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 : 2016-03-08

Pay. Date : 2015-08-07

DMF Number : 29462

Submission : 2015-06-26

Status : Active

Type : II

blank

Looking for Drug Master Files (DMF) for 29462 of Quimica Sintetica Sa

Looking for Drug Master Files (DMF) for 29462 of Quimica Sintetica Sa 1

20

Quimica Sintetica Sa, based in Spain, is a pharmaceutical company.

One of their notable products is LANSOPRAZOLE (PROCESS II), with a corresponding US DMF Number 29462.

Remarkably, this DMF maintains an Active status since its submission on June 26, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 08, 2016, and payment made on August 07, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II