01 1Erregierre SpA
01 1PROPAFENONE HYDROCHLORIDE USP-EP
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-04
Pay. Date : 2017-01-20
DMF Number : 13010
Submission : 1998-06-01
Status : Active
Type : II
20
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 PROPAFENONE HYDROCHLORIDE USP-EP, with a corresponding US DMF Number 13010.
Remarkably, this DMF maintains an Active status since its submission on June 01, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 04, 2019, and payment made on January 20, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
