01 1Qilu Pharmaceutical
01 1PALONOSETRON HYDROCHLORIDE USP (NON STERILE API)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-27
Pay. Date : 2012-12-26
DMF Number : 24661
Submission : 2011-02-19
Status : Active
Type : II
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Qilu Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is PALONOSETRON HYDROCHLORIDE USP (NON STERILE API), with a corresponding US DMF Number 24661.
Remarkably, this DMF maintains an Active status since its submission on February 19, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 27, 2013, and payment made on December 26, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
