01 1Erregierre SpA
01 1MESALAMINE USP - PH.EUR. (HIGH DENSITY)
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-27
Pay. Date : 2014-03-26
DMF Number : 24889
Submission : 2011-04-26
Status : Active
Type : II
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Erregierre Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is MESALAMINE USP - PH.EUR. (HIGH DENSITY), with a corresponding US DMF Number 24889.
Remarkably, this DMF maintains an Active status since its submission on April 26, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 27, 2015, and payment made on March 26, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
