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    List of Drug Master Files (DMF) for 31490 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Glenmark Life Sciences

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      APREMILAST

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      31490
      Active
      2017-03-31
      Complete
      2017-05-25
      2017-04-03
      II
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      Looking for Drug Master Files (DMF) for 31490 of Glenmark Life Sciences Ltd

      Looking for Drug Master Files (DMF) for 31490 of Glenmark Life Sciences Ltd 1

      20

      Glenmark Life Sciences Ltd, based in India, is a pharmaceutical company.

      One of their notable products is APREMILAST, with a corresponding US DMF Number 31490.

      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 May 25, 2017, and payment made on April 03, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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