01 1Apotex Pharmachem
01 1SELEXIPAG
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-06
Pay. Date : 2019-05-23
DMF Number : 33828
Submission : 2019-05-31
Status : Active
Type : II
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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 SELEXIPAG, with a corresponding US DMF Number 33828.
Remarkably, this DMF maintains an Active status since its submission on May 31, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 06, 2019, and payment made on May 23, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
