01 1Medichem S.A
01 1EDARAVONE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-04
Pay. Date : 2020-10-15
DMF Number : 35211
Submission : 2020-10-26
Status : Active
Type : II
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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 EDARAVONE, with a corresponding US DMF Number 35211.
Remarkably, this DMF maintains an Active status since its submission on October 26, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2020, and payment made on October 15, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
