Bayer Ag, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ETHINYLESTRADIOL, with a corresponding US DMF Number 1985.
Remarkably, this DMF maintains an Active status since its submission on August 16, 1972, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 11, 2013, and payment made on July 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II