01 1BrightGene Bio-Medical Technology Co.,Ltd
01 1EVEROLIMUS (NON-STERILE API)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-01
Pay. Date : 2020-09-21
DMF Number : 32020
Submission : 2017-09-20
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 EVEROLIMUS (NON-STERILE API), with a corresponding US DMF Number 32020.
Remarkably, this DMF maintains an Active status since its submission on September 20, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 01, 2020, and payment made on September 21, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
