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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 : 2013-11-22

Pay. Date : 2013-03-16

DMF Number : 26961

Submission : 2013-03-18

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 26961 of Olon Spa

Looking for Drug Master Files (DMF) for 26961 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 PIROXICAM, with a corresponding US DMF Number 26961.

Remarkably, this DMF maintains an Active status since its submission on March 18, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 22, 2013, and payment made on March 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II