01 1Amoli Organics
01 1SITAGLIPTIN PHOSPHATE MONOHYDRATE USP PROCESS-II
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-11-12
Pay. Date : 2025-09-19
DMF Number : 42568
Submission : 2025-09-11
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 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP PROCESS-II, with a corresponding US DMF Number 42568.
Remarkably, this DMF maintains an Active status since its submission on September 11, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 12, 2025, and payment made on September 19, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
