01 1Jiangsu Hengrui Medicine
01 1DEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2013-04-29
DMF Number : 26377
Submission : 2012-09-04
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 DEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE, with a corresponding US DMF Number 26377.
Remarkably, this DMF maintains an Active status since its submission on September 04, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2014, and payment made on April 29, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
