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List of Drug Master Files (DMF) for 26815 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Emcure Pharmaceuticals (1)

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01 FEBUXOSTAT (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
26815
Active
2013-02-01
Complete
2014-02-03
2013-06-24
II
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Looking for Drug Master Files (DMF) for 26815 of Emcure Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 26815 of Emcure Pharmaceuticals Ltd 1

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Emcure 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 FEBUXOSTAT, with a corresponding US DMF Number 26815.

Remarkably, this DMF maintains an Active status since its submission on February 01, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 03, 2014, and payment made on June 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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