01 1Medichem S.A
01 1REVEFENACIN
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-10
Pay. Date : 2022-04-11
DMF Number : 36861
Submission : 2022-04-19
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 REVEFENACIN, with a corresponding US DMF Number 36861.
Remarkably, this DMF maintains an Active status since its submission on April 19, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 10, 2022, and payment made on April 11, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
