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01 1Erregierre SpA

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PharmaCompass

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BePharma
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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2015-05-15

Pay. Date : 2014-04-14

DMF Number : 18706

Submission : 2005-08-15

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 18706 of Erregierre Spa

Looking for Drug Master Files (DMF) for 18706 of Erregierre Spa 1

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 ARIPIPRAZOLE USP-EP, with a corresponding US DMF Number 18706.

Remarkably, this DMF maintains an Active status since its submission on August 15, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 15, 2015, and payment made on April 14, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II