EU active substance registration

Niche Generics Ltd

EU active substance registration ASR11347/00001 (AUR20/062) - Annual Update 2020 · Ireland

Key facts

Registration number ASR11347/00001 (AUR20/062) - Annual Update 2020
EudraGMDP reference 23947
Registration holder Niche Generics Ltd
Registered site Niche Generics Ltd
Site address Unit 5 151 Baldoyle Industrial Estate, Baldoyle, Dublin 13, D13 YC95
Country Ireland
Competent authority IE_HPRA
National site reference ASR11347/00001
OMS location ID LOC-100026286
OMS organisation ID ORG-100017509
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