01 1Erregierre SpA
01 1MESALAMINE USP-EP
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-28
Pay. Date : 2015-09-18
DMF Number : 13883
Submission : 1998-12-03
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-EP, with a corresponding US DMF Number 13883.
Remarkably, this DMF maintains an Active status since its submission on December 03, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 28, 2015, and payment made on September 18, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
