01 1Zydus Lifesciences
01 1BRIVARACETAM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-23
Pay. Date : 2020-02-18
DMF Number : 34405
Submission : 2019-12-31
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 BRIVARACETAM, with a corresponding US DMF Number 34405.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 23, 2020, and payment made on February 18, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
