01 1Medichem S.A
01 1MEXILETINE HYDROCHLORIDE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-21
Pay. Date : 2019-05-23
DMF Number : 9257
Submission : 1991-07-26
Status : Active
Type : II
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Medichem Sa, 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 MEXILETINE HYDROCHLORIDE, with a corresponding US DMF Number 9257.
Remarkably, this DMF maintains an Active status since its submission on July 26, 1991, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 21, 2019, and payment made on May 23, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
