01 1Hubei Gedian Humanwell Pharmaceutical
01 1DIENOGEST
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-24
Pay. Date : 2025-07-10
DMF Number : 37957
Submission : 2023-01-18
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 DIENOGEST, with a corresponding US DMF Number 37957.
Remarkably, this DMF maintains an Active status since its submission on January 18, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 24, 2025, and payment made on July 10, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
