01 1Aurobindo Pharma Limited
01 1EZETIMIBE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-06
Pay. Date : 2016-08-10
DMF Number : 30801
Submission : 2016-08-17
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, with a corresponding US DMF Number 30801.
Remarkably, this DMF maintains an Active status since its submission on August 17, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 06, 2016, and payment made on August 10, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
