Roxall Medizin GmbH
Pharmaceutical Companies · Hamburg
Roxall Medizin GmbH is a pharmaceutical company based in Hamburg, Hamburg, 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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Roxall Medizin GmbH Address & Contact
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Roxall Medizin GmbH at a Glance
Roxall Medizin GmbH, the German subsidiary of the internationally operating company Roxall, is based in Hamburg. Specializing in the development and marketing of pharmaceuticals in the field of allergen immunotherapy, Roxall significantly contributes to improving the quality of life for people with allergies. Corporate culture and a spirit of innovation shape daily actions, always keeping the goal of providing effective solutions for patients suffering from respiratory allergies and other allergic conditions in mind.
Area of Activity & Products
The product portfolio of Roxall includes a variety of therapeutic approaches to meet the diverse needs of allergy sufferers. The company offers both subcutaneous immunotherapies (SCIT) and sublingual immunotherapies (SLIT). These therapies are specifically designed for patients with allergic rhinitis, allergic asthma, and insect venom allergies. The allergen extracts are made from natural raw materials such as grass and tree pollen, house dust mites, and animal epithelium. The selection of raw materials is based on strict quality criteria to guarantee the effectiveness and safety of the therapies.
- Subcutaneous Immunotherapies (SCIT): This method involves injections of allergen extracts under the skin, which is intended to bring about a slow and controlled desensitization of the immune system.
- Sublingual Immunotherapies (SLIT): In this case, the allergen extracts are placed under the tongue, allowing for an uncomplicated application particularly suitable for patients who fear injections.
- Ready-to-Use Solutions: To enhance user-friendliness, Roxall also offers ready-to-use solutions that further simplify treatment.
Regulation
The allergen immunotherapeutics of Roxall Medizin GmbH are subject to special approval requirements in Germany according to § 36 AMG. The company ensures that all regulatory requirements of the Federal Institute for Drugs and Medical Devices (BfArM) for allergen drugs are always met. This includes strict compliance with the quality standards of the European Pharmacopoeia, which is regularly verified by independent testing institutions.
Roxall is deeply engaged in the safety monitoring of its products. All clinical trials are conducted according to applicable guidelines to document the safety and efficacy of the therapies. This includes not only preclinical research but also extensive clinical studies that form the basis for the approval of the drugs.
Regional Significance
Roxall Medizin GmbH plays a significant role in the Hamburg region, both economically and in terms of healthcare provision. As one of the leading providers in the field of allergy therapies, the company influences the local pharmaceutical landscape and cooperates closely with dermatologists, allergists, and ENT specialists. There are numerous projects in the region focused on educating and raising awareness among patients with allergies, with Roxall playing a key role.
Special Features
A distinctive feature of Roxall is its commitment to research and development. The company continuously invests in the improvement of existing products and the development of innovative therapeutic approaches to meet the constantly growing demands in healthcare. Furthermore, Roxall places great importance on close collaboration with specialists and scientific institutions to continually optimize the applications of its products and integrate new findings in allergy research.
In summary, it can be said that Roxall Medizin GmbH is not only a key player in the field of allergological therapies but also makes a significant contribution to improving the quality of life for patients with allergies. With innovative products and a strong focus on quality and safety, Roxall sets standards in allergen immunotherapy.
More information: Pharmaceutical Companies in Hamburg or all pharmaceutical companies in Germany on Sanoliste.
Frequently asked questions about Roxall Medizin GmbH
What does Roxall Medizin GmbH do?
Roxall Medizin GmbH is a pharmaceutical company based in Hamburg that develops, manufactures or distributes pharmaceutical products. The company is active in the German healthcare market.
Where is Roxall Medizin GmbH located?
Roxall Medizin GmbH is headquartered in Hamburg, Germany. More information can be found on the company's website.
What products does Roxall Medizin GmbH distribute?
Roxall Medizin GmbH is active in the pharmaceutical sector. Detailed information on the products offered and therapeutic areas can be found on the company's website or via the contact details provided.
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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.