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    List of Drug Master Files (DMF) for 28262 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Biophore India Pharmaceuticals Pvt L...

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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-03-12

    Pay. Date : 2014-12-24

    DMF Number : 28262

    Submission : 2014-06-23

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 28262 of Biophore India Pharmaceuticals Pvt Ltd

    Looking for Drug Master Files (DMF) for 28262 of Biophore India Pharmaceuticals Pvt Ltd 1

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    Biophore India Pharmaceuticals Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from EDQM.

    They are recognized for Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    One of their notable products is NILUTAMIDE, with a corresponding US DMF Number 28262.

    Remarkably, this DMF maintains an Active status since its submission on June 23, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 12, 2015, and payment made on December 24, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II