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01 1CHEMO IBERICA SA

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PharmaCompass

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GDUFA

DMF Review : Complete

Rev. Date : 2014-01-17

Pay. Date : 2013-09-27

DMF Number : 24487

Submission : 2010-12-23

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 24487 of Quimica Sintetica Sa

Looking for Drug Master Files (DMF) for 24487 of Quimica Sintetica Sa 1

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

One of their notable products is LANSOPRAZOLE USP, with a corresponding US DMF Number 24487.

Remarkably, this DMF maintains an Active status since its submission on December 23, 2010, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 17, 2014, and payment made on September 27, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II