01 1Changzhou Pharmaceutical Factory
01 1BALOXAVIR MARBOXIL
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-06
Pay. Date : 2022-02-25
DMF Number : 36657
Submission : 2021-12-31
Status : Active
Type : II
20
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 BALOXAVIR MARBOXIL, with a corresponding US DMF Number 36657.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 06, 2022, and payment made on February 25, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
