01 1Zhejiang Ausun Pharmaceutical
01 1ENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2013-10-30
DMF Number : 25200
Submission : 2011-08-05
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 ENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 25200.
Remarkably, this DMF maintains an Active status since its submission on August 05, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 07, 2014, and payment made on October 30, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
