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    List of Drug Master Files (DMF) for 17227 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Bachem AG

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    01 Bachem AG (1)

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    01 EXENATIDE (BULK) (1)

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    BACHEM AMERICAS INC

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    • FDA
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    Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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    EXENATIDE (BULK)

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    17227
    Active
    2004-03-05
    Complete
    2014-03-21
    2013-09-16
    II
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    Looking for Drug Master Files (DMF) for 17227 of Bachem Americas Inc

    Looking for Drug Master Files (DMF) for 17227 of Bachem Americas Inc 1

    20

    Bachem Americas Inc, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

    One of their notable products is EXENATIDE (BULK), with a corresponding US DMF Number 17227.

    Remarkably, this DMF maintains an Active status since its submission on March 05, 2004, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 21, 2014, and payment made on September 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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