Shionogi GmbH
Pharmaceutical Companies · Berlin
Shionogi GmbH is a pharmaceutical company based in Berlin, Berlin, Germany. The company operates in the German pharmaceutical market and is regulated by the BfArM (Federal Institute for Drugs and Medical Devices).
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Shionogi GmbH Address & Contact
Company profile
1878
Founded
3.000+
Employees
Shionogi GmbH Overview
Shionogi GmbH is the German subsidiary of the renowned Japanese Shionogi & Co., Ltd., which was founded in 1878 in Osaka. With more than 140 years of experience in the pharmaceutical industry, Shionogi is a pioneer in the development of innovative medicines tailored to the needs of patients. The headquarters of the German company is located in Berlin, from where the company distributes its products and maintains important partnerships with local healthcare providers. Shionogi focuses on combating infectious diseases and makes a significant contribution to public health in Germany.
Field of Activity & Products
Shionogi stands out in Germany with innovative therapeutic approaches in the areas of antiviral and antibacterial therapies. A key product is Xofluza (Baloxavir marboxil), a revolutionary antiviral drug for the treatment of seasonal influenza. This one-time therapy distinguishes itself through its unique mechanism of action as a cap-dependent endonuclease inhibitor, setting it apart from conventional therapies. Additionally, Shionogi offers a range of antibiotics and anti-infectives used to treat severe bacterial infections. Special attention is also given to products specifically targeting resistance in bacterial pathogens, an increasingly pressing problem in modern medicine.
The company continuously invests in research and development of new drugs and therapies and has initiated several clinical studies in recent years. This commitment to innovation also extends to the development of combination therapies and the use of cutting-edge technologies to improve drug efficacy.
History & Regulation
Shionogi & Co., Ltd. is one of the oldest and most respected pharmaceutical companies in Japan. Over the years, it has made a name for itself through groundbreaking developments in drug research. The established standards of quality assurance and drug manufacturing that the company masters are considered benchmarks in Japan and in international markets. All products distributed by Shionogi in Germany must meet the strict approval requirements of the European Medicines Agency (EMA) or the Federal Institute for Drugs and Medical Devices (BfArM) to ensure high efficacy and safety for patients.
In Germany, Shionogi is known not only for the availability of its medications but also plays an active role in the pharmaceutical community. This includes collaboration with health authorities and participation in conferences to monitor current developments in the field of infectious diseases and share knowledge. Shionogi is also involved in various initiatives to promote public health, particularly to raise awareness of antibiotic resistance.
Regional Significance and Features
As a company with a branch in Berlin, Shionogi has special regional significance, as the capital is a crucial center for research and development in healthcare. Proximity to leading scientific institutions and universities allows Shionogi to benefit from current research findings and explore potential collaborations. This strategic location not only fosters the company's innovative capacity but also the dissemination of new therapies in the region and beyond.
Furthermore, Shionogi is actively committed to the continuing education of healthcare professionals to disseminate up-to-date knowledge about antiviral and antibacterial therapies and inform the medical community about new treatment options. These measures underscore the company's commitment to responsible drug use and improving patient care in Germany.
More information: Pharmaceutical companies in Berlin or all pharmaceutical companies in Germany on Sanoliste.
```Frequently asked questions about Shionogi GmbH
What does Shionogi GmbH do?
Shionogi GmbH stellt medicines gegen Infektionskrankheiten her. Besonthee Schwerpunkte are Mittel at HIV, Corvid and the Problembereich the antimikrobiellen Resisenz. In research and development is sie dawith befasst, the medizinische Versorgung on thesem Gebiet weiter zu verbessern. Sie investiert also in the digitale Medizin and develops eine Behandlungs-App.
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About Pharmaceutical Companies
Germany is one of the world's leading pharmaceutical nations, home to more than 1,000 pharmaceutical businesses employing approximately 130,000 people (vfa 2023). Companies operating in this sector develop, manufacture and distribute medicines across the entire value chain, from early-stage research and clinical trials through to market authorisation and commercial distribution. In Germany, every manufacturer of medicinal products must hold a manufacturing authorisation (Herstellungserlaubnis) issued under Section 13 of the AMG (Arzneimittelgesetz, Germany's Medicinal Products Act). Medicines may only be placed on the market after receiving approval from either BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Germany's Federal Institute for Drugs and Medical Devices, broadly comparable to the FDA in the United States or the MHRA in the United Kingdom) or the European Medicines Agency (EMA) via the centralised procedure. All manufacturing sites are subject to regular GMP (Good Manufacturing Practice) inspections carried out by the competent pharmaceutical supervisory authority of the relevant German federal state. The sector covers prescription-only medicines (Rx), non-prescription OTC products, generics, biosimilars and active pharmaceutical ingredients (APIs). This directory lists pharmaceutical manufacturers, marketers and licence holders across all German federal states with full contact details, addresses and phone numbers.
Germany's Pharmaceutical Industry
Germany is consistently ranked among the top five pharmaceutical markets worldwide, generating annual revenues exceeding EUR 50 billion and accounting for the largest share of pharmaceutical production in continental Europe. The industry is represented by two major associations: vfa (Verband Forschender Arzneimittelhersteller), which represents research-based companies, and BAH (Bundesverband der Arzneimittel-Hersteller), which represents the broader manufacturer base including OTC and self-medication products. German pharmaceutical companies cover the full spectrum from global innovator corporations and mid-sized specialty manufacturers to generic producers and biotech firms. The country is a world leader in active pharmaceutical ingredient (API) production, biologics manufacturing and pharmaceutical chemistry. Key therapeutic areas of strength include oncology, cardiovascular medicine, immunology, neuroscience and rare diseases. Germany also serves as a significant export hub, with pharmaceutical products among the country's leading export categories. The sector benefits from a highly skilled workforce, world-class university research institutions and a dense network of research hospitals (Universitätsklinika) that facilitate clinical trial activity.
Regulatory Framework: BfArM, EMA and the AMG
The legal foundation for pharmaceutical activity in Germany is the Arzneimittelgesetz (AMG, German Medicinal Products Act), which regulates the authorisation, manufacture, import, distribution, labelling and pharmacovigilance of medicinal products. For English-speaking readers unfamiliar with the German regulatory landscape: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is the national competent authority responsible for approving medicines marketed only in Germany, supervising narcotics, and maintaining the pharmacovigilance database. BfArM is a higher federal authority (Bundesoberbehörde) subordinate to the Federal Ministry of Health (Bundesministerium für Gesundheit). For medicines approved via the centralised EU procedure, the European Medicines Agency (EMA) grants a single marketing authorisation valid in all 27 EU member states. Germany is also home to the Paul-Ehrlich-Institut (PEI), a second federal authority that specifically handles biological medicines including vaccines, blood products and gene therapy products. Manufacturing sites are inspected by state-level pharmaceutical supervisory authorities (Landesbehörden) to verify GMP compliance, with findings entered into the EudraGMDP database operated by the EMA.
Regional Pharmaceutical Clusters in Germany
Germany's pharmaceutical industry is geographically distributed across several major regional clusters. The Rhine-Main area around Frankfurt and Leverkusen in North Rhine-Westphalia is home to some of Germany's largest pharmaceutical sites, including facilities belonging to global corporations with long histories in German chemistry and pharmaceuticals. Bavaria (particularly Munich, Penzberg and Marburg) is a second major hub, especially strong in biotechnology and biologics production. Baden-Württemberg, including cities such as Mannheim, Heidelberg and Biberach an der Riss, is home to several significant research-based manufacturers. Hamburg and the northern German region have a cluster of specialty and generic manufacturers. Berlin has a growing biotech scene connected to its research universities and the Charité hospital. Hesse is notable for its proximity to Frankfurt's logistics infrastructure and several major API manufacturers. Smaller but significant clusters exist in Saxony (Leipzig, Dresden) and Lower Saxony, benefiting from proximity to university research centres and historically established chemical industry sites.
Drug Classes and Product Segments
German pharmaceutical companies cover all major drug classes. Prescription (Rx) products account for the largest share of revenue; generics manufacturers such as Stada, ratiopharm (Teva) and Hexal produce chemically equivalent alternatives after patent expiry, significantly reducing costs for the healthcare system. Biologics and biosimilars are gaining ground rapidly: monoclonal antibodies, insulin analogues and recombinant growth factors require specialised biotech manufacturing facilities. OTC products (over-the-counter), i.e. medicines available without a prescription, represent a multi-billion-euro market served by companies such as Bayer Consumer Health, Stada and Klosterfrau. Homeopathic preparations, herbal medicines and dietary supplements form further regulated segments. Digitalisation is increasingly shaping the sector: Digital Health Applications (DiGA) have been reimbursable since 2020, and AI-assisted drug development is significantly shortening time-to-market.
What does a pharmaceutical company do?
Pharmaceutical companies develop, produce and distribute medicines. They cover the entire value chain from research and clinical trials through to market launch and distribution. In Germany, they are supervised by BfArM (the Federal Institute for Drugs and Medical Devices, comparable to the FDA or MHRA).
How are pharmaceutical companies regulated in Germany?
Pharmaceutical companies in Germany must hold a manufacturing authorisation under Section 13 of the AMG (German Medicinal Products Act). All authorised medicines require approval from either BfArM or the European Medicines Agency (EMA). Regular GMP (Good Manufacturing Practice) inspections ensure quality standards are maintained.
Where can I find contact details for pharmaceutical companies in Germany?
Industry associations such as vfa (Association of Research-Based Pharmaceutical Companies) and BPI (Federal Association of the German Pharmaceutical Industry) maintain member directories. Many companies also list their key contacts directly on their websites. Sanoliste provides a searchable directory of pharmaceutical companies in Germany sorted by federal state and city.
How many pharmaceutical companies are there in Germany?
Germany is home to more than 1,000 pharmaceutical companies employing approximately 130,000 people, according to vfa (the Association of Research-Based Pharmaceutical Companies) 2023 data. The sector includes multinational corporations, mid-sized specialty firms, generic manufacturers and biotech startups.
What is BfArM and what does it regulate?
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is Germany's Federal Institute for Drugs and Medical Devices. It is a higher federal authority within the portfolio of the Federal Ministry of Health and is responsible for approving medicines for the German market, monitoring drug safety (pharmacovigilance), regulating narcotics and controlled substances, and overseeing medical devices in Germany. It is broadly comparable to the FDA in the United States or the MHRA in the United Kingdom.
What is the difference between BfArM approval and EMA approval?
Medicines in Germany can be approved through two main routes. BfArM grants national marketing authorisations valid in Germany, or decentralised and mutual recognition procedure approvals valid in multiple EU states. The EMA (European Medicines Agency) grants centralised marketing authorisations valid in all 27 EU member states simultaneously, typically used for innovative biologic medicines, oncology drugs and products for rare diseases.
What does GMP mean in the context of German pharmaceutical manufacturing?
GMP stands for Good Manufacturing Practice. In Germany and the EU, GMP compliance is a legal requirement for all pharmaceutical manufacturers under the AMG and the EU GMP Guidelines (EudraLex Volume 4). GMP covers all aspects of production including premises, equipment, personnel qualification, process validation, documentation and quality control. Compliance is verified by regular inspections from the competent state pharmaceutical supervisory authority.