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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Pfanstiehl to the U.S. FDA. Original Data : FDA Website

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    01 A, A-TREHALOSE DIHYDRATE, API (1)

    02 AMMONIUM LACTATE (1)

    03 METHOTREXATE, HIGH PURITY LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, ChP (M-166-1) (1)

    04 PODOPHYLLOTOXIN (P-126) (1)

    05 SODIUM DL-LACTATE SOLUTION 60%, USP (S-110, S110-M) (1)

    06 SODIUM GLUCONATE, USP (S-108) (1)

    07 STREPTOZOTOCIN (S-119) (1)

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    01 PFANSTIEHL INC (7)

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    01 U.S.A (7)

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    01 Active (7)

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    01 Complete (1)

    02 Blank (6)

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    • FDA
    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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    A, A-TREHALOSE DIHYDRATE, API

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    Other DMF CN
    PFANSTIEHL INC
    Active
    33548
    N/A
    2019-02-28
    II
    Pfanstiehl

    DDF Summit, US

    Attending

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    • FDA
    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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    AMMONIUM LACTATE

    PDF Supplier PDF
    URL Supplier Web Content
    PFANSTIEHL INC
    Active
    12612
    N/A
    1997-08-05
    II
    Pfanstiehl

    DDF Summit, US

    Attending

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    • FDA
    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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    METHOTREXATE, HIGH PURITY LOW ENDOT...

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    URL Supplier Web Content
    PFANSTIEHL INC
    Active
    39988
    N/A
    2024-06-05
    II
    Pfanstiehl

    DDF Summit, US

    Attending

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    • FDA
    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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    PODOPHYLLOTOXIN (P-126)

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    URL Supplier Web Content
    PFANSTIEHL INC
    Active
    25758
    N/A
    2012-02-03
    II
    Pfanstiehl

    DDF Summit, US

    Attending

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    • FDA
    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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    SODIUM DL-LACTATE SOLUTION 60%, USP...

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    PFANSTIEHL INC
    Active
    7658
    N/A
    1988-09-06
    II
    Pfanstiehl

    DDF Summit, US

    Attending

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    • FDA
    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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    SODIUM GLUCONATE, USP (S-108)

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    PFANSTIEHL INC
    Active
    9147
    Complete
    2021-09-14
    2021-09-09
    1991-05-31
    II
    Pfanstiehl

    DDF Summit, US

    Attending

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    • FDA
    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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    STREPTOZOTOCIN (S-119)

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    PFANSTIEHL INC
    Active
    2614
    N/A
    1976-02-17
    II
    Pfanstiehl

    DDF Summit, US

    Attending

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