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

filter clear-filterReset all filters

01 1CHEMO IBERICA SA

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 : 2018-01-05

Pay. Date : 2017-11-27

DMF Number : 32133

Submission : 2017-10-13

Status : Active

Type : II

blank

Looking for Drug Master Files (DMF) for 32133 of Chemo Sms Enterprise Sl

Looking for Drug Master Files (DMF) for 32133 of Chemo Sms Enterprise Sl 1

20

Chemo Sms Enterprise Sl, based in Spain, is a pharmaceutical company.

One of their notable products is RANOLAZINE, with a corresponding US DMF Number 32133.

Remarkably, this DMF maintains an Active status since its submission on October 13, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2018, and payment made on November 27, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II