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 CEFTAZIDIME PENTAHYDRATE, STERILE, with a corresponding US DMF Number 20985.
Remarkably, this DMF maintains an Active status since its submission on October 31, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2014, and payment made on May 05, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II