01 1Apotex Pharmachem
01 1PALBOCICLIB
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-29
Pay. Date : 2018-07-06
DMF Number : 32907
Submission : 2018-07-25
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 PALBOCICLIB, with a corresponding US DMF Number 32907.
Remarkably, this DMF maintains an Active status since its submission on July 25, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 29, 2018, and payment made on July 06, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
