Organon Healthcare GmbH
Pharmaceutical Companies · München
Organon Healthcare GmbH is the German subsidiary of Organon & Co, based in München.
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Organon Healthcare GmbH Address & Contact
Company profile
2021
Founded
10.000+
Employees
Organon Healthcare GmbH at a Glance
Organon Healthcare GmbH is the German subsidiary of Organon & Co., an independent pharmaceutical company spun off from Merck & Co. in 2021. Organon focuses on women's health, biosimilars, and established brands. The subsidiary is based in Munich and plays a central role in the German pharmaceutical market, particularly in supporting medical professionals and providing care for patients.
Women's Health and Biosimilars
Organon is known in Germany for its extensive portfolio of women's health products, which includes hormonal contraceptives such as NuvaRing and Cerazette, as well as fertility therapeutics like Puregon. The fertility medications are specifically developed to assist couples in family planning. Additionally, the company offers hormone replacement therapies that play a significant role during the menopause phase. The biosimilars segment covers important immunotherapies, as Organon distributes biosimilars for medications such as Adalimumab and Etanercept, which are used to treat autoimmune diseases.
The portfolio also includes established brands such as Singulair, Zocor, and Arcoxia, which have proven effective in the treatment of respiratory diseases as well as cardiovascular conditions. This diversification allows Organon to be active in various therapeutic areas, thus providing comprehensive support to both doctors and patients.
Regulatory Classification
As an active pharmaceutical company, Organon Healthcare GmbH is subject to strict regulatory requirements. The company conducts all activities in accordance with the guidelines of the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM). These regulatory authorities are responsible for the approval of new medications as well as for monitoring the safety and efficacy of already approved products. Furthermore, Organon is committed to transparency and ethical standards in clinical research and marketing of its products.
Location Munich
From Munich, Organon Healthcare GmbH supports gynecologists, reproductive medicine specialists, rheumatologists, and general practitioners in Germany. Munich, as a pharmaceutical location, provides Organon with a strong network in the German medical community. The region is not only a center for biomedical research but also attracts highly qualified professionals from the pharmaceutical and healthcare industries. This enables Organon to establish local collaborations for the further development of innovative therapies and to conduct clinical studies in cooperation with leading research institutions.
Additionally, the Munich location influences Organon's sales strategy across the entire German market. The close networking with medical professional societies promotes the exchange of information about new developments in gynecology and the treatment of chronic diseases, ensuring quick access to the latest medical insights and treatment options for doctors and patients.
Company Specialties
A special feature of Organon is its focus on innovations in women's health. The company continuously invests in research and development projects specifically focused on the needs of women. This includes the development of new products and therapies tailored to the various life stages of women. Organon values patient-oriented research and development, which is reflected in efforts to integrate feedback from patients and medical professionals into the development process.
Moreover, Organon is involved in various social projects related to women's and health policies. The company supports campaigns to raise awareness about women's health issues and promotes programs that enhance awareness of gynecological diseases. Thus, Organon contributes not only to medical care but also to the societal improvement of health awareness.
More pharmaceutical companies in Germany | pharmaceutical companies in Munich | pharmaceutical companies in women's health
```Frequently asked questions about Organon Healthcare GmbH
What does Organon Healthcare GmbH do?
Organon Healthcare GmbH is in den vier Produktionsbereichen Frauengesandheit, Fertilität, Biosimilars and etablierte products tätig. Die etablierten products beziehen sich on Atemwegserkrankungen, Herz-Kreislon-Beschare and Schmerztherapie. Medikamentöse Unterstützung at Kinthewunsch and spezifischen Frauenleiden, sowie günstigere Abgabe of medicines durch Biosimilars steht im weiteren Programm des companys.
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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.