01 1Changzhou Pharmaceutical Factory
01 1NIRAPARIB TOSYLATE MONOHYDRATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-22
Pay. Date : 2024-09-27
DMF Number : 39449
Submission : 2024-02-07
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 NIRAPARIB TOSYLATE MONOHYDRATE, with a corresponding US DMF Number 39449.
Remarkably, this DMF maintains an Active status since its submission on February 07, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 22, 2024, and payment made on September 27, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
