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Apotex Pharmachem 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 CYCLOSPORINE USP (BULK), with a corresponding US DMF Number 13929.
Remarkably, this DMF maintains an Active status since its submission on January 04, 1999, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 11, 2014, and payment made on May 08, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II