01 1Medichem S.A
01 1PAROXETINE HYDROCHLORIDE HEMIHYDRATE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-08
Pay. Date : 2015-09-14
DMF Number : 18052
Submission : 2005-02-01
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 PAROXETINE HYDROCHLORIDE HEMIHYDRATE, with a corresponding US DMF Number 18052.
Remarkably, this DMF maintains an Active status since its submission on February 01, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 08, 2015, and payment made on September 14, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
