01 1Zydus Lifesciences
01 1DARUNAVIR
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-19
Pay. Date : 2019-05-28
DMF Number : 33895
Submission : 2019-05-29
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 DARUNAVIR, with a corresponding US DMF Number 33895.
Remarkably, this DMF maintains an Active status since its submission on May 29, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 19, 2019, and payment made on May 28, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
