Nordmark Pharma GmbH
Pharmaceutical Companies · Pinneberg
Nordmark Pharma GmbH is a pharmaceutical company based in Pinneberg, Germany.
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Nordmark Pharma GmbH Address & Contact
Nordmark Pharma GmbH Overview
Nordmark Pharma GmbH, based in Pinneberg, Schleswig-Holstein, is one of the established companies in the German pharmaceutical industry. For several decades, Nordmark has focused on the development and manufacturing of biological drugs as well as the extraction of substances from animal tissues. As one of the oldest manufacturers of pancreatic enzymes and gastrointestinal preparations, Nordmark is known both nationally and internationally for its high-quality biological drugs. Through extensive research and development activities, the company ensures that it continuously provides innovative solutions to the medical challenges of its time.
Services and Products
Nordmark Pharma produces a variety of specific product groups, including pancreatic enzyme preparations such as pancreatin, which is primarily used in the treatment of exocrine pancreatic insufficiencies. The production of insulin preparations is another essential business area that includes both human and veterinary medical applications. Additionally, Nordmark focuses on the development of innovative biological drugs from animal-sourced materials, including complex biological active substances.
The company has state-of-the-art extraction and purification facilities that operate according to strict regulatory standards. Nordmark adheres to Good Manufacturing Practices (GMP), ensuring the quality and safety of its products. In addition to its own product range, Nordmark also operates in the contract manufacturing sector, offering the production of biological preparations to external customers. This allows other pharmaceutical companies to benefit from Nordmark's expertise and technological capabilities.
Regulatory Classification
As a pharmaceutical company, Nordmark is subject to strict regulatory requirements set at both national and European levels. The company is registered according to the Medicines Act (AMG) as well as the EU regulation on medicines for humans and animals. Compliance with these regulations is continuously monitored through internal and external audits, ensuring high patient safety and product quality. Furthermore, Nordmark continuously invests in the training of its employees to meet the constantly changing regulatory requirements.
Location Pinneberg / Schleswig-Holstein
Pinneberg is located in the Hamburg metropolitan area and represents a strategically advantageous location for Nordmark Pharma GmbH. The Schleswig-Holstein region is characterized not only by its proximity to the metropolitan region of Hamburg but also by a strong network of suppliers and research institutions that are significant for the pharmaceutical industry. This geographical location provides excellent logistical conditions that substantially support both the national and international distribution of biological drugs and pharmaceutical active substances. The optimal connection to transport routes and access to skilled workers from the region further contribute to the company's competitiveness.
Special Features and Innovative Power
Particularly noteworthy is the innovative strength of Nordmark Pharma GmbH. Through close cooperation with universities and research institutes, new biopharmaceutical developments are continuously pursued. This has resulted in Nordmark not only being able to further develop existing products but also to explore new therapy concepts. One of the company’s recent initiatives is the research in the field of personalized medicine, where specific therapies are developed based on genetic profiles.
Another remarkable aspect is Nordmark's strong commitment to sustainability. The company has already implemented several measures to minimize environmental impact during production. These include the use of renewable energies, the optimization of production processes, and the reduction of waste and emissions.
Other Pharmaceutical Companies: Pharmaceutical Companies Overview | Pharmaceutical Companies Schleswig-Holstein | Contract Manufacturers
Frequently asked questions about Nordmark Pharma GmbH
What does Nordmark Pharma GmbH do?
Nordmark Pharma GmbH stellt Wirkstoffe and medicines her with biologischem and biotechnologischen Ursprung. Führend is sie at the Produktion of Pankreatin and Kollagenase. Sie stellt zum einen for anthee Pharmaundernehmen her and disributes zum antheen the eigenen products selbst. Ebenso offers sie Beratung of the development bis zur Zulassung eines Medikaments or the komplette Durchführung the Wertschöpfungskette an.
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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.