01 1Lunan Pharmaceutical
01 1DALFAMPRIDINE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-11-13
Pay. Date : 2025-09-23
DMF Number : 42075
Submission : 2025-07-25
Status : Active
Type : II
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Shandong New Time Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is DALFAMPRIDINE, with a corresponding US DMF Number 42075.
Remarkably, this DMF maintains an Active status since its submission on July 25, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 13, 2025, and payment made on September 23, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
