01 1BrightGene Bio-Medical Technology Co.,Ltd
01 1DALBAVANCIN HYDROCHLORIDE (DB)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-18
Pay. Date : 2022-12-12
DMF Number : 37186
Submission : 2022-11-24
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 DALBAVANCIN HYDROCHLORIDE (DB), with a corresponding US DMF Number 37186.
Remarkably, this DMF maintains an Active status since its submission on November 24, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2023, and payment made on December 12, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
