01 1BrightGene Bio-Medical Technology Co.,Ltd
01 1POSACONAZOLE CRYSTALLINE III
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-15
Pay. Date : 2016-09-19
DMF Number : 30886
Submission : 2016-09-30
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 POSACONAZOLE CRYSTALLINE III, with a corresponding US DMF Number 30886.
Remarkably, this DMF maintains an Active status since its submission on September 30, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2016, and payment made on September 19, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
