01 1Aurobindo Pharma Limited
01 1DABIGATRAN ETEXILATE MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-23
Pay. Date : 2014-07-11
DMF Number : 28442
Submission : 2014-07-15
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 DABIGATRAN ETEXILATE MESYLATE, with a corresponding US DMF Number 28442.
Remarkably, this DMF maintains an Active status since its submission on July 15, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 23, 2014, and payment made on July 11, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
