Please Wait
Applying Filters...
Menu
Xls
Filters Filter
Cross PopUp
FILTER :

filter clear-filterReset all filters

01 1Ercros

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

PharmaCompass

01

BePharma
Not Confirmed

01

BePharma
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2017-08-01

Pay. Date : 2017-07-13

DMF Number : 13654

Submission : 1998-09-01

Status : Active

Type : II

blank

Looking for Drug Master Files (DMF) for 13654 of Ercros Sa

Looking for Drug Master Files (DMF) for 13654 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 ETHYLSUCCINATE, with a corresponding US DMF Number 13654.

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 August 01, 2017, and payment made on July 13, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II