01 1Emcure Pharmaceuticals
01 1ZILEUTON USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-09
Pay. Date : 2016-10-17
DMF Number : 25805
Submission : 2012-03-26
Status : Active
Type : II
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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 ZILEUTON USP, with a corresponding US DMF Number 25805.
Remarkably, this DMF maintains an Active status since its submission on March 26, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 09, 2016, and payment made on October 17, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
