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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 : 2015-10-05

Pay. Date : 2015-09-25

DMF Number : 15932

Submission : 2002-04-10

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 15932 of Erregierre Spa

Looking for Drug Master Files (DMF) for 15932 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 RALOXIFENE HYDROCHLORIDE, with a corresponding US DMF Number 15932.

Remarkably, this DMF maintains an Active status since its submission on April 10, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 05, 2015, and payment made on September 25, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II