01 1Zydus Lifesciences
01 1OSELTAMIVIR PHOSPHATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-08-22
Pay. Date : 2025-07-24
DMF Number : 37677
Submission : 2022-11-24
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 OSELTAMIVIR PHOSPHATE USP, with a corresponding US DMF Number 37677.
Remarkably, this DMF maintains an Active status since its submission on November 24, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 22, 2025, and payment made on July 24, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
