Roja Pharmazie GmbH
Pharmaceutical Wholesale · Berlin
Roja Pharmazie GmbH is a pharmaceutical wholesaler based in Berlin, Germany.
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Roja Pharmazie GmbH Address & Contact
Roja Pharmazie GmbH Overview
Roja Pharmazie GmbH was founded in 2005 in Berlin. With the goal of ensuring a reliable supply of medicines and pharmaceutical products, the company has quickly made a name for itself in the industry. It supplies not only pharmacies and hospitals in Berlin but also in the surrounding Brandenburg region. As an authorized wholesaler according to § 52a of the Medical Products Act (AMG), Roja Pharmazie meets the stringent requirements of German pharmaceutical regulation, thereby ensuring the quality and safety of the supplied products.
Services and Products
The product portfolio of Roja Pharmazie GmbH includes a variety of human medicines, both prescription and over-the-counter (OTC) products. Particularly noteworthy is the specialization in pharmaceutical products for hospital supply. The efficient and safe delivery of these products is especially important for patient care in clinics. The company employs state-of-the-art technologies to ensure an uninterrupted cold chain, allowing temperature-sensitive medications to be stored and transported under optimal conditions. The storage and delivery of the preparations are carried out in accordance with the guidelines of Good Distribution Practice (GDP) to guarantee the highest quality standards.
Location Berlin / Berlin
Berlin, as the federal capital and largest city in Germany, represents a significant pharmaceutical market. The combination of top-notch research facilities and a variety of high-profile clinics, such as Charité and Vivantes, creates a dynamic environment for pharmaceutical wholesalers. Additionally, there is a high density of pharmacies in Berlin that rely on reliable delivery of medicines. Roja Pharmazie not only benefits from this flourishing market but also makes an important contribution to the healthcare provision of the region. Through close partnerships with medical institutions, the company can flexibly respond to the needs of its customers and ensure that medicines are provided promptly and efficiently.
Particularly noteworthy is the commitment of Roja Pharmazie GmbH to sustainable development. The company pursues an environmentally conscious logistics strategy to minimize its ecological footprint. This includes optimizing transport routes and using environmentally friendly packaging materials. These measures underscore not only the company’s responsibility towards the environment but also towards the society in which it operates.
Regulatory Classification
Roja Pharmazie GmbH is not only authorized under § 52a AMG but also in accordance with the relevant European directives for the wholesale of medicines. This requires regular inspections and audits to ensure compliance with high quality standards. Furthermore, the company is registered in the database according to § 67 of the Medical Products Act, which improves traceability and transparency in the supply chain. Ensuring safety and quality is the highest priority for Roja Pharmazie, with continuous training and further education for employees also being part of the company's philosophy.
In addition to the legal requirements, the company is also committed to the training of its employees and the promotion of an excellent working environment. To this end, regular training sessions on current developments in pharmacy and logistics are offered to ensure that all employees are always up to date.
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Frequently asked questions about Roja Pharmazie GmbH
What is Roja Pharmazie GmbH?
Roja Pharmazie GmbH is a pharmaceutical wholesaler based in Berlin. The company supplies pharmacies, clinics and other healthcare facilities with medicines and pharmaceutical products.
What products does Roja Pharmazie GmbH distribute?
As a pharmaceutical wholesaler, Roja Pharmazie GmbH supplies pharmacies and healthcare facilities with prescription and over-the-counter medicines, medical devices and other pharmaceutical articles to GDP standards.
How can I contact Roja Pharmazie GmbH?
You can reach Roja Pharmazie GmbH using the contact details provided on this page. More information can be found on the company's website.
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About Pharmaceutical Wholesale
Pharmaceutical wholesalers (Pharmagrosshandel) form the critical supply chain link between medicine manufacturers and authorised recipients such as pharmacies (Apotheken), hospitals (Krankenhäuser), medical practices and other licensed healthcare facilities. In Germany, the commercial distribution of medicinal products at wholesale level is a strictly regulated, licence-dependent activity. Every pharmaceutical wholesaler must hold a wholesale dealer authorisation (Großhandelserlaubnis) granted under Section 52a of the AMG (German Medicinal Products Act). This authorisation is issued by the pharmaceutical supervisory authority of the relevant German federal state and requires applicants to demonstrate suitable temperature-controlled storage premises, a documented quality management system, a qualified responsible person (verantwortliche Person), and ongoing compliance with the EU Good Distribution Practice (GDP) guidelines. Full-line wholesalers (Vollsortimenter) stock virtually the entire range of authorised medicines available in Germany, whereas specialist wholesalers focus on particular therapeutic areas or logistics requirements such as cold chain products, controlled substances (Betäubungsmittel) or imported parallel-trade medicines. Nationwide, around 15 full-line wholesalers and over 100 specialist wholesalers collectively ensure comprehensive medicine supply to more than 18,000 pharmacies across the country. This directory lists all authorised pharmaceutical wholesalers in Germany holding a valid authorisation under Section 52a AMG, with addresses and full contact details.
The Role of Pharmaceutical Wholesale in Germany's Medicine Supply
Germany's pharmaceutical wholesale sector is the backbone of the country's medicine distribution system, ensuring that more than 18,000 pharmacies and thousands of hospitals receive their medicine supplies reliably, often within hours of ordering. The German wholesale model is built around a hub-and-spoke logistics system: large national full-line wholesalers (Vollsortimenter) operate central and regional warehouses that stock virtually the entire range of authorised medicines. From these warehouses, medicines are delivered to pharmacies typically two or three times per day by refrigerated vans. This high delivery frequency means that pharmacies can operate with lean stock levels while still being able to fill patient prescriptions on the same day. Germany's medicine supply chain performed robustly during the COVID-19 pandemic, demonstrating the resilience of its wholesale infrastructure. The three largest full-line wholesalers in Germany collectively hold a dominant market share, but they compete with each other and with smaller regional and specialist wholesalers.
Legal Requirements Under Section 52a AMG and EU GDP
Operating as a pharmaceutical wholesaler in Germany requires a wholesale dealer authorisation (Großhandelserlaubnis) granted by the competent pharmaceutical supervisory authority of the relevant German federal state under Section 52a of the AMG. This authorisation is not automatic and requires applicants to demonstrate compliance with a detailed set of prerequisites before trading can begin. The premises must be suitable for temperature-controlled storage, with validated temperature mapping studies for all storage areas. A documented quality management system (QMS) must be in place covering procurement, storage, pick and dispatch, complaints, returns, recalls, counterfeiting detection and self-inspections. A qualified responsible person (verantwortliche Person) with the relevant pharmaceutical or scientific qualifications must be designated and approved by the authority. After authorisation is granted, companies must comply with the EU GDP guidelines (EudraLex Volume 5), which are periodically updated. Inspections by the state pharmaceutical authority verify ongoing compliance.
Specialist Wholesale and Cold Chain Logistics in Germany
Beyond full-line wholesale, Germany has a developed specialist wholesale sector catering to specific product categories that require particular expertise or infrastructure. Cold chain wholesale is especially important for biological medicines including monoclonal antibodies, vaccines, insulin and plasma-derived products, which must be stored and transported within defined temperature ranges (typically 2 to 8 degrees Celsius). Controlled substance (Betäubungsmittel) wholesale requires additional authorisation under the Betäubungsmittelgesetz (BtMG) and is subject to strict record-keeping and security requirements. Import wholesale specialises in parallel-imported medicines, sourcing products authorised in other EU member states at lower prices and relabelling them in accordance with German regulatory requirements. Specialty pharmacy wholesale focuses on high-value oncology drugs, immunosuppressants and rare disease treatments. Each of these specialist segments requires specific expertise, infrastructure and additional regulatory permissions beyond the standard Section 52a AMG authorisation.
Medicinal Product Supply Chain Security and Falsification Protection
The integrity of the pharmaceutical supply chain is a central responsibility of pharmaceutical wholesale. Since February 2019, the EU Falsified Medicines Directive (FMD) has been fully in force: every prescription medicinal product pack carries an individual 2D data matrix code, which is scanned and verified at the wholesaler and end recipient in the national verification database (in Germany: securPharm). Temperature-critical products, including biologics, insulins and vaccines, require an unbroken cold chain (2–8 °C or frozen), which the wholesaler ensures with validated cold stores, temperature-controlled transport and temperature monitoring. Controlled substances are additionally subject to the Narcotics Act (BtMG) with strict documentation requirements. Recall management and batch traceability in accordance with GDP guidelines are mandatory. Sanoliste identifies specialist wholesalers for cold chain, controlled substances and parallel import medicines separately.
What does a pharmaceutical wholesaler do?
Pharmaceutical wholesalers procure, store and distribute medicines to pharmacies, hospitals and other authorised recipients. In Germany, wholesale trade in medicines requires authorisation under Section 52a AMG.
What authorisation does a pharmaceutical wholesaler need?
A pharmaceutical wholesaler must hold authorisation under Section 52a of the AMG (German Medicinal Products Act). Requirements include suitable premises, a qualified responsible person and compliance with EU Good Distribution Practice (GDP) guidelines.
How do I find an authorised pharmaceutical wholesaler in Germany?
Authorised pharmaceutical wholesalers are registered with the competent state authority under Section 52a AMG. Sanoliste lists all wholesalers with valid authorisation, including specialisations in cold chain logistics, controlled substances or imported medicines. Filter by federal state for a regional search.
How many pharmaceutical wholesalers are there in Germany?
Germany has approximately 15 full-line pharmaceutical wholesalers (Vollsortimenter) that stock the full range of authorised medicines and deliver to pharmacies nationwide, alongside more than 100 specialist wholesalers focusing on specific therapeutic areas, temperature-sensitive biologics or controlled substances. Together they supply over 18,000 pharmacies across the country.
What does EU Good Distribution Practice (GDP) require?
The EU GDP guidelines (2013/C 343/01) set out requirements for the proper distribution of medicinal products. For pharmaceutical wholesalers this includes maintaining appropriate temperature-controlled storage conditions (especially for cold-chain products), operating a documented quality management system, training qualified personnel, conducting supplier and customer qualification audits, maintaining full traceability records, and having procedures for handling suspected counterfeits, complaints and recalls.
Can a pharmaceutical wholesaler in Germany supply directly to patients?
No. In Germany, pharmaceutical wholesalers are not permitted to supply medicines directly to patients. They may only supply authorised recipients such as pharmacies, hospitals, medical practices (under specific conditions) and other licensed wholesalers. Patients must obtain prescription medicines through a pharmacy, which in turn sources its stock from authorised wholesalers or directly from manufacturers.
What is the difference between a pharmaceutical wholesaler and a medicine broker?
A pharmaceutical wholesaler physically holds medicines in stock, stores them and delivers to authorised recipients such as pharmacies and hospitals. They require a wholesale authorisation under § 52a AMG and must maintain GDP-compliant storage conditions. A medicine broker, by contrast, does not take possession of medicines but merely arranges transactions between manufacturers, wholesalers and buyers. Brokering activities are subject to registration under § 52b AMG.