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01 1CHEMO IBERICA SA

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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 : 2015-06-01

Pay. Date : 2015-03-16

DMF Number : 28920

Submission : 2014-12-15

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 28920 of Quimica Sintetica Sa

Looking for Drug Master Files (DMF) for 28920 of Quimica Sintetica Sa 1

20

Quimica Sintetica Sa, based in Spain, is a pharmaceutical company.

One of their notable products is LEVOFLOXACIN, with a corresponding US DMF Number 28920.

Remarkably, this DMF maintains an Active status since its submission on December 15, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 01, 2015, and payment made on March 16, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II