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    List of Drug Master Files (DMF) for 12472 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 METHOTREXATE SODIUM (1)

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    EXCELLA GMBH AND CO KG

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    Virtual BoothFareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
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    METHOTREXATE SODIUM

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    Other DMF ASMF
    12472
    Active
    1997-04-11
    Complete
    2018-11-26
    2018-11-16
    II
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    Looking for Drug Master Files (DMF) for 12472 of Excella Gmbh And Co Kg

    Looking for Drug Master Files (DMF) for 12472 of Excella Gmbh And Co Kg 1

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    Excella Gmbh And Co Kg, based in Luxembourg, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

    One of their notable products is METHOTREXATE SODIUM, with a corresponding US DMF Number 12472.

    Remarkably, this DMF maintains an Active status since its submission on April 11, 1997, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 26, 2018, and payment made on November 16, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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