01 1Zydus Lifesciences
01 1LUMATEPERONE TOSYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-18
Pay. Date : 2023-09-21
DMF Number : 38778
Submission : 2023-09-21
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 LUMATEPERONE TOSYLATE, with a corresponding US DMF Number 38778.
Remarkably, this DMF maintains an Active status since its submission on September 21, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2023, and payment made on September 21, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
