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01 1Ercros

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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 : 2013-10-24

Pay. Date : 2013-05-23

DMF Number : 13466

Submission : 1998-09-01

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 13466 of Ercros Sa

Looking for Drug Master Files (DMF) for 13466 of Ercros Sa 1

20

Ercros Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is ERYTHROMYCIN BASE, with a corresponding US DMF Number 13466.

Remarkably, this DMF maintains an Active status since its submission on September 01, 1998, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2013, and payment made on May 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II