EU active substance registration

Helsinn Birex Pharmaceuticals Ltd

EU active substance registration ASR11368/00001 (AUR24/011 - Annual Update 2024) · Ireland

Key facts

Registration number ASR11368/00001 (AUR24/011 - Annual Update 2024)
EudraGMDP reference 48997
Registration holder Helsinn Birex Pharmaceuticals Limited
Registered site Helsinn Birex Pharmaceuticals Ltd
Site address Damastown, Mulhuddart, Dublin 15, D15 X925
Country Ireland
Competent authority IE_HPRA
National site reference 35
OMS location ID LOC-100000789
OMS organisation ID ORG-100000024
EudraGMDP record eudragmdp.ema.europa.eu

At a glance

  • None Third-country API manufacturing sites
  • 1–9 EudraGMDP certificates and reports for this site

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EU active substance (API) registrations

Companies in the EEA that manufacture, import or distribute active substances for human medicines must register with their national competent authority. EudraGMDP publishes each registration and the third-country sites that supply the substances.

Source: European Medicines Agency (EMA), EudraGMDP database

Browse all EU active substance (API) registrations