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01 1Laboratorio Chimico Internazionale Spa

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PharmaCompass

01

BePharma
Not Confirmed

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BePharma
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-04

Pay. Date : 2013-09-30

DMF Number : 11267

Submission : 1994-12-23

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 11267 of Olon Spa

Looking for Drug Master Files (DMF) for 11267 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 DICLOFENAC POTASSIUM, with a corresponding US DMF Number 11267.

Remarkably, this DMF maintains an Active status since its submission on December 23, 1994, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 04, 2013, and payment made on September 30, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II