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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 : 2014-10-10

Pay. Date : 2014-03-20

DMF Number : 17367

Submission : 2004-05-05

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 17367 of Quimica Sintetica Sa

Looking for Drug Master Files (DMF) for 17367 of Quimica Sintetica Sa 1

20

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

One of their notable products is ISRADIPINE, with a corresponding US DMF Number 17367.

Remarkably, this DMF maintains an Active status since its submission on May 05, 2004, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 10, 2014, and payment made on March 20, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II