01 1HEC Pharm
01 1APIXABAN NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-22
Pay. Date : 2016-09-12
DMF Number : 30874
Submission : 2016-08-31
Status : Active
Type : II
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Ruyuan Hec Pharm 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 APIXABAN NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 30874.
Remarkably, this DMF maintains an Active status since its submission on August 31, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 22, 2016, and payment made on September 12, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
