Brightgene Bio-medical Technology Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is EVEROLIMUS (0.2%BHT), with a corresponding US DMF Number 36661.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 08, 2023, and payment made on July 19, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II