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01 1ITF CHEMICAL LTDA

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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 : 2013-07-08

Pay. Date : 2013-01-18

DMF Number : 26708

Submission : 2012-12-11

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 26708 of Itf Chemical Ltda

Looking for Drug Master Files (DMF) for 26708 of Itf Chemical Ltda 1

20

Itf Chemical Ltda, based in Brazil, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DECITABINE, with a corresponding US DMF Number 26708.

Remarkably, this DMF maintains an Active status since its submission on December 11, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 08, 2013, and payment made on January 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II