Flen Health GmbH
Pharmaceutical Companies · Düsseldorf
Flen Health GmbH is a pharmaceutical company based in Düsseldorf, North Rhine-Westphalia, 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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Flen Health GmbH Address & Contact
Flen Health GmbH at a Glance
Flen Health GmbH is the German branch of the Belgian specialty pharmaceutical company Flen Health, which focuses on dermatological therapies, particularly the treatment of chronic wounds and skin diseases. Over the years, the company has established itself as a trusted partner in healthcare and offers innovative solutions tailored to the needs of patients and professionals.
Dermatology and Wound Treatment
Flen Health is known for its product Flaminal, an enzymatic wound gel line based on algae, which is particularly used for chronic wounds such as venous leg ulcers, pressure sores, and burns. Flaminal is characterized by its special formulation that provides an antimicrobial and moisture-regulating effect without relying on conventional antibiotics or silver. This is especially important in times of increasing antibiotic resistance, as it offers an effective and safe treatment alternative. The enzymatic properties of Flaminal also promote the natural healing process of the skin and reduce the risk of infections.
Additionally, Flen Health distributes products for the treatment of eczema and other chronic skin diseases, which are also based on scientific studies. The company conducts a series of clinical trials to continuously verify and improve the effectiveness and safety of its products.
Regulatory Classification and Certifications
The products of Flen Health are subject to strict regulatory requirements that apply in the European Union. As a pharmaceutical company, Flen Health meets the requirements of the European Medicines Agency (EMA) as well as the guidelines for medical devices. All products are CE-certified and are regularly assessed for their effectiveness and safety. The close collaboration with medical professional organizations and participation in research communities enables Flen Health to comply with current standards and best practices in dermatology.
Düsseldorf Location
Düsseldorf as a location enables Flen Health Germany to have a central position in the German wound care market. The location in the North Rhine-Westphalian capital offers versatile advantages: it serves as a hub for communication with doctors, clinics, and nursing services. From here, wound management experts, dermatologists, and inpatient care facilities are supported. Access to a comprehensive network of healthcare providers and proximity to renowned research institutions foster innovative developments and enable a rapid exchange of knowledge and technologies.
Moreover, Flen Health GmbH is committed to the North Rhine-Westphalia region through training programs and workshops for medical professionals. This ensures that the latest insights into wound treatment and dermatological therapy forms are implemented in practical applications on site. The company is also active in regional health initiatives and supports local projects to improve patient care.
Special Features of Flen Health GmbH
Another notable feature of Flen Health is its strong focus on research and development. The company conducts extensive research projects that address new treatment approaches and the advancement of existing products. The close collaboration with universities and research institutes enables the development of innovative solutions that are in line with the latest scientific findings.
In addition to research, Flen Health is committed to actively improving patient care. In close cooperation with care facilities and doctors, the company develops practical training offerings. These partnerships promote the application of evidence-based treatment methods and contribute to quality assurance in wound care.
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```Frequently asked questions about Flen Health GmbH
What does Flen Health GmbH do?
Flen Health GmbH stellt Mittel zur Hautpflege and -heilung and zur Wandversorgung her. Im Portfolio are Mittel zur Behandlung akuter and chronischer Wanden, zur Wandreinigung and Mittel zur Behandlung the Haut at strahlungsbedingter Dermatitis.
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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.