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    List of Drug Master Files (DMF) for 12634 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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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    DOXAZOSIN MESYLATE

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    12634
    Active
    1997-08-27
    Complete
    2013-04-15
    2013-01-08
    II
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    Looking for Drug Master Files (DMF) for 12634 of Excella Gmbh And Co Kg

    Looking for Drug Master Files (DMF) for 12634 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 DOXAZOSIN MESYLATE, with a corresponding US DMF Number 12634.

    Remarkably, this DMF maintains an Active status since its submission on August 27, 1997, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 15, 2013, and payment made on January 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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