01 1Changzhou Pharmaceutical Factory
01 1EZETIMIBE (ROUTE CODE: ZT)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-03
Pay. Date : 2023-05-18
DMF Number : 35963
Submission : 2021-05-27
Status : Active
Type : II
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Changzhou Pharmaceutical Factory, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is EZETIMIBE (ROUTE CODE: ZT), with a corresponding US DMF Number 35963.
Remarkably, this DMF maintains an Active status since its submission on May 27, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 03, 2023, and payment made on May 18, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
