01 1Emcure Pharmaceuticals
01 1DECITABINE MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-13
Pay. Date : 2014-01-22
DMF Number : 26948
Submission : 2013-03-29
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 DECITABINE MONOHYDRATE, with a corresponding US DMF Number 26948.
Remarkably, this DMF maintains an Active status since its submission on March 29, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 13, 2014, and payment made on January 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
