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    List of Drug Master Files (DMF) for 31435 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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    Alkem Laboratories Ltd

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-08-18

    Pay. Date : 2017-03-30

    DMF Number : 31435

    Submission : 2017-03-27

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 31435 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 31435 of Alkem Laboratories Ltd 1

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    Alkem 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 TAPENTADOL HYDROCHLORIDE, with a corresponding US DMF Number 31435.

    Remarkably, this DMF maintains an Active status since its submission on March 27, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 18, 2017, and payment made on March 30, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II