01 1Aurobindo Pharma Limited
01 1QUETIAPINE FUMARATE USP (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-12
Pay. Date : 2022-12-22
DMF Number : 37881
Submission : 2022-12-23
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 QUETIAPINE FUMARATE USP (PROCESS II), with a corresponding US DMF Number 37881.
Remarkably, this DMF maintains an Active status since its submission on December 23, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 12, 2023, and payment made on December 22, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
