01 1Aurobindo Pharma Limited
01 1MIRTAZAPINE USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-08-19
Pay. Date : 2025-07-09
DMF Number : 41329
Submission : 2025-03-03
Status : Active
Type : II
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Apitoria Pharma Private 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 MIRTAZAPINE USP (PROCESS-II), with a corresponding US DMF Number 41329.
Remarkably, this DMF maintains an Active status since its submission on March 03, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 19, 2025, and payment made on July 09, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
