01 1Apotex Pharmachem
01 1SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-01
Pay. Date : 2013-01-09
DMF Number : 24266
Submission : 2010-10-08
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 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP, with a corresponding US DMF Number 24266.
Remarkably, this DMF maintains an Active status since its submission on October 08, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 01, 2013, and payment made on January 09, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
