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 UREA, with a corresponding US DMF Number 29874.
Remarkably, this DMF maintains an Active status since its submission on October 06, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 24, 2017, and payment made on July 26, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II