01 1Hangzhou Huadong Medicine Group Kangrun Pharmaceutical
01 1MIRABEGRON
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-26
Pay. Date : 2023-03-24
DMF Number : 37800
Submission : 2022-12-30
Status : Active
Type : II
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Zhejiang Huayi Pharmaceutical 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 MIRABEGRON, with a corresponding US DMF Number 37800.
Remarkably, this DMF maintains an Active status since its submission on December 30, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 26, 2023, and payment made on March 24, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
