01 1Hubei Gedian Humanwell Pharmaceutical
01 1VALGANCICLOVIR HYDROCHLORIDE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-26
Pay. Date : 2025-08-21
DMF Number : 42083
Submission : 2025-06-25
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 VALGANCICLOVIR HYDROCHLORIDE, with a corresponding US DMF Number 42083.
Remarkably, this DMF maintains an Active status since its submission on June 25, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 26, 2025, and payment made on August 21, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
