Kedrion Biopharma GmbH
Pharmaceutical Companies · München
Kedrion Biopharma GmbH is a pharmaceutical company based in München, Bavaria, 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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Kedrion Biopharma GmbH Address & Contact
Company profile
5.000+ (global)
Employees
Kedrion Biopharma GmbH Overview
Kedrion Biopharma GmbH is the German subsidiary of the Italian plasma derivatives manufacturer Kedrion Biopharma S.p.A., one of the leading European specialists in plasma-based therapies. The company is based in Munich and plays a significant role in the field of biopharmaceuticals, particularly in supplying patients with special therapeutic needs. In 2023, Kedrion was able to further expand its market share in Germany and is now one of the most important providers in the plasma derivatives segment.
Plasma Derivatives and Hemostasis Therapy
Kedrion specializes in the manufacture and marketing of medicines derived from human blood plasma. The portfolio includes immunoglobulins (intravenous and subcutaneous), clotting factors for hemophiliacs, albumin solutions, as well as antithrombin and other plasma coagulation inhibitors. These life-saving blood products are needed by patients with immune deficiencies, bleeding disorders, and coagulation disorders. In addition, Kedrion is engaged in researching new therapeutic approaches. In recent years, the company has successfully initiated clinical studies on the use of plasma substances in the treatment of rare diseases, highlighting the company's innovative strength and scientific ambition.
Particularly noteworthy is the regulatory classification of Kedrion Biopharma. The products are subject to strict quality assurance requirements established in European and international guidelines. These standards ensure that the manufactured products are not only safe but also effective. This is particularly important in biopharmaceuticals, where every batch of plasma derivatives is carefully tested for purity and efficacy.
Location Munich
From Munich, Kedrion supplies hemophilia centers, immunology specialist practices, and hospital pharmacies across Germany. Here, the strategic location plays a crucial role: Munich provides Kedrion access to the German hematology network and the most important oncology-hematology university hospitals. This close collaboration with medical professionals enables the company to understand patients' needs accurately and respond promptly to new challenges in healthcare.
Kedrion also relies on regional partnerships and initiatives to improve therapies and explore new treatment methods. The company is committed to local projects and support offerings that benefit both medical professionals and patient groups. This accentuates the regional significance of Kedrion as an important player in healthcare in and around Munich.
Special Features and Innovations
Kedrion Biopharma places great emphasis on research and development. In collaboration with academic institutions and other biotechnology companies, Kedrion is constantly seeking innovative approaches to improve existing therapies. One example is the development of innovative formulations that facilitate patients' access to therapies, such as the introduction of self-injection systems for patients with hemophilia. These systems enable patients to carry out their therapy themselves at home, significantly enhancing their quality of life.
Furthermore, Kedrion is engaged in raising awareness and educating about rare blood coagulation disorders. Regular information events and workshops for doctors as well as patients ensure that the latest findings in therapy are disseminated quickly. Kedrion also actively participates in patient organizations to promote exchange and give a voice to those affected.
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Frequently asked questions about Kedrion Biopharma GmbH
What does Kedrion Biopharma GmbH do?
Kedrion Biopharma GmbH hat als ein Aufgabengebiet the Gewinnung of Humanplasma and antheen Blutkomponenten zu medizinischen Zwecken. Dazu underhält sie verschiedene Blutspendethenste. Das gewonnene Plasma is zerlegt and in verschiedenen Medikamenten weiterverarattet. Die plasmabasierten therapeutischen Mittel are zur Heilung of Immunschwäche or Hämophilie eingesetzt.
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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.