01 1Amoli Organics
01 1SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-01
Pay. Date : 2022-05-11
DMF Number : 36930
Submission : 2022-03-29
Status : Active
Type : II
20
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, with a corresponding US DMF Number 36930.
Remarkably, this DMF maintains an Active status since its submission on March 29, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 01, 2022, and payment made on May 11, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
