01 1Amoli Organics
01 1SACUBITRIL/VALSARTAN CRYSTALLINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-09
Pay. Date : 2025-09-03
DMF Number : 40981
Submission : 2024-12-19
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 SACUBITRIL/VALSARTAN CRYSTALLINE, with a corresponding US DMF Number 40981.
Remarkably, this DMF maintains an Active status since its submission on December 19, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 09, 2025, and payment made on September 03, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
