01 1Emcure Pharmaceuticals
01 1GEMCITABINE HYDROCHLORIDE USP (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-05
Pay. Date : 2014-12-10
DMF Number : 27617
Submission : 2013-10-25
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 GEMCITABINE HYDROCHLORIDE USP (PROCESS II), with a corresponding US DMF Number 27617.
Remarkably, this DMF maintains an Active status since its submission on October 25, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 05, 2015, and payment made on December 10, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
