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GDUFA

DMF Review : Complete

Rev. Date : 2025-12-04

Pay. Date : 2025-09-29

DMF Number : 34918

Submission : 2020-08-31

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 34918 of Pharmaresources (kaiyuan) Co Ltd

Looking for Drug Master Files (DMF) for 34918 of Pharmaresources (kaiyuan) Co Ltd 1

20

Pharmaresources (kaiyuan) Co Ltd, based in China, is a pharmaceutical company.

One of their notable products is TICAGRELOR, with a corresponding US DMF Number 34918.

Remarkably, this DMF maintains an Active status since its submission on August 31, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2025, and payment made on September 29, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II