Analysis of purity profiles of generic lisinopril tablets marketed in Croatia.

In view of an increasing number of generic drugs emerging, a comparative study was performed including the approved lisinopril preparations in the form of tablets marketed in Croatia, to compare purity profiles of generic drugs versus the original medicinal product. Several batches of each individual medicinal product at different stages of their shelf life were analyzed. Impurities were determined by means of high performance liquid chromatography (HPLC).

Regulating medicines in Croatia: five-year experience of Agency for Medicinal Products and Medical Devices.

Aim: To present the activities of the Agency for Medicinal Products and Medical Devices in the first 5 years of its existence and to define its future challenges.

Methods: Main activities within the scope of the Agency as a regulatory authority were retrospectively analyzed for the period from 2004-2008. Data were collected from the Agency's database and analyzed by descriptive statistics.