01 1Zydus Lifesciences
01 1FESOTERODINE FUMARATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-29
Pay. Date : 2012-11-09
DMF Number : 25916
Submission : 2012-05-17
Status : Active
Type : II
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Zydus Lifesciences 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 FESOTERODINE FUMARATE, with a corresponding US DMF Number 25916.
Remarkably, this DMF maintains an Active status since its submission on May 17, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 29, 2013, and payment made on November 09, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
