This state-of-the-art facility will be constructed in accordance with Croatian, European and US regulations, and will comply with the most stringent standards of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Construction is expected to finish during the beginning of 2009 and will be followed by validation and qualification activities, technology transfer and regulatory approvals. Željko Čović commented: “Recombinant DNA technology and biopharmaceutical production require specific knowledge, equipment and experience, assets that PLIVA is proud to have. The respective marketing potential and production technologies are strictly regulated and use small-size production lines, which yield gram or milligram quantities of products with outstanding market value, making the biogeneric arena exceptionally attractive.” Paul Bisaro confirmed that PLIVA would continue its biotechnological efforts within the Barr Group: “While the construction of this facility is a visible sign to the world of our commitment to leadership in biopharmaceutical products, the work already underway by the scientists and experts of both Barr and PLIVA demonstrates our investment in the science that will support our leadership. Within the next several years, consumers who pay tens of thousands of dollars a year for brand versions of biopharmaceutical prescriptions will have a more affordable option to products that will come out of our laboratories and manufacturing facilities.” |