01 1Amoli Organics
01 1APIXABAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-26
Pay. Date : 2023-09-28
DMF Number : 38900
Submission : 2023-09-23
Status : Active
Type : II
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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 APIXABAN, with a corresponding US DMF Number 38900.
Remarkably, this DMF maintains an Active status since its submission on September 23, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 26, 2023, and payment made on September 28, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
