01 1Laurus Labs
01 1TENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-2)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-18
Pay. Date : 2021-11-18
DMF Number : 36443
Submission : 2021-12-22
Status : Active
Type : II
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Laurus Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is TENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-2), with a corresponding US DMF Number 36443.
Remarkably, this DMF maintains an Active status since its submission on December 22, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2022, and payment made on November 18, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
