01 1Amoli Organics
01 1MIRABEGRON
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-30
Pay. Date : 2023-09-22
DMF Number : 38825
Submission : 2023-09-15
Status : Active
Type : II
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Amoli Organics 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 MIRABEGRON, with a corresponding US DMF Number 38825.
Remarkably, this DMF maintains an Active status since its submission on September 15, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 30, 2023, and payment made on September 22, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
