01 1Apotex Pharmachem
01 1POSACONAZOLE
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-21
Pay. Date : 2016-07-20
DMF Number : 30343
Submission : 2016-03-31
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 POSACONAZOLE, with a corresponding US DMF Number 30343.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 21, 2016, and payment made on July 20, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
