01 1Qilu Tianhe Pharmaceutical Co., Ltd.
01 1CAPECITABINE (NON-STERILE API)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-06
Pay. Date : 2015-08-19
DMF Number : 27085
Submission : 2013-04-02
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 CAPECITABINE (NON-STERILE API), with a corresponding US DMF Number 27085.
Remarkably, this DMF maintains an Active status since its submission on April 02, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 06, 2016, and payment made on August 19, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
