01 1Hubei Gedian Humanwell Pharmaceutical
01 1ESLICARBAZEPINE ACETATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-10-22
Pay. Date : 2025-09-25
DMF Number : 42435
Submission : 2025-09-19
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 ESLICARBAZEPINE ACETATE, with a corresponding US DMF Number 42435.
Remarkably, this DMF maintains an Active status since its submission on September 19, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 22, 2025, and payment made on September 25, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
