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    List of Drug Master Files (DMF) for 31282 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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    Alembic Pharmaceuticals Limited

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    Boulder Peptide 2024
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    Alembic Pharmaceuticals Ltd

    India
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    Boulder Peptide 2024
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-04-18

    Pay. Date : 2017-03-27

    DMF Number : 31282

    Submission : 2017-03-31

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 31282 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 31282 of Alembic Pharmaceuticals Ltd 1

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    Alembic Pharmaceuticals 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 DASATINIB, with a corresponding US DMF Number 31282.

    Remarkably, this DMF maintains an Active status since its submission on March 31, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 18, 2017, and payment made on March 27, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II