01 1BrightGene Bio-Medical Technology Co.,Ltd
01 1SUGAMMADEX SODIUM (NON-STERILE, API)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-28
Pay. Date : 2019-07-01
DMF Number : 33904
Submission : 2019-06-06
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 SUGAMMADEX SODIUM (NON-STERILE, API), with a corresponding US DMF Number 33904.
Remarkably, this DMF maintains an Active status since its submission on June 06, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 28, 2019, and payment made on July 01, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
