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    List of Drug Master Files (DMF) for 13867 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Boulder Peptide 2024
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    Divis Laboratories Ltd

    India
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-08-07

    Pay. Date : 2013-07-26

    DMF Number : 13867

    Submission : 1998-11-27

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 13867 of Divis Laboratories Ltd

    Looking for Drug Master Files (DMF) for 13867 of Divis Laboratories Ltd 1

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    Divis Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is NAPROXEN SODIUM USP, with a corresponding US DMF Number 13867.

    Remarkably, this DMF maintains an Active status since its submission on November 27, 1998, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 07, 2013, and payment made on July 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II