01 1Emcure Pharmaceuticals
01 1ESOMEPRAZOLE SODIUM (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-09
Pay. Date : 2013-08-19
DMF Number : 27388
Submission : 2013-08-22
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 ESOMEPRAZOLE SODIUM (PROCESS II), with a corresponding US DMF Number 27388.
Remarkably, this DMF maintains an Active status since its submission on August 22, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 09, 2013, and payment made on August 19, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
