Leyh Pharma GmbH
Pharmaceutical Companies · Schmalkalden-Meiningen
Leyh Pharma GmbH is a pharmaceutical company based in Schmalkalden-Meiningen, Thuringia, 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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Leyh Pharma GmbH Address & Contact
Leyh Pharma GmbH Overview
Leyh Pharma GmbH, based in the Schmalkalden-Meiningen district in Thuringia, is a German pharmaceutical company with a clear focus on the production and distribution of medicines and pharmaceutical products. The strategic location in the Thuringian Rhön region allows the company to benefit from the rich tradition and innovative spirit of the area. Leyh Pharma is not just active in Germany, but also has international collaborations that lead to the distribution of its products outside Germany.
Field of Activity and Products
Leyh Pharma GmbH produces and distributes medicines and medical products in accordance with the strict quality standards of the German Medicines Act. The company holds several pharmaceutical manufacturing licenses, enabling it to produce various medicines. The product range includes, among others:
- Human Medicines: A variety of tablets, capsules, and liquid medicines used to treat common diseases.
- Generics: Imitation products offered after the patent protection for original products expires to ensure affordable therapy.
- Medical Specialty Products: Products to support specific therapeutic areas, including pain therapy and oncology.
In production, there is a special emphasis on compliance with current GMP standards (Good Manufacturing Practice). Leyh Pharma also places a high value on quality assurance and control to ensure patient safety through carefully tested products. The company supplies not only pharmacies and medical institutions in Thuringia but also has a nationwide distribution that ensures the availability of its products throughout Germany.
Regulatory Classification
As a pharmaceutical company, Leyh Pharma is subject to strict regulatory requirements. This includes permits for the manufacture, modification, and marketing of medicines. Compliance with regulations is regularly checked by the responsible state office for health and district hygiene. Leyh Pharma adheres to European directives as well as the provisions of the Medicines Act, thereby ensuring the legal compliance of its production facilities.
Regional Significance and Influence
Thuringia has established itself as an important location for the chemical-pharmaceutical industry, and Leyh Pharma plays a significant role in this. The region is characterized by a medium-sized industrial structure, in which companies like Leyh Pharma contribute decisively to economic stability and job creation. In particular, the exchange with scientific institutions, such as the Friedrich Schiller University Jena and the Leibniz Institute for Natural Product Research and Infection Biology, enables Leyh Pharma to drive research and development and offer innovative solutions for patients. The close collaboration between industry and science promotes the innovative strength of the region and secures the long tradition of the pharmaceutical industry in Thuringia.
Particularities and Challenges
Leyh Pharma faces, like many companies in the industry, challenges caused by rapid technological progress and increasing demands for quality and transparency. To remain competitive, the company continuously invests in modern technologies and production processes. The strategic focus on research and development is another indication of how Leyh Pharma not only reacts to current developments but actively works to shape the future of pharmaceutical supply.
More information: Pharmaceutical companies in Thuringia or all pharmaceutical companies in Germany on Sanoliste.
```Frequently asked questions about Leyh Pharma GmbH
What does Leyh Pharma GmbH do?
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Pharmaceutical Companies in Germany
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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.