01 1Medichem S.A
01 1CINACALCET HYDROCHLORIDE (MED-200140/M )
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-25
Pay. Date : 2014-03-14
DMF Number : 21405
Submission : 2008-03-06
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 CINACALCET HYDROCHLORIDE (MED-200140/M ), with a corresponding US DMF Number 21405.
Remarkably, this DMF maintains an Active status since its submission on March 06, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2014, and payment made on March 14, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
