)

    08 Sodium Succinate Hexahydrate (1)

    09 Trehalose (1)

    10 Trehalose Dihydrate (2)

    11 Tris HCl (1)

    12 Tromethamine (1)

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    01 Active (16)

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    01 Blank (16)

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    01 Blank (16)

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    01 Blank (16)

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    • FDA
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    Hypromellose, Unspecified

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    USDMF

    Found USDMF

    19538
    Active
    SUCROSE NF, EP, JP, ChP HIGH PURIT...
    2006-06-20
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    19538
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SUCROSE NF, EP, JP, ChP HIGH PURIT...
    Issue/Submission Date
    2006-06-20
    Pfanstiehl

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    Hypromellose, Unspecified

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    USDMF

    Found USDMF

    37676
    Active
    SUCROSE, NF, EP, JP, CHP HIGH PURIT...
    2022-11-11
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    37676
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SUCROSE, NF, EP, JP, CHP HIGH PURIT...
    Issue/Submission Date
    2022-11-11
    Pfanstiehl

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    L Methionine

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    USDMF

    Found USDMF

    38284
    Active
    L-METHIONINE, HIGH PURITY, LOW ENDO...
    2023-04-24
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    38284
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    L-METHIONINE, HIGH PURITY, LOW ENDO...
    Issue/Submission Date
    2023-04-24
    Pfanstiehl

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    L-Arginine Excipient

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    USDMF

    Found USDMF

    38012
    Active
    L-ARGININE, HIGH PURITY, LOW ENDOTO...
    2023-01-31
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    38012
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    L-ARGININE, HIGH PURITY, LOW ENDOTO...
    Issue/Submission Date
    2023-01-31
    Pfanstiehl

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    L-Arginine Excipient

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    USDMF

    Found USDMF

    38077
    Active
    L-ARGININE HYDROCHLORIDE, HIGH PURI...
    2023-02-17
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    38077
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    L-ARGININE HYDROCHLORIDE, HIGH PURI...
    Issue/Submission Date
    2023-02-17
    Pfanstiehl

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    Maltose Excipient

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    USDMF

    Found USDMF

    38161
    Active
    MALTOSE MONOHYDRATE, HIGH PURITY, L...
    2023-03-10
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    38161
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MALTOSE MONOHYDRATE, HIGH PURITY, L...
    Issue/Submission Date
    2023-03-10
    Pfanstiehl

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    Mannitol

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    USDMF

    Found USDMF

    32464
    Active
    D-MANNITOL (PLANT DERIVED) HIGH PUR...
    2018-02-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    32464
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    D-MANNITOL (PLANT DERIVED) HIGH PUR...
    Issue/Submission Date
    2018-02-15
    Pfanstiehl

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    • FDA
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    Trehalose

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    USDMF

    Found USDMF

    24122
    Active
    A, A-TREHALOSE DIHYDRATE, HIGH PURI...
    2010-08-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    24122
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    A, A-TREHALOSE DIHYDRATE, HIGH PURI...
    Issue/Submission Date
    2010-08-30
    Pfanstiehl

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    Trehalose Dihydrate

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    USDMF

    Found USDMF

    35182
    Active
    A, A TREHALOSE DIHYDRATE, INHALATIO...
    2020-09-09
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    35182
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    A, A TREHALOSE DIHYDRATE, INHALATIO...
    Issue/Submission Date
    2020-09-09
    Pfanstiehl

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    Trehalose Dihydrate

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    USDMF

    Found USDMF

    35277
    Active
    A, A TREHALOSE DIHYDRATE, HIGH PURI...
    2020-10-08
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    35277
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    A, A TREHALOSE DIHYDRATE, HIGH PURI...
    Issue/Submission Date
    2020-10-08
    Pfanstiehl

    DDF Summit, US

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