Analytical techniques and research
We perform analytical research and evaluations throughout development to ensure that our products reflect the highest quality standards. We apply the same quality standards to our entire development process, from raw ingredients to finished products.
Analytical methods resulting from our own innovations and knowledge are at the heart of the development and later life cycle of APIs and finished products. They help us obtain information critical to development and quality control. We use them to ensure the quality of all raw materials, bulk, intermediate, and finished products in all R&D and production phases and to demonstrate quality when a product is released on the market.
We continuously upgrade our analytical knowledge and introduce various new analytical techniques and methodologies, an integral part of which includes cooperation with institutes, universities and specialised companies.
Modern analytical techniques help us develop the most advanced generic products with added value, and these are the products that we enter markets with as the first generic manufacturer. We manufacture products comparable to the originator’s in many quality parameters, often surpassing them.
State-of-the-art analytical techniques
Our state-of-the-art equipment allows us to use advanced analytical techniques which support the most demanding development projects. We can determine and evaluate key parameters defining our products’ safety, quality and efficacy.
Using in vitro evaluation of API release, we ensure appropriate in vivo release and optimal action of our medicinal products. Microscopic and spectroscopic analyses give us an insight into the core of the manufactured medicinal product at the nanometre level, allowing us to observe the individual building blocks that form our products. Using the most advanced chromatographic techniques, we can cover the entire spectrum of orders of magnitude, from API content determination to detecting impurities and traces at the parts per billion level. API concentrations in biological materials are evaluated in a state-of-the-art bioanalytical laboratory.
We maintain the strictest safety margins to ensure our APIs and finished products are of the highest purity. We follow international guidelines and utilise the knowledge of our experts, who have years of experience in this field. Taking into consideration the ethical aspects of the development of medicinal products, we perform in silico and in vitro analyses and, in doing so, avoid animal studies (in vivo toxicology studies).
During Krka’s intensive development and growth, we constructed and equipped four product development and quality control facilities and laboratories spanning over 30,000 m2. These premises house research and development capacities related to APIs and pharmaceuticals. Over 800 experts are involved in the development of medicinal products at Krka.
In our commitment to healthy living we offer a broad range of high-quality prescription pharmaceuticals, non-prescription medicines and animal health products.