How are medicines manufactured? From idea to patient It is a long way before a given medicine is available for our patients. Sometimes it takes decades! It usually begins with an idea for a new product, a long period of research, through to tests, the production and distribution of the new medication. Today’s drugs usually result from the work of a number of research teams in our centres across the world. The next stage involves certification of the drug, meaning that the drug is formally approved for sale. This can very often last even a few years. The experience of Gedeon Richter’s specialists and the state‑of-the-art technology that we use make it possible for us to minimise this period, which benefits our patients.
" alt=""> The idea It is the patients, their needs and their health that inspire us to develop new therapies. Each work cycle begins from the design team, in which specialists from various fields join together to build the concept of a new drug.
" alt=""> Research and technology The next stage of the works on a new pharmaceutical product is performed by the research and development team. Our laboratories develop alternative forms of a given product and methods for assessing its quality. The results of the research are sent to the technological team which prepares the drug for production. This period is preceded by long-term research on the efficacy of such new medication. It is at this very moment that we also check its effects on the entire body, not just the pathologically changed sites, as well as its interactions with other drugs and the potential adverse reactions. All process is dependent from the supreme joint efforts and time consuming clinical trials, not to mention the final EU authorities’ approval.
" alt=""> Medicine registration The drug registration procedure requires huge experience and knowledge of multiple international regulations. This stage is the responsibility of Gedeon Richter’s Drug Registration Department. The documentation of concerning the new medicine is submitted to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
" alt=""> Production After obtaining the so-called product record, the product in question can be launched in the market. The production process takes place in batches, with each being subject to detailed quality control procedures. Throughout the drug’s production cycle, data concerning the quality parameters of the particular batches are gathered and the production processes themselves are continuously streamlined.
" alt=""> Quality The quality and safety of our drugs are of utmost importance for us. We carefully and conscientiously fulfil all the requirements of the Good Manufacturing Practice (GMP). Our products are awarded with the GMP Certificate, which confirms that they comply with all the requirements in order to be approved for sale, without putting patients at any risk related either to their application or inefficiency.
" alt=""> Distribution When the drug is ready, it waits in a warehouse for marketing authorisation. It is stored in optimal conditions and monitored 24 hours a day. After successfully passing the last qualitative tests and receiving a qualified assessment, a batch of the medication is launched in the market. The quality of our products is controlled throughout their shelf-life and each batch leaving the production line is archived.
Global medical projects Gedeon Richter, as an international pharmaceutical group, allocates around 110 million euro a year to research and development of modern pharmaceutical products. Our development strategy puts us amongst one of the top European drug producers. The research activities of Gedeon Richter are focussed on three areas: - the development of original medicines; - the production of biotechnological preparations; - the improvement of generic products. Our original research efforts to seek cutting-edge drugs are primarily focused on combating the diseases of the central nervous system related to cognitive disorders, autism, migraines and obesity. We attach particular importance to development works on gynaecological drugs. Our latest innovative product in this field is the drug used in the management of uterine myomas. A special line of products is also dedicated to pregnant women. The legitimacy of our strategy is supported with each new drug launched in the market. This is the best proof that the investments in research and development as well as in young talented employees are an excellent recipe for the health of our patients.
Therapies of the future Working over research projects now, we think about the therapies of the future. Biotechnology, when combined with today’s technical possibilities, opens up new horizons for medicine and pharmacology. It gives hope to many patients that their diseases, so far regarded as incurable, can be successfully overcome. Gedeon Richter has been participating in these works for over 50 years, making biotechnology one of the strategic pillars of the company . We specialise in the field of experiences acquired in classical fermentation and advances in molecular biology, the company took a decision in 2006 to begin to develop and manufacture biotechnological drugs. Besides research projects, we also invest in developing the production of these preparations, as illustrated by the modern production plant opened in Debrecen in 2012 and a joint venture in Germany.
Several R&D centers By combining the various specialist experiences, we are able to better understand the needs of our patients. The research teams of Gedeon Richter work in Hungary, while we have development staff in Switzerland, Germany, Poland, and Romania. We are present on five continents and in over 45 countries worldwide. Our worldwide laboratories are equipped with state-of-the-art research equipment and facilities that make it possible for us to work on the innovative drugs of the future. For a few years, Gedeon Richter has been intensively involved in the works on biotechnologies. The company’s goal is to create a comprehensive and competitive product line that can help to expand its domestic and international product portfolios with high added value products. The two target therapeutic areas are oncology and immunology. Richter’s original drug research traditionally concentrates on discovering and developing effective drugs to combat diseases of the central nervous system. Our current focus in proprietary research is on the development of compounds for the treatment of cognitive disorders, autism, migraine and obesity. Each year we allocate approx. 10 percent of our revenue to R&D. In Poland, we are primarily focused on modern production technologies, the development of analytical methods, the performance of clinical research and the registration of medicinal products. We also supervise the entire monitoring system ensuring the safety of pharmacological therapies.