01 1Amoli Organics
01 1VARENICLINE TARTRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-08-12
Pay. Date : 2025-07-10
DMF Number : 38471
Submission : 2023-06-22
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 VARENICLINE TARTRATE, with a corresponding US DMF Number 38471.
Remarkably, this DMF maintains an Active status since its submission on June 22, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 12, 2025, and payment made on July 10, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
