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01 1ITF CHEMICAL LTDA

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PharmaCompass

01

ChemTides
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ChemTides
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GDUFA

DMF Review : Complete

Rev. Date : 2013-09-20

Pay. Date : 2012-12-21

DMF Number : 26534

Submission : 2012-10-10

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 26534 of Itf Chemical Ltda

Looking for Drug Master Files (DMF) for 26534 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 TEMOZOLOMIDE, USP, with a corresponding US DMF Number 26534.

Remarkably, this DMF maintains an Active status since its submission on October 10, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 20, 2013, and payment made on December 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II