01 1Zydus Lifesciences
01 1DABIGATRAN ETEXILATE MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-24
Pay. Date : 2014-05-19
DMF Number : 28285
Submission : 2014-05-29
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 DABIGATRAN ETEXILATE MESYLATE, with a corresponding US DMF Number 28285.
Remarkably, this DMF maintains an Active status since its submission on May 29, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 24, 2014, and payment made on May 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
