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    List of Drug Master Files (DMF) for 31651 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    FAMAR CDMO- From early development to commercial manufacturing.

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Ajinomoto Company

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    BioProcess International
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    Ajinomoto Co Inc

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-08-27

    Pay. Date : 2020-11-30

    DMF Number : 31651

    Submission : 2017-04-20

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 31651 of Ajinomoto Co Inc

    Looking for Drug Master Files (DMF) for 31651 of Ajinomoto Co Inc 1

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    Ajinomoto Co Inc, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is L-LYSINE MONOHYDROCHLORIDE, with a corresponding US DMF Number 31651.

    Remarkably, this DMF maintains an Active status since its submission on April 20, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 27, 2021, and payment made on November 30, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II