Krka's new Development-Control Centre 4 expands the company's capabilities for developing and assuring the quality of its innovative generic products

4. 10. 2019

The growth of Krka sales depends largely on new products, which are the result of Krka's own R&D. The products Krka began marketing over the past 5 years represent 29% of total sales; it, therefore, comes as no surprise that the company should expand its R&D capabilities. Krka is aware that the rapid advances in science and technology, coupled with increasingly more demanding markets, require continuous investment in equipment and know-how in order to launch products to the market in time and preserve the highest possible quality of company portfolio. Works on the new Centre began in July 2015 at Krka's central location in Ločna near Novo mesto. RKC 4 stands in the immediate vicinity of the other three Development-Control Centres, all forming a whole.

The purpose and advantages of RKC 4

This EUR 55.6 million investment allowed the company to acquire control-analytical laboratories and expand the facilities of the Pharmaceutical Development and Analytics Development departments. The new Centre covers 18,000 m2 of usable surface and extends over eight storeys. Krka received the operating permit in September 2018. In 2019, state-of-the-art laboratory, analytical and technological equipment was installed into the new Centre, allowing a more in-depth research work in the initial stages of product development.

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The facilities of the new Pharmaceutical Development Pilot Plant represent an important new addition. The Plant is intended for the development of solid pharmaceutical forms, which are a key part of new product development. The first part of the facilities contains rooms with technological laboratory equipment intended for R&D work. The second part contains semi-industrial equipment intended for clinical trial batches and stability testing, as well as optimising the technologies prior to their transfer to the industrial scale. State-of-the-art technological equipment is supported with in-process analytical techniques, which allow researchers to have a direct insight into the development and production of medicines. The new facilities and equipment will, already at the laboratory scale, make our development-research tests even more advanced. We will be able to define the product's key features that are essential for developing high-quality, safe and effective medicines already in the early stages of development. The semi-industrial equipment will allow the company to develop technological procedures and processes that will contribute to a faster transfer to the industrial scale.

The surface covering 4,700 m2 was designated for additional capabilities that will be used in laboratory quality testing. The modern, open-type laboratories were designed with Krka's own technical solutions, allowing work optimisation. High-quality analytical equipment features more than 300 instruments and testing devices, enabling efficiency and data integrity. Control laboratories represent a legal requirement, while at the same time ensuring independence and flexibility. In the building phase, the high level of employee protection, work safety (equipment, rooms) and environmental care (collection of wastewaters and solvents, waste separation) was taken into consideration.

The new RKC 4 is connected to RKC 3 with a bridge, which in turn is connected to RKC 1. The new Centre features state-of-the-art laboratory, analytical and technical equipment, allowing the company to nearly double its developmental and control-analytical capabilities as well as significantly upgrade its R&D, which is the pillar of Krka's vertically integrated business model.

Vertical integration is a key advantage of Krka's developmental strategy and quality

Krka controls the entire cycle of its products with a vertically integrated business model, which is the foundation for managing patent, developmental, legal, production and market requirements. APIs are synthesised according to Krka's own innovative procedures, while innovative pharmaceutical forms are produced with the use of the most sophisticated technology. More than 1,700 experts from more than 30 different natural science and engineering disciplines work together in pharmaceutical development, which is based on Krka's own know-how and innovation. Appropriate adaptation of Krka's developmental activities, union of developmental and production activities and the understanding of regulatory and market requirements enable the company to introduce new innovative generic pharmaceutical products and strengthen its competitive edge in more than 70 markets around the world.

In all developmental and production phases Krka pursues the highest international pharmaceutical standards and Good Production Practice guidelines. Krka performs numerous laboratory tests and analyses to ensure the high quality, safety and efficacy of its products, which is further demonstrated by extensive clinical trials the company performs. Krka monitors its products throughout the product's entire life cycle. Proper labelling ensures perfect traceability of the product from production to the patient.

Krka ensures its vertically integrated model of development on several levels with investment and R&D results:

• At the level of medicines and therapeutic areas by entering new therapeutic areas with new medicines and providing for their research, development and evaluation, as well as preparing new combinations of active ingredients with the patient in mind. The company aims to achieve the same therapeutic effect with lower concentrations of ingredients and reduce the number of daily doses at the same time.
• At the level of Krka's own active ingredients where innovative preparation procedures and new synthesis routes are introduced;
• At the level of pharmaceutical dosage forms by preparing advanced pharmaceutical dosage forms that allow for easier dosage and administration;
• At the level of research and development capacities by introducing the most advanced development and technological processes.

The vertically integrated business model enhances flexibility and increases the degree of innovation. Krka complements its leading therapeutic areas with key molecules and seeks innovative approaches and technological solutions for new therapeutic areas. This is why the company can develop medicines in pharmaceutical forms and strengths that are not yet available in the market, recognise the differences between various markets and at the same time provide more suitable treatment to the patients. Doctors and patients can choose among various advanced pharmaceutical dosage forms, strengths and single-pill combinations of active substances.

Over the past decade, Krka launched more than 40 new generic pharmaceutical products to the market as the first company to do so. This is achieved with analytical monitoring of the industry, Krka's own development and uniting know-how in the development of the API with the pharmaceutical form itself, advanced evaluation technologies, accurate planning of trials and a well-formed registration strategy. The know-how, experience and the dedication of Krka experts are of key importance.

Krka is committed to quality. Vertical integration of quality - with the help of know-how, experience, product development over the entire life cycle and the attitude of employees towards the quality of processes and products - ensures the safety, efficacy and quality of Krka products.

Krka's stable quality system is ensured by highly professional experts from various disciplines, who continuously upgrade the company's quality system, respond to legal and regulatory requirements in all the markets where we sell our products in a timely fashion, and by the dedicated work of Krka employees which is always in line with relevant pharmaceutical legislation and marketing authorisation requirements.

Did you know?

• Krka allocates 10% of its revenues to research, product development and new technologies.
• There are currently more than 170 on-going research projects for new products at Krka.
• Krka's medicines are used to treat over 50 million patients every day.
• The Krka Group achieves 29% of its sales with new products, i.e. the products launched over the past 5 years.
• Krka's is one of the leading generic producers of medicines for lowering high blood pressure and cholesterol levels, medicines for treating ulcer and reflux diseases, and medicines for treating depression. The company offers a wide range of medicines for treating various types of psychoses, Alzheimer's and Parkinson's diseases, painkillers and other medicines.
• Krka was the first company in Europe to offer a triple-pill combination in one product (perindopril, indapamide, amlodipine) made from three groups of medicines used in the treatment of elevated blood pressure levels.
• Krka's modern R&D laboratories employ 187 researchers with a doctoral degree and 382 researchers with a master’s degree or specialisation - many of them received numerous Slovenian and international awards.
• Krka has obtained patent protection for more than 350 of its innovations in Europe, North America and Asia.