01 1Apotex Pharmachem
01 1TASIMELTEON
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-30
Pay. Date : 2017-07-26
DMF Number : 31843
Submission : 2017-07-31
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 TASIMELTEON, with a corresponding US DMF Number 31843.
Remarkably, this DMF maintains an Active status since its submission on July 31, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 30, 2017, and payment made on July 26, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
