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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 : 2013-11-01

Pay. Date : 2013-06-19

DMF Number : 18147

Submission : 2005-03-04

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 18147 of Olon Spa

Looking for Drug Master Files (DMF) for 18147 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 NAFTIFINE HYDROCHLORIDE, with a corresponding US DMF Number 18147.

Remarkably, this DMF maintains an Active status since its submission on March 04, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 01, 2013, and payment made on June 19, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II