01 1Shandong Xinhua Pharmaceutical
01 1IBUPROFEN
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-16
Pay. Date : 2014-06-04
DMF Number : 15511
Submission : 2001-07-03
Status : Active
Type : II
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Shandong Xinhua 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 IBUPROFEN, with a corresponding US DMF Number 15511.
Remarkably, this DMF maintains an Active status since its submission on July 03, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 16, 2014, and payment made on June 04, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
