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

filter clear-filterReset all filters

01 1EUROAPI

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-23

Pay. Date : 2013-11-15

DMF Number : 21144

Submission : 2007-06-20

Status : Active

Type : II

EUROAPI Compnay Banner

Looking for Drug Master Files (DMF) for 21144 of Francopia A Euroapi Co

Looking for Drug Master Files (DMF) for 21144 of Francopia A Euroapi Co 1

20

Francopia A Euroapi Co, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

One of their notable products is NALBUPHINE HYDROCHLORIDE, with a corresponding US DMF Number 21144.

Remarkably, this DMF maintains an Active status since its submission on June 20, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 23, 2014, and payment made on November 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II