01 1Apotex Pharmachem
01 1PERINDOPRIL ARGININE
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-18
Pay. Date : 2016-08-24
DMF Number : 30810
Submission : 2016-08-30
Status : Active
Type : II
20
Apotex Pharmachem India Pvt Ltd, 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 PERINDOPRIL ARGININE, with a corresponding US DMF Number 30810.
Remarkably, this DMF maintains an Active status since its submission on August 30, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 18, 2016, and payment made on August 24, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
