01 1Aurobindo Pharma Limited
01 1DRONEDARONE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-12-29
DMF Number : 31265
Submission : 2016-12-30
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 DRONEDARONE HYDROCHLORIDE USP, with a corresponding US DMF Number 31265.
Remarkably, this DMF maintains an Active status since its submission on December 30, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 27, 2017, and payment made on December 29, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
