01 1Apotex Pharmachem
01 1RIVAROXABAN
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-13
Pay. Date : 2014-12-30
DMF Number : 28922
Submission : 2014-12-31
Status : Active
Type : II
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Apotex Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is RIVAROXABAN, with a corresponding US DMF Number 28922.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 13, 2015, and payment made on December 30, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
