01 1Zhejiang Ausun Pharmaceutical
01 1MACITENTAN
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-04
Pay. Date : 2025-08-13
DMF Number : 41152
Submission : 2025-04-29
Status : Active
Type : II
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Zhejiang Ausun Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Accelerating Development of APIs & Chemical Intermediates through innovation.
One of their notable products is MACITENTAN, with a corresponding US DMF Number 41152.
Remarkably, this DMF maintains an Active status since its submission on April 29, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2025, and payment made on August 13, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
