EU active substance registration

Rottapharm Ltd

EU active substance registration ASR11339/00001 (Annual Update 2021: AUR21/044-047) · Ireland

Key facts

Registration number ASR11339/00001 (Annual Update 2021: AUR21/044-047)
EudraGMDP reference 37186
Registration holder Rottapharm Ltd
Registered site Rottapharm Ltd
Site address Damastown Industrial Park, Mulhuddart, Dublin 15, XD71
Country Ireland
Competent authority IE_HPRA
National site reference 136
OMS location ID LOC-100000738
OMS organisation ID ORG-100000521
EudraGMDP record eudragmdp.ema.europa.eu

At a glance

  • 1–9 Third-country API manufacturing sites
  • Thailand Supplier countries outside the EEA
  • 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