Merck Serono GmbH

Merck Serono GmbH Overview

Merck Serono GmbH is a pharmaceutical company based in Darmstadt, Hessen. The company operates in the German pharmaceutical market and is regulated by the BfArM (Federal Institute for Drugs and Medical Devices).

Activities & Products

Pharmaceutical companies such as Merck Serono GmbH develop, produce or distribute medicines for the German and international market. All authorised products are subject to approval and are regulated by BfArM or the European Medicines Agency (EMA).

Location & Contact

Merck Serono GmbH can be reached at the following address: Alsfelder Str. 17, 64289 Darmstadt – Phone: 0615162850. For current information and enquiries, please contact the company directly.

More information: Pharmaunternehmen in Hessen or all Pharmaunternehmen in Germany on Sanoliste.

Pharmazeutische Regulierung in Deutschland

Pharmaceutical companies such as Merck Serono GmbH are subject to one of the world's most stringent regulatory frameworks in Germany. The German Medicinal Products Act (AMG) governs the authorisation, manufacturing, distribution and monitoring of medicinal products. Market authorisation for new active substances falls under the responsibility of either the Federal Institute for Drugs and Medical Devices (BfArM) or the European Medicines Agency (EMA), depending on whether a national or centralised authorisation is sought.

Arzneimittelversorgung & Marktumfeld

With a revenue volume exceeding 50 billion euros, the German pharmaceutical market is one of the largest in Europe. Merck Serono GmbH, based in Darmstadt, is part of this market. The supply chain from manufacturer through wholesaler to pharmacy is governed by Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Since the entry into force of the Act for Greater Safety in the Medicinal Products Supply (GSAV), stricter requirements for the traceability of medicinal products also apply.

Pharmastandort Hessen

Hessen is a significant pharmaceutical location in Germany. Companies such as Merck Serono GmbH benefit from proximity to research institutions, university hospitals and well-developed infrastructure. The industry employs over 140,000 people in Germany and invests billions annually in research and development.