01 1Zhejiang Ausun Pharmaceutical
01 1OLAPARIB
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-10-28
Pay. Date : 2025-09-23
DMF Number : 41845
Submission : 2025-04-30
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 OLAPARIB, with a corresponding US DMF Number 41845.
Remarkably, this DMF maintains an Active status since its submission on April 30, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 28, 2025, and payment made on September 23, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
