Acis Arzneimittel GmbH
Pharmaceutical Companies · München
Acis Arzneimittel GmbH is a pharmaceutical company based in München, Bavaria, 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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Acis Arzneimittel GmbH Address & Contact
Acis Arzneimittel GmbH at a Glance
Acis Arzneimittel GmbH from Munich is a pharmaceutical company specialized in generics in Bavaria and part of the international Teva Group, the world's largest generic medicine manufacturer. With a clear focus on availability and quality, Acis is known in the German pharmacy market as a reliable quality provider. The company aims to sustainably improve healthcare for the population by providing cost-effective, high-quality medicines.
Services and Products
The portfolio of Acis includes generics in all important indication areas, including cardiovascular, neurology, oncology, and infectious diseases. These medicines are often indispensable for the treatment of chronic diseases, lengthy therapies, and acute illnesses. The preparations are available at significantly lower prices than original medicines and are preferred for aut-idem substitutions by pharmacists. Exemplarily, the products for the treatment of hypertension and cholesterol reach a large number of patients. All products are manufactured in GMP-certified facilities and comply with the requirements of the European Pharmacopoeia.
- Cardiovascular Diseases: Acis offers a variety of active ingredients for the treatment of hypertension and arrhythmias.
- Neurological Diseases: The range includes generics for the treatment of epilepsy, Alzheimer's, and multiple sclerosis.
- Oncological Therapy: Acis markets generics to support cancer therapy, which are vital for many patients.
- Infectious Diseases: Antibacterial and antiviral medications are also part of the product portfolio and are recommended in numerous treatment guidelines.
Regulatory Classification
Acis Arzneimittel GmbH operates within the strict regulatory framework of the European market. The medicines are approved by the Federal Institute for Drugs and Medical Devices (BfArM) and are subject to regular inspection by medicinal products supervisory authorities. Quality standards are ensured by Good Manufacturing Practice (GMP), which guarantees safe and effective production. Additionally, the company adheres to the guidelines of the EMA (European Medicines Agency) to ensure the safety and effectiveness of its products throughout Europe.
Location Munich / Bavaria
Munich is one of the most important pharmaceutical company locations in Germany and Europe. Acis's branch in the Bavarian capital benefits from excellent infrastructure, a dense network of pharmaceutical service providers, and a qualified workforce in the region. Proximity to renowned research institutions and universities enables Acis to continuously invest in innovations and adapt to developments in drug therapy. The strategic location not only ensures quick access to raw materials but also effective logistics to meet market needs promptly.
Special Features of the Company
A special feature of Acis Arzneimittel GmbH is its focus on sustainability and the promotion of ecological projects. The company actively advocates for environmentally friendly production methods by implementing energy-efficient processes and promoting the use of resource-saving materials. Furthermore, Acis engages in various health initiatives in the community to improve awareness of generic medicines and their benefits for patients. This socially responsible corporate policy contributes to strengthening its image and acceptance among pharmacists and patients alike.
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Frequently asked questions about Acis Arzneimittel GmbH
What does Acis Arzneimittel GmbH do?
Acis Arzneimittel GmbH is a pharmaceutical company based in München that develops, manufactures or distributes pharmaceutical products. The company is active in the German healthcare market.
Where is Acis Arzneimittel GmbH located?
Acis Arzneimittel GmbH is headquartered in München, Germany. More information can be found on the company's website.
What products does Acis Arzneimittel GmbH distribute?
Acis Arzneimittel GmbH is active in the pharmaceutical sector. Detailed information on the products offered and therapeutic areas can be found on the company's website or via the contact details provided.
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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.