Humedics GmbH
Pharmaceutical Companies · Berlin
Humedics 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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Humedics GmbH Address & Contact
Company profile
2006
Founded
Humedics GmbH Overview
Humedics GmbH from Berlin is an innovative diagnostics company specializing in breath test diagnostics. With the LiMAx test, Humedics has developed an established method for quantitative liver function measurement, which is used in clinics across Europe. The company was founded in 2013 and has since become a trusted partner in the field of non-invasive diagnostics. Through continuous research and technical innovations, Humedics aims to raise the standards of liver function diagnostics and to better understand the impact of liver diseases on patient health.
Services and Products
The main product is the LiMAx test (Liver Maximum Capacity Test), a non-invasive breath test for the precise determination of individual liver capacity. The system includes a breath testing device, marked substrates, and analysis software. The test allows for a single measurement that delivers results within a few hours, and is particularly critical before hepatic surgeries or for therapy control. The LiMAx test reduces the risk of invasive procedures and provides physicians with valuable information about the functional capacity of the liver.
In addition, Humedics offers comprehensive training and support for medical professionals to ensure correct application of the test. This commitment to high-quality patient care is an essential part of the company's ethos. Humedics is also involved in research on new diagnostic approaches to liver health, enabling the company to be at the forefront of medical innovation.
Regulatory Classification
Humedics has strictly adhered to the applicable regulatory requirements for medical devices in Europe and beyond. The LiMAx test is CE-certified, which means it meets all necessary safety and performance requirements to be used in clinics. Compliance with ISO standards is also part of the company policy, enhancing trust in the quality of the products. In addition to European regulations, the company is actively engaged with the requirements of other markets to ensure broader availability of its products.
Regional Significance
As a Berlin-based company, Humedics benefits not only from the dynamic health tech scene but also from close collaboration with leading research institutions and hospitals in the region. Institutions such as the Charité and Vivantes Clinics provide Humedics access to valuable resources and expertise that are essential for the further development of diagnostic methods. These partnerships enable Humedics to conduct clinical studies, receive valuable feedback from medical professionals, and incorporate the results into product development.
The local presence in Berlin also allows Humedics to be part of a network of start-ups and established companies in the healthcare sector. This fosters the exchange of knowledge and technologies and helps to drive innovations in the field of medical diagnostics.
Company Highlights
A particular strength of Humedics lies in the versatility of the LiMAx test. It is not only suitable for measuring liver function, but also provides insights into the metabolic health of the patient. Moreover, the LiMAx test is used in various clinical applications, including intensive care, transplantation medicine, and gastroenterology, highlighting its significance in modern medicine.
Another unique feature is the company's commitment to advancing breath test technology. Humedics continuously works on improving test accuracy and user-friendliness to increase clinical acceptance and enhance patient care. The company has also set its sights beyond Germany's borders and plans to expand into other international markets to offer its innovative liver diagnostics solutions globally.
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Frequently asked questions about Humedics GmbH
What does Humedics GmbH do?
Humedics GmbH hat sich daron spezialisiert, Ärzten eine schnelle and präzise Möglichkeit zu geben, the Leberfunktion zu messen. Das of ihr developse Gerät kann the Messung in Echtzeit vornehmen and liefert Ergebnisse, the dazu verhelfen, klinische Entscheidungen schneller and genauer vorzunehmen.
How are medicines approved in Germany?
Neue medicines benötigen eine Zulassung durch the BfArM (national) or the EMA (europaweit). Der Prozess umfasst Prüfung of quality, Wirksamkeit and Unbedenklichkeit on Basis klinischer Stuthen.
Was bedeutet GMP?
GMP (Good Manufacturing Practice) is ein System of qualitysstandards for the gleichbleibende manufacturing and Prüfung of medicinesn.
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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.