01 1Urquima S.A. Grupo Uriach
01 1IVABRADINE HYDROCHLORIDE (FORM IV)
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-01
Pay. Date : 2018-10-19
DMF Number : 33213
Submission : 2018-10-15
Status : Active
Type : II
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Urquima Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is IVABRADINE HYDROCHLORIDE (FORM IV), with a corresponding US DMF Number 33213.
Remarkably, this DMF maintains an Active status since its submission on October 15, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 01, 2019, and payment made on October 19, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
