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01 1Laboratorio Chimico Internazionale Spa

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PharmaCompass

01

BePharma
Not Confirmed

01

BePharma
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-31

Pay. Date : 2013-05-16

DMF Number : 25973

Submission : 2012-04-16

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 25973 of Olon Spa

Looking for Drug Master Files (DMF) for 25973 of Olon Spa 1

20

Olon Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is ETHACRYNIC ACID, with a corresponding US DMF Number 25973.

Remarkably, this DMF maintains an Active status since its submission on April 16, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 31, 2013, and payment made on May 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II