01 1Medichem S.A
01 1APIXABAN
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-20
Pay. Date : 2016-06-30
DMF Number : 30646
Submission : 2016-06-30
Status : Active
Type : II
20
Medichem Manufacturing (malta) Ltd, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
One of their notable products is APIXABAN, with a corresponding US DMF Number 30646.
Remarkably, this DMF maintains an Active status since its submission on June 30, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 20, 2016, and payment made on June 30, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
