Merck Kgaa, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is MEGLUMINE, with a corresponding US DMF Number 3413.
Remarkably, this DMF maintains an Active status since its submission on October 17, 1978, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 10, 2016, and payment made on September 30, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II