01 1BrightGene Bio-Medical Technology Co.,Ltd
01 1ISAVUCONAZONIUM SULFATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-25
Pay. Date : 2024-03-07
DMF Number : 38502
Submission : 2023-10-19
Status : Active
Type : II
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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 ISAVUCONAZONIUM SULFATE, with a corresponding US DMF Number 38502.
Remarkably, this DMF maintains an Active status since its submission on October 19, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 25, 2024, and payment made on March 07, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
