01 1Erregierre SpA
01 1BUPROPION HYDROCHLORIDE USP
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-09-03
DMF Number : 11054
Submission : 1994-08-30
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 BUPROPION HYDROCHLORIDE USP, with a corresponding US DMF Number 11054.
Remarkably, this DMF maintains an Active status since its submission on August 30, 1994, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 10, 2013, and payment made on September 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
