01 1Qilu Tianhe Pharmaceutical Co., Ltd.
01 1AMIKACIN SULFATE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-25
Pay. Date : 2013-11-18
DMF Number : 20874
Submission : 2007-09-18
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 AMIKACIN SULFATE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT, with a corresponding US DMF Number 20874.
Remarkably, this DMF maintains an Active status since its submission on September 18, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 25, 2013, and payment made on November 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
