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    List of Drug Master Files (DMF) for 21196 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 Fareva (1)

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    01 BUPIVACAINE HYDROCHLORIDE (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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    BUPIVACAINE HYDROCHLORIDE

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    21196
    Active
    2007-12-20
    Complete
    2017-03-31
    2016-05-04
    II
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    Looking for Drug Master Files (DMF) for 21196 of Excella Gmbh And Co Kg

    Looking for Drug Master Files (DMF) for 21196 of Excella Gmbh And Co Kg 1

    20

    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 BUPIVACAINE HYDROCHLORIDE, with a corresponding US DMF Number 21196.

    Remarkably, this DMF maintains an Active status since its submission on December 20, 2007, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2017, and payment made on May 04, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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