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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 : 2014-08-27

Pay. Date : 2014-07-01

DMF Number : 27953

Submission : 2014-03-18

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 27953 of Itf Chemical Ltda

Looking for Drug Master Files (DMF) for 27953 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 AZACYTIDINE, with a corresponding US DMF Number 27953.

Remarkably, this DMF maintains an Active status since its submission on March 18, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 27, 2014, and payment made on July 01, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II