01 1Aurisco Pharmaceutical
01 1ENZALUTAMIDE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-14
Pay. Date : 2020-12-21
DMF Number : 34886
Submission : 2020-06-24
Status : Active
Type : II
20
Aurisco Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is ENZALUTAMIDE, with a corresponding US DMF Number 34886.
Remarkably, this DMF maintains an Active status since its submission on June 24, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 14, 2021, and payment made on December 21, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
