EU active substance registration

Samsung Bioepis NL B.V.

EU active substance registration 16355 API · Netherlands

Key facts

Registration number 16355 API
EudraGMDP reference 32085
Registration holder Samsung Bioepis NL B.V.
Registered site Samsung Bioepis NL B.V.
Site address Olof Palmestraat 10, Delft, 2616 LR
Country Netherlands
Competent authority NL_FARMATEC
National site reference FUSY/68845
OMS location ID LOC-100018323
OMS organisation ID ORG-100012628
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