EU active substance registration

PRIME EUROPEAN THERAPEUTICALS S.P. A. - EUTICALS S.P.A.

EU active substance registration rAPI - 4/2017 · Italy

Key facts

Registration number rAPI - 4/2017
EudraGMDP reference 8670
Registration holder ARCHIMICA S.P. A.
Registered site PRIME EUROPEAN THERAPEUTICALS S.P. A. - EUTICALS S.P.A.
Site address Via Valverde, 20/22, VARESE, 21100
Country Italy
Competent authority IT_AIFA
National site reference 100085
OMS location ID LOC-100023178
OMS organisation ID ORG-100012258
EudraGMDP record eudragmdp.ema.europa.eu

At a glance

  • 1–9 Third-country API manufacturing sites
  • China 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