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01 1SOLUTEX GC SL

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PharmaCompass

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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2016-07-28

Pay. Date : 2016-03-15

DMF Number : 28246

Submission : 2014-05-19

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 28246 of Chemo Iberica Sa

Looking for Drug Master Files (DMF) for 28246 of Chemo Iberica Sa 1

20

Chemo Iberica Sa, based in Spain, is a pharmaceutical company.

One of their notable products is OMEGA-3-ACID ETHYL ESTERS, with a corresponding US DMF Number 28246.

Remarkably, this DMF maintains an Active status since its submission on May 19, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on March 15, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II