01 1Qilu Tianhe Pharmaceutical Co., Ltd.
01 1HYDROXYUREA USP (NON-STERILE BULK)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-13
Pay. Date : 2012-12-13
DMF Number : 20615
Submission : 2007-06-15
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 HYDROXYUREA USP (NON-STERILE BULK), with a corresponding US DMF Number 20615.
Remarkably, this DMF maintains an Active status since its submission on June 15, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 13, 2013, and payment made on December 13, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
