01 1Synbias Pharma Limited Liability Company
01 1EPIRUBICIN HYDROCHLORIDE
01 1Ukraine
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-02
Pay. Date : 2013-06-20
DMF Number : 16258
Submission : 2002-10-31
Status : Active
Type : II
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Synbias Pharma Ag, based in Ukraine, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is EPIRUBICIN HYDROCHLORIDE, with a corresponding US DMF Number 16258.
Remarkably, this DMF maintains an Active status since its submission on October 31, 2002, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 02, 2013, and payment made on June 20, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
