01 1Apotex Fermentation Inc.
01 1BULK EVEROLIMUS
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-30
Pay. Date : 2016-10-24
DMF Number : 31073
Submission : 2016-10-27
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.
One of their notable products is BULK EVEROLIMUS, with a corresponding US DMF Number 31073.
Remarkably, this DMF maintains an Active status since its submission on October 27, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2017, and payment made on October 24, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
