01 1Zydus Lifesciences
01 1VALSARTAN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-18
Pay. Date : 2020-11-12
DMF Number : 34826
Submission : 2020-04-30
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 VALSARTAN USP, with a corresponding US DMF Number 34826.
Remarkably, this DMF maintains an Active status since its submission on April 30, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 18, 2020, and payment made on November 12, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
