01 1Jiangsu Hengrui Medicine
01 1GADOTERATE MEGLUMINE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-29
Pay. Date : 2020-03-13
DMF Number : 34673
Submission : 2020-03-31
Status : Active
Type : II
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Jiangsu Hengrui Pharmaceuticals 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 GADOTERATE MEGLUMINE, with a corresponding US DMF Number 34673.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 29, 2020, and payment made on March 13, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
