01 1BrightGene Bio-Medical Technology Co.,Ltd
01 1MICAFUNGIN SODIUM (NON-STERILE, API)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-03
Pay. Date : 2017-04-06
DMF Number : 31449
Submission : 2017-03-03
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 MICAFUNGIN SODIUM (NON-STERILE, API), with a corresponding US DMF Number 31449.
Remarkably, this DMF maintains an Active status since its submission on March 03, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 03, 2017, and payment made on April 06, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
