Moehs, as a manufacturer of active ingredients, believes that quality is of paramount importance. Our goal is the manufacture of products that fully satisfy the needs of our customers, respecting the regulatory requirements and the laws in force in our markets. We are strongly committed to the manufacture of quality products that comply with the highest standards of quality, purity and effectiveness throughout their useful life.

 

Obtaining the certificate of adaptation of monographs of the European Pharmacopoeia (CEP) to DULOXETINA HCL, proves that we are qualified manufacturers. The European Directorate for the Quality of Medicines (EDQM) certifies that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia, after a long and extensive process of presenting the complete and detailed documentation.

The CEP establishes a bridge between the monographs of the European Pharmacopoeia and the need to prepare a file for the granting of licenses and, therefore, it is also a bridge between the industry and the health authorities.

It is a guarantee of qualification, since it is needed by manufacturers or suppliers who wish to apply for a marketing authorization for active substances or excipients to control the chemical purity and microbiological quality of their substance, products with TSE risk to evaluate the reduction of TSE risk according to the general monograph, herbal products used in the production or preparations of pharmaceutical products to be evaluated according to the suitability of the monograph for the control of herbal drugs and herbal drugs preparations.

Its main advantages are: centralized evaluation by the EDQM, recognized by all the member states of the European Pharmacopoeia Convention (36 countries), as well as by other countries, easing of the management of applications for marketing authorization (MAA) for medicinal products in these countries, and simplifies the approbation of a medicinal product compared to the active substance master file (ASMF) or European drug master file (EDMF).