Generic medicines are the equivalent of originator medicines whose patent protection has either expired or of those that never had one. Generic medicines contain the same active pharmaceutical ingredients as the original pharmaceuticals. Generic pharmaceuticals are also equivalent to the originator medicines in terms of quality, efficacy and safety. This has been confirmed by therapeutic practice, market authorisation documentation and bioequivalence research. Generic pharmaceuticals are also increasing in importance around the world because they offer the same quality and are an acceptable alternative form of treatment compared to originator medicines.
In terms of strategy, Krka is primarily a generic pharmaceutical company. We develop and market generic products with added value, i.e. high quality products at accessible prices that have made Krka a recognisable name in many parts of the world.
Our generic pharmaceuticals are based on our own innovative procedures for synthesising or isolating active pharmaceutical ingredients and our own innovative pharmaceutical formulations. Today, we have over 350 patent protected innovations for which numerous patents have been issued in various European, American and Asian countries.
API quality is verified via extensive laboratory testing using the most sensitive, reliable and validated analytic methods and devices. Given the improvements in synthesis and evaluation processes, generic APIs can be of an even higher quality that the API of the original producer.
The Certificate of Suitability (CoS) issued by the European Directorate for the Quality of Medicines (EDQM) is the highest quality standard in Europe. It confirms that an API meets European pharmaceutical standards. Krka has obtained this certificate for a number of APIs.
A Krka generic pharmaceutical is equivalent to the originator products. Pharmaceutical equivalence is confirmed by in vitro release tests, and therapeutic equivalence throughin vivo testing and bioequivalence research. In both cases Krka pharmaceuticals are directly compared to those of an original pharmaceutical producer.
The efficacy and safety of Krka products is also regularly verified and confirmed in practice. Extensive clinical trials form part of the pre-registration (phase III) as well as the post-registration research process (phase IV) and pharmoequivalence work.