01 1Aurisco Pharmaceutical
01 1INCLISIRAN SODIUM
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-10-23
Pay. Date : 2025-09-25
DMF Number : 42095
Submission : 2025-09-24
Status : Active
Type : II
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Yangzhou Aurisco Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is INCLISIRAN SODIUM, with a corresponding US DMF Number 42095.
Remarkably, this DMF maintains an Active status since its submission on September 24, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 23, 2025, and payment made on September 25, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
