01 1Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
01 1AMANTADINE HYDROCHLORIDE USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-04-28
DMF Number : 25151
Submission : 2011-07-21
Status : Active
Type : II
20
Zhejiang Apeloa Kangyu 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 AMANTADINE HYDROCHLORIDE USP, with a corresponding US DMF Number 25151.
Remarkably, this DMF maintains an Active status since its submission on July 21, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2015, and payment made on April 28, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
