01 1Zydus Lifesciences
01 1DIROXIMEL FUMARATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-28
Pay. Date : 2023-02-15
DMF Number : 35373
Submission : 2020-11-26
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 DIROXIMEL FUMARATE, with a corresponding US DMF Number 35373.
Remarkably, this DMF maintains an Active status since its submission on November 26, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 28, 2023, and payment made on February 15, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
