01 1Aurobindo Pharma Limited
01 1EZETIMIBE USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-01
Pay. Date : 2022-07-26
DMF Number : 37368
Submission : 2022-07-28
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 EZETIMIBE USP (PROCESS-II), with a corresponding US DMF Number 37368.
Remarkably, this DMF maintains an Active status since its submission on July 28, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 01, 2022, and payment made on July 26, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
