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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 : 2013-01-30

Pay. Date : 2013-01-10

DMF Number : 16215

Submission : 2002-10-22

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 16215 of Erregierre Spa

Looking for Drug Master Files (DMF) for 16215 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 NISOLDIPINE, with a corresponding US DMF Number 16215.

Remarkably, this DMF maintains an Active status since its submission on October 22, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 30, 2013, and payment made on January 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II