Generic medicines

Generic medicines are equivalents of original products the patent protection of which has expired or has not been sought. They contain the same active ingredients as the original products and are equivalent (equal) to their original counterparts in quality, safety and efficacy. In addition to the marketing authorisation documentation and the results of bioequivalence studies, their equivalence is supported by therapeutic practice.

The global importance of generic medicines is increasing, as they are of the same quality as the original products and thus offer an alternative to the treatment with original products, available at a more acceptable price.

Krka’s generic medicines with added value

The central element of Krka’s strategic orientation is the manufacture of generic medicines. We develop and market added-value generic products, that is, high-quality products at affordable prices, for which we are recognised across a considerable part of the world.

Krka’s generic medicines are based on our own innovative synthesis processes or processes for the isolation of active substances and on our own innovative pharmaceutical formulations. Today Krka has over 280 patent-protected innovations for which a number of patents have been issued in several European and Asian countries and in the USA.

The quality of our active substances is controlled by a number of laboratory tests using highly sensitive and reliable validated analytical methods and instruments. Owing to improved synthesis processes and evaluation methods a generic active substance may even be of a higher quality than that of the original producer.

The Certificate of Suitability (CoS) granted by the European Directorate for the Quality of Medicines (EDQM) is the highest quality standard in Europe. It confirms that an active substance complies with the standards of the European Pharmacopoeia. Krka has been awarded the EDQM Certificate of Suitability for a number of its active substances.

A medicine by Krka is equivalent to the respective original product. Its pharmaceutical equivalence is confirmed by in vitro dissolution tests and its therapeutic equivalence by in vivo bioequivalence studies. Both evaluation methods involve direct comparison between the Krka’s and the originator’s product.

The efficacy and safety of Krka’s pharmaceutical products are under continuous surveillance and confirmed in practice. Numerous clinical studies include preregistration (phase III), postmarketing (phase IV) and pharmacovigilance studies.

Prescription Pharmaceuticals