01 1Amoli Organics
01 1RIVAROXABAN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-17
Pay. Date : 2023-03-24
DMF Number : 38122
Submission : 2023-03-04
Status : Active
Type : II
20
Amoli Organics (a Division Of Umedica Laboratories Pvt 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 RIVAROXABAN USP, with a corresponding US DMF Number 38122.
Remarkably, this DMF maintains an Active status since its submission on March 04, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 17, 2023, and payment made on March 24, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
