01 1Qilu Tianhe Pharmaceutical Co., Ltd.
01 1TOFACITINIB CITRATE (NON-STERILE API)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-06-22
DMF Number : 30578
Submission : 2016-06-13
Status : Active
Type : II
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Shandong Anxin Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is TOFACITINIB CITRATE (NON-STERILE API), with a corresponding US DMF Number 30578.
Remarkably, this DMF maintains an Active status since its submission on June 13, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 21, 2016, and payment made on June 22, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
