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 TESTOSTERONE ENANTHATE, with a corresponding US DMF Number 3391.
Remarkably, this DMF maintains an Active status since its submission on October 31, 1978, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2015, and payment made on August 26, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II