01 1Zhejiang Huahai Pharmaceutical
01 1DABIGATRAN ETEXILATE MESYLATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-02
Pay. Date : 2014-07-22
DMF Number : 28419
Submission : 2014-07-10
Status : Active
Type : II
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Zhejiang Huahai 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 DABIGATRAN ETEXILATE MESYLATE, with a corresponding US DMF Number 28419.
Remarkably, this DMF maintains an Active status since its submission on July 10, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 02, 2014, and payment made on July 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
