Otsuka Pharma GmbH
Pharmaceutical Companies · Frankfurt am Main
Otsuka Pharma GmbH is the German subsidiary of japanischen Pharmaunternehmens Otsuka Pharmaceutical Co, based in Frankfurt am Main. Key areas: Psychiatrie (Abilify Maintena®), Onkologie, kardiovaskuläre und weitere Therapien.
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Otsuka Pharma GmbH Address & Contact
Company profile
1921
Founded
30.000+
Employees
Otsuka Pharma GmbH Overview
Otsuka Pharma GmbH is the German subsidiary of the Japanese pharmaceutical company Otsuka Pharmaceutical Co., Ltd., a research-oriented company distinguished by innovative solutions in the fields of psychiatry, neurology, and oncology. The German company is based in Frankfurt am Main, where it closely collaborates with various medical institutions and healthcare professionals. Otsuka Pharma stands out due to its research competence as well as its focus on the development of therapies in under-serviced areas of disease. Otsuka's global vision aims to improve patients' quality of life through innovative medications.
Psychiatry and Neurology
Otsuka is primarily known in Germany for the development and marketing of Abilify (Aripiprazole), which is considered one of the leading antipsychotics. Additionally, the company offers the long-acting formulation Abilify Maintena (monthly depot injection), which is approved for the treatment of schizophrenia and bipolar disorder. A highlight from Otsuka's product pipeline is Rexulti (Brexpiprazole), a novel antipsychotic gaining increasing importance due to its improved side effect profiles and high efficacy. Furthermore, Otsuka provides Jinarc (Tolvaptan), an important therapeutic option for patients with autosomal dominant polycystic kidney disease (ADPKD), a condition that is often inadequately treated. The company continuously and intensively researches new psychiatric treatment approaches, underscoring the innovative character of Otsuka.
Oncology
In addition to psychiatry and neurology, Otsuka also invests in oncology, where it develops innovative treatment approaches to improve cancer care. The research activities focus on therapies targeting specific genetic markers to enable targeted treatment of tumors. Otsuka has already celebrated successes in the development of medications that, through combination therapies in cancer treatment, meet the needs of new hopefuls. These efforts align with the company's global strategy to play a central role in providing comprehensive health solutions.
Regulatory Classification
Otsuka Pharma is subject to strict regulatory frameworks in Germany that govern the development and marketing of pharmaceutical products. Drug monitoring is ensured by authorities such as the Federal Institute for Drugs and Medical Devices (BfArM) and the European Medicines Agency (EMA). Otsuka has earned a good reputation through transparent processes and proactive communication with regulatory authorities. Compliance with Good Manufacturing Practices (GMP) and conducting clinical trials under ethical and scientific standards are of utmost priority for Otsuka.
Location Frankfurt am Main
From Frankfurt, Otsuka Pharma serves psychiatrists, neurologists, and nephrologists throughout Germany. The central location in Frankfurt as a finance and pharmaceutical hub offers Otsuka an excellent network within the German specialist medical community. Additionally, employees and partners benefit from proximity to important medical institutions and universities that provide a variety of collaboration opportunities. Otsuka actively engages in professional circles and conferences to promote dialogue between research and clinical practice.
Regional Importance and Characteristics
The significance of Otsuka Pharma for the Frankfurt am Main region is considerable. By creating jobs in research, development, and sales, the company contributes to the economic stability of the region. Otsuka is also committed to social responsibility and is involved in various local initiatives that serve the health and well-being of the population. Distinctive features such as the integration of ERM (Ethical Review Management) into research processes and partnerships with universities to promote new talents are characteristic of Otsuka's approach to advancing both social and medical innovations.
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Frequently asked questions about Otsuka Pharma GmbH
What does Otsuka Pharma GmbH do?
Otsuka Pharma GmbH develops Medikamente for the Bereiche Neurowissenschaft, Nephrologie, Hämatologie, Onkologie, Endokrinologie, Ophthalmologie, Herz-Kreislon- and Infektionserkrankungen; dazu Nahrungsergänzungswithtel. Die deutsche Niethelassung is with Vermarktung and distribution the medicines for den German Markt, sowie with the Erforschung neuer products for Europa betraut.
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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.