01 1Hubei Gedian Humanwell Pharmaceutical
01 1MIRABEGRON
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-03
Pay. Date : 2023-08-23
DMF Number : 38156
Submission : 2023-03-24
Status : Active
Type : II
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Hubei Gedian Humanwell Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
One of their notable products is MIRABEGRON, with a corresponding US DMF Number 38156.
Remarkably, this DMF maintains an Active status since its submission on March 24, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 03, 2023, and payment made on August 23, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
