01 1Emcure Pharmaceuticals
01 1MEMANTINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-04
Pay. Date : 2013-01-11
DMF Number : 25321
Submission : 2011-10-22
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 MEMANTINE HYDROCHLORIDE USP, with a corresponding US DMF Number 25321.
Remarkably, this DMF maintains an Active status since its submission on October 22, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 04, 2013, and payment made on January 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
