01 1BrightGene Bio-Medical Technology Co.,Ltd
01 1FONDAPARINUX SODIUM (NON-STERILE, API)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-06
Pay. Date : 2016-09-06
DMF Number : 30767
Submission : 2016-07-15
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 FONDAPARINUX SODIUM (NON-STERILE, API), with a corresponding US DMF Number 30767.
Remarkably, this DMF maintains an Active status since its submission on July 15, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 06, 2017, and payment made on September 06, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
