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List of Drug Master Files (DMF) for 15364 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 1Divis Laboratories

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Boulder Peptide 2024
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Looking for Drug Master Files (DMF) for 15364 of Divis Laboratories Ltd

Looking for Drug Master Files (DMF) for 15364 of Divis Laboratories Ltd 1

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Divis 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 NABUMETONE USP, with a corresponding US DMF Number 15364.

Remarkably, this DMF maintains an Active status since its submission on April 02, 2001, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2016, and payment made on December 23, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II