01 1Zhejiang Hisun Pharmaceutical
01 1FLUDARABINE PHOSPHATE USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-15
DMF Number : 16807
Submission : 2003-08-27
Status : Active
Type : II
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Zhejiang Hisun Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is FLUDARABINE PHOSPHATE USP, with a corresponding US DMF Number 16807.
Remarkably, this DMF maintains an Active status since its submission on August 27, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 26, 2012, and payment made on November 15, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
