01 1Emcure Pharmaceuticals
01 1LEFLUNOMIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-24
Pay. Date : 2025-07-18
DMF Number : 16124
Submission : 2002-09-06
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 LEFLUNOMIDE USP, with a corresponding US DMF Number 16124.
Remarkably, this DMF maintains an Active status since its submission on September 06, 2002, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 24, 2025, and payment made on July 18, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
