01 1Amoli Organics
01 1DAPAGLIFLOZIN AMORPHOUS PROCESS-II
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-10-24
Pay. Date : 2025-09-17
DMF Number : 42486
Submission : 2025-08-30
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 DAPAGLIFLOZIN AMORPHOUS PROCESS-II, with a corresponding US DMF Number 42486.
Remarkably, this DMF maintains an Active status since its submission on August 30, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2025, and payment made on September 17, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
