01 1Hybio Pharmaceutical
01 1EPTIFIBATIDE ACETATE, NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-01
Pay. Date : 2014-05-07
DMF Number : 26453
Submission : 2012-09-20
Status : Active
Type : II
20
Hybio Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is EPTIFIBATIDE ACETATE, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 26453.
Remarkably, this DMF maintains an Active status since its submission on September 20, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 01, 2014, and payment made on May 07, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
