Fresenius Kabi Ipsum Srl, based in Sweden, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is BUFFERED NAFCILLIN SODIUM STERILE, with a corresponding US DMF Number 25387.
Remarkably, this DMF maintains an Active status since its submission on September 01, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 03, 2014, and payment made on December 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II