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    List of Drug Master Files (DMF) for 29703 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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

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    AMLODIPINE BESYLATE USP

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    29703
    Active
    2015-09-28
    Complete
    2016-03-03
    2015-10-06
    II
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    Looking for Drug Master Files (DMF) for 29703 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 29703 of Alkem Laboratories Ltd 1

    20

    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 AMLODIPINE BESYLATE USP, with a corresponding US DMF Number 29703.

    Remarkably, this DMF maintains an Active status since its submission on September 28, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2016, and payment made on October 06, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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