The European Directorate for the Quality of Medicines (EDQM) has granted Gnosis a certificate of suitability of the European Pharmacopoeia (CEP) for teicoplanin. The CEP certification provides proof that the quality of the substances used in human medicines is suitably controlled by the relevant monographs of the European Pharmacopoeia.
Teicoplanin is a true fermentation glycopeptide antibiotic produced by actinoplanes teichomyceticus strains and is a mixture of glycopeptide components which are currently classified into six main subcomponents known as a specific “Complex”.
The first application for a generic of the reference product was submitted in 2005 through the decentralized procedure (DCP). During the teicoplanin assessment, it was discovered that the compositional profile of glycopeptide subcomponents present in the generic version differed compared to the originator. As the composition of the teicoplanin subcomponents is dependent upon the strain of microorganism and the fermentation conditions used, these may give rise to differences in the composition between the generic and reference product. In order to address the inconsistencies across the EU in terms of the requirements for generics of teicoplanin, a procedure was initiated in 2013 to ensure that the active substance is sufficiently characterized, new tests and limits were proposed, in addition to those currently specified in the monograph.
Gnosis has demonstrated the capability to obtain the same “Complex” profile of the originator, including specific ranges of subcomponents, being the first European company to obtain CEP in compliance with the new tests and limits.