01 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1TIOTROPIUM BROMIDE MONOHYDRATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-10-24
Pay. Date : 2025-08-26
DMF Number : 40993
Submission : 2025-07-22
Status : Active
Type : II
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Zhejiang Xianju Pharmaceutical 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 TIOTROPIUM BROMIDE MONOHYDRATE, with a corresponding US DMF Number 40993.
Remarkably, this DMF maintains an Active status since its submission on July 22, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2025, and payment made on August 26, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
