01 1BrightGene Bio-Medical Technology Co.,Ltd
01 1ERIBULIN MESYLATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-08
Pay. Date : 2020-11-06
DMF Number : 35118
Submission : 2020-10-28
Status : Active
Type : II
20
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 ERIBULIN MESYLATE, with a corresponding US DMF Number 35118.
Remarkably, this DMF maintains an Active status since its submission on October 28, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 08, 2021, and payment made on November 06, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
